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John Kitchens, MD, and Scott Krzywonos take stock of the biggest retina data readouts of 2026 — from a superiority study from Ocular Therapeutix to a Kodiak comeback and a gene therapy from Beacon that could be the first approval for an inherited retinal disease since Luxturna in 2017. Also discussed: topline data for remigromig (Merck/EyeBio) and Duravyu (EyePoint).

The conversation covers what each dataset means in clinical terms, which presentations at AAO are must-attends, and what happens when all these new mechanisms — TKIs, ABC polymers, Wnt pathway agonists, IL-6 inhibitors, and gene therapy — arrive in clinic around the same time.

The episode closes with a broader question: are we entering an era of retina that looks more like oncology, where doctors match individual patients to specific treatments rather than relying on trial and error?

Hosts: John Kitchens, MD, Scott Krzywonos

Topics Covered

Axpaxli / SOL-1 (Ocular Therapeutix)

A superiority study — rare in retina. Primary endpoint at month 9: Axpaxli patients maintained vision at a significantly higher rate than those treated with a single injection of aflibercept.

Study design selected for highly responsive patients, which may have produced a stronger-than-expected control arm response. More than half of aflibercept control patients went six months before needing rescue treatment.

Axpaxli holds a Special Protocol Assessment (SPA) from the FDA, which should support a cleaner approval pathway. NDA filing planned for 2026.

Darius M. Moshfeghi, MD, presents SOL-1 results at AAO Subspecialty Day, Friday, October 9, 4:35 PM.

Duravyu / LUGANO (EyePoint Pharmaceuticals)

Phase 3 non-inferiority study for wet AMD. Nine patients in the treatment arm drove the primary endpoint miss.

The LUCIA companion study remains the decisive data set; if positive, expect an NDA submission in 1H 2027.

Carl D. Regillo, MD, FACS, presents LUGANO results at AAO Subspecialty Day, Friday, October 9, 4:30 PM.

Zenkuda / DAYBREAK (Kodiak Sciences)

Phase 3 wet AMD study; three arms — Zenkuda (four monthly loading doses, then PRN with zero-fluid-tolerance AI retreatment criteria), tabirafusp-ted (four monthly loading doses, then every-other-month proactively), and aflibercept (three monthly loading doses, then every eight weeks).

Zenkuda: 7.2-letter vision gain vs. 7.6 for aflibercept. 54% of patients reached 6-month dosing at year 1 under strict treat-to-dryness criteria. 0% intraocular inflammation.

The key modification from KSI-301: Zenkuda includes 20% free drug for immediate drying effect, with 80% ABC-conjugated drug providing the approximately 20-day half-life and durability.

Tabirafusp-ted also met its primary endpoint, but added no additional vision gains vs. aflibercept. IL-6 inhibition may have a stronger case in DME and uveitic macular edema; ALTO Phase 3 in DME is actively enrolling.

Kodiak plans a Q4 2026 three-indication BLA for Zenkuda (wet AMD, diabetic retinopathy, RVO).

Charles C. Wykoff, MD, PhD, presents DAYBREAK results at AAO Subspecialty Day, Friday, October 9, 4:40 PM.

Remigromig / BRUNELLO (Merck)

Phase 2b/3 non-inferiority study for DME. Both doses (0.5 mg and 0.8 mg) demonstrated non-inferiority to monthly ranibizumab 0.5 mg at week 52.

A Wnt pathway agonist — not an anti-VEGF. Targets endothelial cell tight junctions in the retinal vasculature. Higher rates of PDR and vitreous hemorrhage in the remigromig arms vs. control; full data not yet seen beyond the press release.

John's read: likely an add-on to anti-VEGF, not a replacement. Anti-VEGF co-therapy should mitigate the proliferative signal. Target population: the roughly 40% of DME patients with persistent edema despite treatment (per DRCR Protocol I and Protocol T).

Monthly dosing is a practical disadvantage vs. Ozurdex; absence of cataract and IOP risk is the advantage.

BAROLO companion study expected Q1–Q2 2027.

Donald J. D'Amico, MD, presents BRUNELLO results at AAO Subspecialty Day, Saturday, October 10, 5:10 PM.

Laru-zova / VISTA (Beacon Therapeutics)

Pivotal Phase 3 gene therapy for X-linked retinitis pigmentosa — the first XLRP trial to meet its primary endpoint, and the first potential gene therapy approval in retina since Luxturna in 2017.

Primary endpoint: low luminance visual acuity responder rate (gain of 15+ letters at month 12). High-dose arm: 31%. Low-dose arm: 24%. Untreated control: 0%.

XLRP is more prevalent than RPE65-mediated LCA and has a characteristic inheritance pattern that may make family-based identification more tractable. Enrollment required VA of 20/32 or better — earlier diagnosis and genetic testing are prerequisites for treatment.

Robert A. Sisk, MD, FACS, FASRS, presents VISTA first-time results at AAO Subspecialty Day, Saturday, October 10, 4:13 PM.

The Bigger Picture: Precision Retina?

The arrival of multiple new mechanisms in close succession — TKIs, ABC polymers, Wnt agonists, IL-6 inhibitors, gene therapy — raises a question Charles C. Wykoff, MD, PhD, floated on the Kodiak investor call: is retina approaching an oncology-style era where specific patients are matched to specific treatments?

John's view: we're not there yet. The DRCR Retina Network is well-positioned to run the head-to-head comparison studies that would generate that evidence. AI may eventually help identify disease phenotypes that predict response to one mechanism vs. another — but the data to train it on don't exist yet.

Key Takeaways

Five major Phase 3 datasets in one year — SOL-1, LUGANO, DAYBREAK, BRUNELLO, and VISTA — each with different mechanisms, endpoints, and implications. Friday and Saturday afternoon at AAO Subspecialty Day are the sessions to be in the room for.

TKIs and Zenkuda are both targeting durability in wet AMD but via different mechanisms; real-world data will tell us whether the trial results hold outside controlled conditions.

Remigromig's safety signal in BRUNELLO will be the central topic at Dr. Don D'Amico's Saturday talk; the full data, not just the press release, will determine how seriously practices take the PDR risk.

VISTA represents a potential turning point for inherited retinal disease — and a reminder that the stakes in retina extend well beyond market dynamics.

Credits

Production & Marketing: Laura Brown | Business Operations: Liz Hogan

🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Sponsors

This episode is made possible by Genentech, maker of Vabysmo (faricimab-svoa). Purple Chair series at Vabysmo-HCP.com.

This episode is brought to you by Neurotech, makers of Encelto (revakinagene taroretcel-lwey). Learn more at encelto.com/ecp.

Breaking news: Kodiak Sciences announced this morning that both Zenkuda (tarcocimab tedromer) and tabirafusp-ted (KSI-501, tabirafusp alfa tedromer) met their primary endpoints in the Phase 3 DAYBREAK study in wet AMD — non-inferiority in vision gains vs. aflibercept at 1 year. Kodiak plans a Q4 2026 BLA filing for Zenkuda, covering five positive Phase 3 studies across wet AMD, diabetic retinopathy, and RVO.

John Kitchens, MD, and Scott Krzywonos break down what makes DAYBREAK's design unusual, why Kodiak's comeback from the KSI-301 miss matters, what 54% of patients on 6-month dosing actually means in a real-world context, and what the tabirafusp-ted data suggest about where IL-6 inhibition fits in retina.

Detailed results will be presented at AAO Subspecialty Day by Charles C. Wykoff, MD, PhD, on Friday, October 9, at 4:40 PM local time, New Orleans.

Hosts: John Kitchens, MD, Scott Krzywonos

Topics Covered

DAYBREAK: What the Data Show

Study design: Phase 3; treatment-naive wet AMD patients only; three arms — Zenkuda (four monthly loading doses, then PRN based on zero-fluid-tolerance retreatment criteria based on AI volumetric data), tabirafusp-ted (four monthly loading doses, then every-other-month proactively with monthly dosing if needed), and aflibercept 2mg (three monthly loading doses, then every eight weeks); primary endpoint: mean BCVA change from weeks 40 to 48.

Zenkuda primary endpoint: met (p=0.0007). Vision gains: 7.2 letters (Zenkuda) vs. 7.6 letters (aflibercept). Central subfield thickness reduction: approximately 135 µm in both arms. Durability: 54% of Zenkuda patients reached 6-month dosing at year 1; 62% reached at least 5 months.

Tabirafusp-ted primary endpoint: also met (p=0.0036). Anatomical key secondary endpoint also met (p<0.0001). No additional vision gains vs. aflibercept despite the added IL-6 inhibition.

Safety: Zenkuda showed 0% intraocular inflammation and a 0.5% cataract adverse event rate (vs. 0.9% for aflibercept). Tabirafusp-ted showed 0% cataract adverse events.

What Makes This Design Different

Zero-fluid-tolerance retreatment criteria: most trials allow some residual fluid in pursuit of extended intervals. DAYBREAK allowed none — any fluid on AI volumetric analysis triggered retreatment. This is closer to how most retina specialists actually treat in clinic, which may narrow the gap between trial outcomes and real-world results.

AI-assisted retreatment: Kodiak used an AI volumetric fluid tool assessing the central 3 mm of the OCT to determine retreatment eligibility. The combination of strict criteria and a 20-day half-life for Zenkuda is what may drive the durability signal.

Previously treated patients: DAYBREAK enrolled treatment-naive patients only. The companion ALTO Phase 3 study will assess both treatment-naive and previously treated patients with tabirafusp-ted in DME, actively enrolling now.

Kodiak's Comeback from KSI-301

KSI-301, Kodiak's prior ABC-platform agent, missed its primary endpoint. Kodiak modified the approach with Zenkuda, allowing some free drug alongside the conjugated biopolymer to produce immediate effect on loading, then relying on the conjugated drug for durability. The ~20-day intravitreal half-life of Zenkuda exceeds what is seen with conventional anti-VEGF agents.

What the Tabirafusp-ted Data Mean for IL-6

No additional vision gains with tabirafusp-ted vs. aflibercept despite monthly/bimonthly dosing. John's read: IL-6 may not add meaningful benefit in treatment-naive wet AMD. Better indications likely exist: uveitic macular edema and DME (where vascular leakage and inflammation are more tightly linked). Post-hoc analyses to identify wet AMD subgroups that might benefit are planned.

What's Next

Zenkuda BLA: Q4 2026 filing, covering five positive Phase 3 studies across wet AMD, diabetic retinopathy, and RVO.

ALTO: Phase 3 study of tabirafusp-ted in DME; enrolling now; includes both treatment-naive and previously treated patients.

Full data presentation: Charles C. Wykoff, MD, PhD, presents DAYBREAK results at AAO Subspecialty Day, Friday, October 9, 4:40 PM, New Orleans.

Key Takeaways

Both Zenkuda and tabirafusp-ted met their primary endpoints in DAYBREAK — Kodiak's comeback from the KSI-301 miss is complete, at least clinically.

54% of Zenkuda patients on 6-month dosing under zero-fluid-tolerance criteria is a meaningful durability signal, and the strict retreatment protocol makes these results more directly comparable to real-world practice than most trials.

Tabirafusp-ted's vision data in wet AMD don't support IL-6 as a meaningful add-on in treatment-naive patients; DME and uveitic macular edema remain the more compelling targets.

Kodiak plans a Q4 2026 BLA filing for Zenkuda across three indications. If approved, this would be an important new mechanism in wet AMD.

Credits

Production & Marketing: Laura Brown | Business Operations: Liz Hogan

🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Breaking news: Merck announced this morning that remigromig (MK-3000), its investigational tetravalent tri-specific Wnt pathway agonist, met the primary endpoint of the Phase 2b/3 BRUNELLO trial for diabetic macular edema. Both the 0.5 mg and 0.8 mg doses independently demonstrated non-inferiority to 0.5 mg ranibizumab monthly at week 52.

John Kitchens, MD, and Scott Krzywonos break down the topline data, the safety signals to watch (and how they might be mitigated in real-world treatment), where remigromig fits alongside anti-VEGF and steroid therapy, and what the BAROLO companion study needs to show before Merck can engage regulators for approval.

Full data presentation by Donald J. D'Amico, MD, at AAO Subspecialty Day, Saturday, October 10, 5:10 PM local time, New Orleans.

Editors' Note: A previous version of this episode understated the complexity of the Wnt signalling pathway. It has been edited for accuracy.

Hosts: John Kitchens, MD, Scott Krzywonos

Topics Covered

BRUNELLO: What the Data Show

Trial design: randomized, double-masked Phase 2b/3; 984 participants with DME; three arms — remigromig 0.5 mg, remigromig 0.8 mg, and ranibizumab 0.5 mg (active control); all dosed monthly; primary endpoint: mean change from baseline in BCVA at week 52.

Primary endpoint: met. Both doses of remigromig independently demonstrated non-inferiority to ranibizumab at week 52.

Safety signals: higher rates of proliferative diabetic retinopathy (PDR), vitreous hemorrhage, and treatment discontinuations due to adverse events in the remigromig arms vs. ranibizumab. Further analyses are underway. Merck described both doses as generally well tolerated.

The Mechanism: What the Wnt Pathway Does

Remigromig is not an anti-VEGF, but rather a tetravalent, tri-specific antibody designed to activate the Wnt pathway, which is involved in the repair and maintenance of the blood-retinal barrier. The target: endothelial cell tight junctions in the retinal vasculature — specifically relevant in DME, where vascular leakage is the central pathology.

Where It Fits: Combination vs. Monotherapy

BRUNELLO was a monotherapy study — remigromig was not tested in combination with anti-VEGF. Why: a combination study would likely have required a superiority design (a higher bar than noninferiority). Merck's clearest regulatory path was monotherapy noninferiority first.

If approved, John expects remigromig to function as an add-on, not a replacement — similar to how a second-line glaucoma agent like brimonidine coexists with prostaglandin analogs. The target patient: the roughly 40% with persistent DME edema after anti-VEGF (per DRCR Protocol I and T data).

Ranibizumab is a defensible comparator: RIDE/RISE and Protocol T all-comers data show no statistically significant difference vs. aflibercept across the full population.

Competitive Context: Ozurdex and Tiespectus

If approved, remigromig may compete most directly with Ozurdex (dexamethasone intravitreal implant 0.7 mg, AbbVie) in the non-anti-VEGF DME add-on space. Monthly dosing is remigromig's disadvantage vs. Ozurdex's less frequent schedule; the absence of cataract and IOP risks is its advantage.

Tiespectus (MK-8748): Merck's second ophthalmology program — a bispecific antibody that directly activates Tie2 and inhibits VEGF. Being studied first in wet AMD. John's view: remigromig gets Merck on base; tiespectus has home run potential if the data hold.

What's Next

BAROLO: the companion Phase 2b/3 trial in DME; topline data expected Q1–Q2 2027. Remigromig is also being evaluated in SUPER TUSCAN, a Phase 2 proof-of-concept study in wet AMD and RVO. Any regulatory submission pathway for DME depends on the totality of BRUNELLO and BAROLO together.

Full data: Donald J. D'Amico, MD, presents BRUNELLO 1-year results at AAO Subspecialty Day, Saturday, October 10, 5:10 PM, New Orleans.

Key Takeaways

BRUNELLO hit its primary endpoint — remigromig is non-inferior to ranibizumab in DME, representing the first positive Phase 3 data for a non-anti-VEGF, non-steroid DME treatment.

The PDR and vitreous hemorrhage signals are real and need characterization; anti-VEGF co-therapy may be the practical mitigation, but that remains to be demonstrated in a combination study.

Remigromig is likely an add-on, not a replacement — the 40% of patients with persistent DME edema on anti-VEGF are the target population.

BAROLO data (Q1–Q2 2027) will determine whether Merck has a regulatory submission package. Tiespectus follows behind.

Credits

Production & Marketing: Laura Brown | Business Operations: Liz Hogan

🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Breaking news: Beacon Therapeutics announced positive topline data from the VISTA pivotal trial of laru-zova (laruparetigene zovaparvovec) for X-linked retinitis pigmentosa (XLRP) — the first gene therapy trial in XLRP to reach its primary endpoint.

John Kitchens, MD, and Scott Krzywonos break down the study design, the FDA-endorsed low luminance visual acuity endpoint, what the dose response data actually says (or doesn't say), and what could complicate the path to approval.

The VISTA data will be presented in full by Robert A. Sisk, MD, at AAO Subspecialty Day on Saturday, October 10, at 4:13 PM local time in New Orleans.

Hosts: John Kitchens, MD, Scott Krzywonos

Topics Covered

VISTA Trial: What the Data Show

Study design: 85 males aged 12–48 with XLRP; enrollment visual acuity 20/32 to no worse than 20/200; high- and low-dose arms compared with untreated control patients (no sham arm); 1-year primary endpoint.

Primary endpoint: low luminance visual acuity (LLVA) responder rate — defined as a gain of ≥15 letters at month 12. High-dose arm: 31% of patients reached this threshold. Low-dose arm: 24%. Untreated control arm: 0%. The differential between treated and untreated is the signal; the difference between dose arms is small.

Secondary endpoints: gain of ≥10 letters in LLVA (low dose 59%, high dose 48%, untreated 4%); mean macular sensitivity on microperimetry (statistically significant in the low dose, not the high dose).

Safety: described as good in the press release; no major safety signals reported.

The FDA-Endorsed Endpoint

LLVA measures vision under reduced light conditions — the primary functional deficit in XLRP. Standard BCVA is not well-suited for a disease where night vision failure is the central complaint.

Before study launch, Beacon likely aligned with the FDA on this endpoint — a pre-agreement that doesn't guarantee approval but confirms both parties entered the trial with shared expectations on how benefit would be measured.

Dose Response and Approval Path

The absence of a clear dose response — low dose slightly outperforming high dose on some endpoints — may raise FDA questions about dose selection. Gene therapy pharmacokinetics are not always linear, which provides some rationale. Manufacturing capacity and scalability will also be subject to scrutiny, given the novelty of the platform.

Beacon has announced plans to pursue regulatory submissions, including to the FDA.

Clinical Context

XLRP is more prevalent than RPE65-mediated LCA (the target of Luxturna, Spark Therapeutics) and has a characteristic X-linked inheritance pattern — affected males, carrier females — that may make family-based identification more feasible than prior inherited retinal disease programs.

Enrollment in VISTA required VA of 20/32 or better, which means earlier diagnosis and genetic testing will be essential to identify candidates before disease progression.

The first full data presentation: Robert A. Sisk, MD, Professor of Ophthalmology, Cincinnati Eye Institute/University of Cincinnati, presents VISTA first-time results at AAO Subspecialty Day, Saturday, October 10, 4:13 PM local time, New Orleans.

Key Takeaways

VISTA is the first gene therapy trial in XLRP to reach its primary endpoint — the first potential gene therapy approval in retina since Luxturna in 2017.

The FDA-endorsed LLVA endpoint reflects a deliberate effort to measure what actually matters to patients with XLRP: the ability to function in low light.

Earlier diagnosis and genetic testing will be prerequisites for treatment; the X-linked inheritance pattern may make family-based identification more tractable than prior IRD programs.

Full data at AAO Sub Day, October 10, 4:13 PM local time. More to come.

Credits

Production & Marketing: Laura Brown | Business Operations: Liz Hogan

🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

John Kitchens, MD, and Scott Krzywonos break down the AAO 2026 annual meeting in New Orleans (October 9–12) — whether it still matters, what to catch at Subspecialty Day, and which late-breaking Phase 3 data presentations could move the field. Each host shares their top four talks, and the Vitreoretinal View covers the surgical program.

A quick correction from the prior episode: the SOL-1 primary endpoint was at month 9, not month 6, as stated in our previous episode. Corrections welcome at info@retinup.com.

Hosts: John Kitchens, MD, Scott Krzywonos

Topics Covered

AAO 2026: Does It Still Matter?

In-person attendance may be down post-COVID, but virtual access has expanded the meeting's reach significantly. Still a premier venue for late-breaking Phase 3 data and surgical education. New Orleans in October doesn't hurt.

John is on the podium in two places: the 2026 Debate Session (Friday, 2:45 PM — No Flap for Macular Hole) and a vitrectomy for floaters talk at Refractive Subspecialty Day. Plus, John pays tribute to Kirk Packo, MD — the legendary AAO debater — and his famous 2006 New Orleans talk calling out industry over Avastin access.

John's Top Four Talks

No. 4 — Friday, 5:10 PM: Ehsan Rahimy, MD, presents 36-month safety data from the PRIMA photovoltaic retinal implant trial in geographic atrophy. A European device that has hit mainstream news; risk of accelerating atrophy and debate over whether VA gains reflect true restoration or magnification make this one to watch.

No. 3 — Friday, 5:05 PM: Raj K. Maturi, MD, presents 12-month topline results from the Phase 2 ArMaDa trial of OCU-410, a modifier gene therapy for GA. Back-to-back with PRIMA; gene therapy for GA is the right target given the need for sustained delivery.

No. 2 — Saturday, 4:56 PM: Arshad M. Khanani, MD, MA, presents Phase 2 ELAAVATE data for RGX-314 (Regenxbio), a subretinal gene therapy for center-involved DME. Subretinal and suprachoroidal delivery routes both in development; data could signal what gene therapy for DME looks like before the Phase 3 wave hits.

No. 1 — Saturday, 5:10 PM: Donald J. D'Amico, MD, presents the BRUNELLO pivotal trial results for Remigromig (MK-3000, Merck) in DME — a Wnt pathway inhibitor that targets endothelial cell tight junctions rather than VEGF. A genuinely new mechanism; if it wins on VA and drying, it could be additive to anti-VEGF. Monthly ranibizumab as the comparator is defensible given the ride/rise data and Protocol T all-comers results. Merck's second program, tuspetinib (Tie2 activator, ANG1 pathway), is next up in the pipeline.

Scott's Top Four Talks

No. 4 — Friday, 8:30 AM: Jason Hsu, MD (Wills Eye Hospital), Top Journal Articles That Influenced My Practice. Not a single dataset — a real-world appraisal of what actually breaks through into practice.

No. 3 — Saturday, 4:37 PM: Nisha Acharya, MD, presents week 52 MEERKAT and SANDCAT data for vamikibart in uveitic macular edema. Week 16 data were presented at AAO 2025 and ARVO 2026; the 1-year read will be more definitive. Interesting wrinkle: higher dose won in MEERKAT, lower dose in SANDCAT.

No. 2 — Friday, 4:40 PM: Charles C. Wykoff, MD, PhD, presents the DAYBREAK Phase 3 trial for Kodiak Sciences — a three-arm study comparing KSI-301 (ABC anti-VEGF), KSI-501 (ABC anti-VEGF + anti-IL-6), and aflibercept. First time (we think) a sponsor has run two of their own candidates head-to-head against a control.

No. 1 — Saturday, 4:13 PM: Robert A. Sisk, MD, presents first-time pivotal VISTA trial results for laru-zova gene therapy (Beacon Therapeutics) for X-linked RP. Could be the second gene therapy approved in retina, and the first since Spark in 2017. Larger treatable population than RPE65-mediated LCA; safety around subretinal delivery in a pigmented retina will be key.

Vitreoretinal View: Surgical Talks at Subspecialty Day

Friday, 8:16 AM — Ninel Z. Gregori, MD: Subretinal administration of photoreceptor precursor cells in RP (Surgical Videos: Cool Cases and Complications). Subretinal photoreceptor delivery is distinct from gene therapy; anatomic and functional outcomes to watch.

Friday, 11:04 AM — Aleksandra V. Rachitskaya, MD: When to Worry and When Not to Worry About Retinoschisis. Schisis-related detachments are technically demanding with high PVR risk; looking for pearls on when to operate, laser options, tamponade choice.

Friday, 11:11 AM — Colin A. McCannel, MD: A Decade of 27-Gauge Vitrectomy Surgery. Less than 5% of US surgeons use 27-gauge; Alcon Unity system is optimizing flow and stiffness. Does 25-gauge still do everything 27 can without the compromises?

Saturday, 3:45 PM — Omesh P. Gupta, MD: Gore-Tex Scleral-Fixated IOL Technique (How Do I Do It).

Saturday, 3:52 PM — Murtaza K. Adam, MD: Yamane Technique IOL Placement (How Do I Do It).

Saturday, 4:06 PM — Glenn C. Yiu, MD, PhD: Suprachoroidal Injection Tips and Tricks. Increasingly relevant as suprachoroidal gene therapy delivery (RGX-314) advances and approved suprachoroidal steroid delivery matures.

Key Takeaways

AAO 2026 features an unusually dense late-breaking data slate: BRUNELLO, DAYBREAK, VISTA, MEERKAT/SANDCAT, PRIMA, and ArMaDa all read out at the same meeting.

BRUNELLO is the most mechanistically novel: a Wnt pathway inhibitor for DME that could eventually combine with anti-VEGF. VISTA is the most consequential for the inherited retinal disease field if positive.

Suprachoroidal delivery and 27-gauge vitrectomy are two surgical trends worth watching across multiple talks.

Correction: the SOL-1 primary endpoint was at month 9, not month 6, as stated on our previous episode.

Sponsors

This episode is made possible by Genentech, maker of Vabysmo (faricimab-svoa). Hear peer perspectives and case studies in the Purple Chair series, including Dr. David A. Eichenbaum on a real-world DME patient, at Vabysmo-HCP.com.

This episode is brought to you by Alcon, a global leader in eye care, including Unity VCS. Learn more at unityvcs.com.

Credits

Production & Marketing: Laura Brown | Business Operations: Liz Hogan

🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

John Kitchens, MD, and Scott Krzywonos take stock of the three biggest retina news stories of 2026 — the SOL-1 superiority data for Axpaxli (Ocular Therapeutix), the FDA approval of Lytenava (Outlook Therapeutics), and the LUGANO Phase 3 (near) miss for Duravyu (EyePoint Pharmaceuticals) — and look ahead to three imminent late-phase readouts that could reshape the field before year's end: DAYBREAK for Zenkuda (Kodiak), BRUNELLO for Restoret (Merck/EyeBio), and ARCHER 2 for vonaprument (Annexon).

Carl J. Danzig, MD, then joins for a candid conversation about leaving a solo retina practice after 14 years, navigating a non-compete, commuting across Alligator Alley, and what it actually costs — personally and professionally — to make a major mid-career professional transition. He recently joined Fort Lauderdale Eye Institute as one of four retina specialists, beginning to see patients there on August 24, 2026.

Hosts: John Kitchens, MD, Scott Krzywonos

Topics Covered

2026 Pipeline Check-In: Catching Our Breath

Axpaxli / SOL-1 (Ocular Therapeutix): first superiority study in retina; at week 36, 74% of Axpaxli patients maintained vision vs. 56% on a single aflibercept injection; at 1 year, 66% of Axpaxli patients had not lost 10 letters; NDA filing planned for 2026.

Lytenava (Outlook Therapeutics): FDA-approved July 2026 for wet AMD — the first FDA-approved ophthalmic formulation of bevacizumab; measured commercial rollout planned for Q4 2026; full commercialization early 2027. Key unresolved question: impact on compounded bevacizumab access, particularly for non-wet AMD indications including DME, CRVO, BRVO, and myopic CNV.

Duravyu / LUGANO (EyePoint Therapeutics): primary non-inferiority endpoint missed in the full dataset; attributed to nine outlier patients in the treatment arm with vision loss unrelated to wet AMD; ad hoc analysis excluding those patients showed non-inferiority; LUCIA companion study topline data expected Q4 2026.

2026 Pipeline Check-In: What's Coming

Kodiak Sciences — DAYBREAK (Zenkuda / KSI-501): Phase 3 non-inferiority study for wet AMD; two investigational arms vs. aflibercept; topline data expected September 2026. Kodiak's prior KSI-301 missed its primary endpoint; lessons learned informed DAYBREAK's design.

Merck — BRUNELLO (Restoret / MK-3000): Wnt pathway agonist antibody acquired via EyeBio; Phase 3 non-inferiority trial for DME; data expected within 4 to 6 weeks of recording; a second Merck program — an ang-1 upregulator and VEGF inhibitor designed to activate the Tie2 receptor rather than merely inhibiting ang-2 — follows behind.

Annexon — ARCHER 2 (vanoprument / ANX007): C1q complement inhibitor for GA; distinct mechanism from C3 (pegcetacoplan) and C5 (avacincaptad pegol) inhibitors; Phase 2 showed a visual acuity benefit without slowing lesion growth; hypothesis: C1q inhibition protects photoreceptors upstream of RPE loss, with atrophy reduction expected to emerge over 12–24 months; Phase 3 primary endpoint is vision preservation, not lesion growth.

Carl J. Danzig, MD, on Switching Practices at Mid-Career

Background: Temple University medical school, Wills Eye tumor research, residency at Charles Drew (transferred to SUNY Downstate after program closure), fellowship at UT Southwestern; joined Rand Eye Institute as the practice's first and only retina specialist in 2012.

Solo practice realities: PI on 59 clinical trials as a solo retina specialist in an anterior segment practice; required extensive coverage arrangements and leveraged a full network of South Florida retina colleagues; elected to Retina Society.

Why he left: felt like "salmon swimming against the current" in an anterior segment culture; outgrowing his role; needed partners, shared call, and a practice aligned with his research identity and professional goals.

The transition year: geographic restriction meant commuting from Fort Lauderdale to Bonita Springs (Advanced Retina Institute) — across Alligator Alley — Tuesday through Thursday most weeks; often away five to six nights at a time including commercial speaking and international meetings.

The real costs: income went to zero during the gap; anxiety about the non-compete timeline; mental load of solo parenting for his wife; being a diminished version of himself at home after long stretches away. "Phil Rosenfeld, MD, told me I jumped out of an airplane holding my family's hand and no one had a parachute."

Fort Lauderdale Eye Institute: one of four retina specialists; seven minutes from home; active clinical trial program; practice aligned with his values. First patient day: August 24, 2026.

Advice to anyone considering a mid-career move: know your worth, don't undervalue yourself, move sooner rather than later if the fit is wrong, and build your network before you need it.

Key Takeaways

The three biggest retina stories of 2026 — SOL-1, Lytenava, and LUGANO — set up a fall season with multiple Phase 3 readouts that could further reshape the treatment landscape.

Annexon's ARCHER 2 is the most mechanistically distinct GA program in Phase 3 — a C1q inhibitor targeting photoreceptors upstream of RPE loss.

Leaving a practice at mid-career is a financial, legal, logistical, and deeply personal decision — Carl Danzig's year-long transition is a useful blueprint for anyone considering it.

Network-building early in training is the single most durable investment a retina specialist can make.

Sponsors

This episode is made possible by Genentech, maker of Vabysmo (faricimab-svoa). Hear peer perspectives and case studies in the Purple Chair series at Vabysmo-HCP.com.

This episode is brought to you by Ocular Therapeutix, a biopharmaceutical company working to redefine the retina experience across drug development, treatment, and outcomes. Learn more at OCUTX.com.

Credits

Production & Marketing: Laura Brown | Business Operations: Liz Hogan

🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Jay S. Duker, MD, President & CEO of EyePoint Pharmaceuticals, joins John and Scott to parse the LUGANO Phase 3 topline data — just three days after release. He walks through Duravyu's MOA, what the nine outlier patients in the study actually represent, why the secondary data are compelling, and what LUCIA needs to show for an NDA filing in 1H 2027.

Then Miles Harper stops by the VitreoRetinal View to discuss why some innovations in the OR fail, why others succeed, and which surgical applications of AI might feasibly appear in the near future.

Show Notes:

Guest: Jay S. Duker, MD – President & CEO, Board Director, EyePoint Pharmaceuticals; former Professor & Chair, Department of Ophthalmology, Tufts Medical Center and Tufts University School of Medicine

Show Summary

Three days after EyePoint Pharmaceuticals released topline LUGANO Phase 3 data, Jay S. Duker, MD, President & CEO, joins John Kitchens, MD, and Scott Krzywonos to break down what the results actually mean.

Duravyu (vorolanib) missed its primary non-inferiority endpoint in the full dataset of LUGANO — confounded by nine patients in the treatment arm who lost 15 or more letters for reasons unrelated to wet AMD control. Dr. Duker explains what those nine cases represent, why the secondary data tell a different story, and what LUCIA — the companion Phase 3 trial with topline data expected in Q4 2026 — will need to show for an NDA submission in 1H 2027.

John and Scott offer their own read on the interview: what surprised them, why the re-randomization analysis matters, and why TKIs are still likely to have a meaningful role in retina.

In the Vitreoretinal View segment, industry consultant and friend of the pod Miles Harper stops by to examine why some surgical innovations fail while others experience modest success. Scott and Miles also speculate as to which surgical applications of AI technology could soon enter the stage.

Hosts: John Kitchens, MD, Scott Krzywonos

Topics Covered

Duravyu: Mechanism & Background

Vorolanib is a small-molecule TKI with activity against all VEGF receptors — working intracellularly at the receptor level, unlike approved anti-VEGFs that block the ligand extracellularly. Additional activity against PDGF (antifibrotic) and JAK1 (anti-inflammatory via IL-6 pathway). Delivered via Durasert E bioerodible sustained-release insert; 2.7 mg every six months.

Previously tested orally in wet AMD with efficacy but hepatotoxicity at 200–300 mg daily; intravitreal dose results in only picogram-level systemic absorption. Tested in DAVIO (Phase 1), DAVIO 2 (Phase 2 wet AMD, 100% previously treated), and VERONA (Phase 2 DME) before Phase 3.

LUGANO Results: The Good

Safety: no increase in cataracts or IOP; single case of intraocular inflammation (0.5%); only 6% discontinuation rate in each arm, none due to study drug; safety confirmed with re-injection at month eight — the first TKI Phase 3 trial to read out with re-injection data.

Anatomic control: 4-µm difference in retinal thickness vs. aflibercept 2 mg at week 56. Supplement-free subgroup (~54% of Duravyu eyes at week 56) was non-inferior to the control arm with only a 3-µm OCT difference.

Treatment burden: 42% reduction vs. on-label aflibercept; approximately two fewer injections per year. At week 32, 76% of Duravyu patients were supplement-free.

Previously treated population: 25% of patients were previously treated — the first wet AMD Phase 3 trial to include this population; informed by DAVIO 2, which enrolled 100% previously treated patients and produced strong results.

LUGANO Results: The Primary Endpoint Miss

Control arm outlier performance: historically, ~4% of aflibercept 2 mg patients lose 15+ letters in Phase 3 wet AMD trials; in LUGANO, only 0.5% did — an extraordinary result that raises questions about randomization luck rather than drug performance.

The nine outlier patients: six lost vision due to GA progression, two due to glaucoma, one due to retinal detachment (repaired, but phakic — developed cataract). EyePoint's position: these losses were not related to Duravyu or lack of wet AMD control; GA data from the trial does not support drug-induced acceleration.

Re-randomization analysis: EyePoint randomly redistributed the 15+ letter losers across both arms ten times; in every simulation, Duravyu was non-inferior, with a mean difference of -1.3 to -2.0 letters — well within the non-inferiority margin.

Regulatory Path Forward

LUCIA topline data expected Q4 2026; if positive, NDA submission planned for 1H 2027. Precedents for one positive and one missed Phase 3: pegcetacoplan (DERBY/OAKS) and Lytenava. Dr. Duker: the FDA evaluates totality of data including safety, burden reduction, and clinical benefit — a positive LUCIA plus the LUGANO secondary data could constitute a compelling package.

Key Takeaways

Duravyu's LUGANO miss appears to be driven by statistical bad luck — nine patients, unrelated to wet AMD, in one arm — not a drug failure. The secondary data are strong.

The re-randomization analysis gives meaningful confidence that regression to the mean in LUCIA should produce a non-inferior result.

A positive LUCIA trial, combined with LUGANO's secondary data, may be sufficient for FDA approval — precedent exists for one missed and one positive Phase 3.

TKIs work as a class: treatment-free interval data from LUGANO are consistent with SOL-1, regardless of primary endpoint outcome.

Credits

Production & Marketing: Laura Brown | Business Operations: Liz Hogan

🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Breaking news: EyePoint Pharmaceuticals announced LUGANO Phase 3 topline data this morning. Duravyu, an investigational sustained-release TKI for wet AMD, did not meet its primary non-inferiority endpoint in the full dataset — confounded by nine patients in what EyePoint is calling an asymmetric cohort. John Kitchens, MD, and Scott Krzywonos break down what it means, what comes next, and why TKIs still win as a class.

Show Summary

Breaking news: EyePoint Pharmaceuticals announced topline data from LUGANO, the first of two pivotal Phase 3 trials evaluating Duravyu (vorolanib) for wet AMD, on the morning of August 17, 2026.

The primary non-inferiority endpoint was not met in the full dataset. EyePoint attributes this to an asymmetric cohort of nine patients in the treatment arm whose outcomes significantly skewed the results. In an unplanned ad hoc analysis excluding those nine patients, Duravyu was non-inferior to aflibercept 2 mg. Safety was clean, treatment-free intervals were compelling, and the companion LUCIA study remains on track for Q4 2026 topline data.

John Kitchens, MD, and Scott Krzywonos recorded this episode before the market opened to break down the study design, the ad hoc analysis question, and what the FDA is likely to do with these data. Plus, they examine why TKIs as a class — and some other companies — may be the real winners from this morning's news.

Hosts: John Kitchens, MD, Scott Krzywonos

Topics Covered

LUGANO Topline Data: What Happened

Study design: randomized, double-masked, non-inferiority trial; Duravyu 2.7 mg every six months vs. aflibercept 2 mg every other month (EOM); 211 patients in the treatment arm; a significant percentage of patients were previously treated — an unusual and real-world-reflective design feature; primary endpoint assessed at weeks 52 and 56.

Primary endpoint: not met in the full dataset; control arm performed exceptionally well — no patients lost three or more lines of vision in the first six months, compared to approximately 5% in historical wet AMD Phase 3 comparators.

The asymmetric cohort: nine patients in the treatment arm drove the primary endpoint miss; EyePoint characterizes these as an atypical subgroup. In an unplanned ad hoc analysis excluding these nine patients, Duravyu was non-inferior to the control arm.

Ad hoc analysis: not a pre-specified endpoint; FDA may consider it but likely will not base approval on it alone. The key question is whether LUCIA — the companion trial — delivers a clean positive result. John's view: LUCIA will need to be positive for any approval pathway; the FDA has approved products on one pivotal trial before (e.g., pegcetacoplan in DERBY/OAKS), so a strong LUCIA result may be sufficient.

Treatment-free intervals: approximately 42% reduction in treatment burden vs. aflibercept; roughly consistent with data from SOL-1 — validating the TKI mechanism as durable. At week 32, 76% of Duravyu patients were supplement free.

Safety: clean; no ocular inflammation, vasculitis, or unexpected safety signals; consistent with prior TKI studies and anti-VEGF experience.

What It Means for the Field

TKIs win as a class: treatment-free interval data confirm durability and mechanism; the question is not whether TKIs work but how they will be positioned alongside next-generation anti-VEGFs.

Second-generation anti-VEGFs as potential beneficiaries: aflibercept 8 mg and faricimab approximate extended intervals with approved labeling; a delayed or complicated TKI approval pathway could strengthen their near-term positioning.

Study design implications: John raises the question of whether future TKI trials will exclude patients with geographic atrophy or other confounders; enrollment criteria may tighten, potentially slowing trial timelines.

AI and enrollment: Scott raises the possibility that AI-assisted health record analysis could better identify appropriate candidates in real time — particularly relevant as trials increasingly enroll previously treated patients.

What's Next

LUCIA topline data: expected Q4 2026; if positive, EyePoint plans NDA submission in 1H 2027.

Upcoming RetinUp episode: John and Scott plan to speak with someone from EyePoint Pharmaceuticals to go deeper on the data; additional subgroup analyses will be presented at the Retina Society Annual Meeting, September 23–26, 2026.

Key Takeaways

LUGANO missed its primary endpoint, but EyePoint argues the result was driven by nine atypical patients — not a failure of the drug.

The ad hoc analysis showing non-inferiority is hypothesis-generating, not approval-enabling; LUCIA must be positive for an NDA to proceed.

TKIs work: treatment-free interval data from LUGANO are consistent with SOL-1, reinforcing the class mechanism.

All eyes are on LUCIA in Q4 2026.

Credits

Production & Marketing: Laura Brown | Business Operations: Liz Hogan

🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

The companion piece to RetinUp’s previous episode on biosimilars is here, featuring an oncologist who has lived through biosimilar disruption for the past decade. Stephen "Fred" Divers, MD, CMO of the American Oncology Network, joins John and Scott to share what oncology has learned from nearly a decade of biosimilar use: the ASP deterioration cycle, payer formulary pressure, the race to the bottom, and what retina should do differently as its own biosimilar era accelerates.

During the Vitreoretinal View segment, John discusses his fresh move to Boulder, sharing what it's like to operate in a new OR for the first time in years — new staff, new preferences to rebuild, and a new clinical reality: operating at 5,400 feet above sea level requires adjusting gas concentrations, counseling patients about altitude travel, and understanding why the vacuum on a vitrectomy machine behaves differently.

Hosts: John Kitchens, MD, Scott Krzywonos

Topics Covered

Biosimilars in Oncology: Lessons for Retina (Stephen "Fred" Divers, MD)

History: biosimilars entered the EU in 2005, the US in 2008 under the 351(k) pathway; oncology has roughly a decade of meaningful real-world experience.

The ASP deterioration cycle: when biosimilars enter the market, manufacturers offer rebates to drive prescribing behavior; those rebates fold into ASP prospectively at roughly six months, causing progressive price deflation. With each additional market entrant, competition intensifies and the race to the bottom accelerates.

The life cycle: the first biosimilar offers meaningful margin; by the second or third entrant, margins erode significantly. Manufacturers may pull products, let ASP reset, then reinsert. Ironically, the originator drug can eventually offer the best margin — after cycling through multiple biosimilars.

Payer formulary mandates: when payers limit formulary to a single biosimilar, practices can become underwater if that product takes a price increase before ASP catches up. Dr. Divers' approach: push back on single-product mandates and discourage manufacturers from taking price increases after securing guaranteed market share.

Formulary management: keep less than 48 hours of drug on hand; constantly renegotiate contracts as new biosimilars enter; treat formulary decisions as a quarterly exercise, not an annual one.

Patient experience: biosimilar transitions are largely invisible to patients from an efficacy and safety standpoint; batch-to-batch variability exists even within originator biologics, which is part of the scientific rationale for the biosimilar framework.

340B context: a program originally designed for underserved clinics treating HIV patients that expanded exponentially into hospital systems, now accounting for 50–60% of drug dispensing nationally. Creates perverse incentives that complicate biosimilar adoption decisions in oncology.

What retina should do differently: build operational flexibility for frequent formulary changes; don't set and forget; invest in pharmacy infrastructure; expect continuous renegotiation; and be prepared for the margin on any given biosimilar to disappear faster than anticipated.

Vitreoretinal View: Operating in a New OR — and at Altitude

John has joined Rocky Mountain Retina Associates in Boulder, Colorado, alongside Geeta Lalwani, MD.

New OR realities: starting fresh means rebuilding every case card preference — forceps, drape, glove size, block needle, prep protocol, etc. An email requesting a case card was the prompt that made John realize how much institutional knowledge travels with a surgeon invisibly.

First days: stick with the familiar; introduce changes only once settled. Forceps especially — "like tennis shoes, you don't change brands that often." Alcon and Zeiss reps were on-site to support the transition.

Operating at altitude (5,400 feet): SF6 gas concentration must be reduced compared to sea level use; John typically uses 28–30% SF6 at Lexington's elevation; this must be adjusted in Boulder. Patients must be counseled against travel above 7,000–9,000 feet until the bubble resolves — patients who live at altitude must plan accordingly.

Vacuum performance: the Alcon Constellation cannot achieve the same vacuum at 5,400 feet as at sea level; surgeons operating at altitude should be aware of this mechanical limitation and adjust technique accordingly.

Key Takeaways

Biosimilar margins are meaningful early and deteriorate fast — retina specialists should plan for continuous formulary management, not annual decisions.

Payer formulary mandates to a single biosimilar are the highest-risk scenario; practices should push back and keep options open.

Biosimilars are clinically safe and effective; the challenge is entirely economic and operational, not clinical.

Operating in a new OR requires rebuilding institutional knowledge from scratch — and at altitude, requires recalibrating both gas concentrations and patient counseling.

Sponsors

RetinUp is an editorially independent podcast supported with advertising.

This episode is made possible by Genentech, maker of Vabysmo (faricimab-svoa). Watch their Purple Chair Series at Vabysmo-hcp.com.

Learn more about Alcon’s Unity VCS at UnityVCS.com.

Credits

Production & Marketing: Laura Brown | Business Operations: Liz Hogan

🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Bob Jahr, President & CEO of Outlook Therapeutics, joins John and Scott for one of his first interviews since the Lytenava (bevacizumab-vikg) FDA approval on July 24, 2026. He walks through the long road to approval — three complete response letters, a formal dispute resolution appeal, and a final label in hand without a single additional safety or efficacy data commitment — and shares what's ahead for the US commercial launch.

Scott then sits down with Miles Harper, an independent consultant who has spent his career at the intersection of ophthalmology, medical devices, and market access — including years at Zeiss and then the start-up Beyeonics. The conversation covers what it actually means to be the connective tissue in a field driven by innovation, and what happens at a major meeting like AAO when you're not tied to a booth or a session.

Hosts: John Kitchens, MD, Scott Krzywonos

Topics Covered

Bob Jahr on the Lytenava Launch

The road to approval: Outlook received three complete response letters before winning a formal dispute resolution appeal; approval granted July 24, 2026, without any additional safety, efficacy, or post-marketing commitments — a rare outcome for an appeal.

What a CRL is: the FDA's formal notice that a submitted package does not meet approval criteria; may cite data interpretation, endpoint alignment, safety, efficacy, or manufacturing issues. Triggers an opportunity for type A meetings with the FDA to seek clarity before resubmission.

Launch timeline: Lytenava will be in market channels by end of 2026; full commercial team and field force active January 2027. Q4 2026 will focus on early adopter engagement, payer conversations, and practice manager outreach.

Manufacturing: 100% US-based; drug product and drug supply split between Texas and San Diego; entire global supply produced domestically.

Commercial infrastructure: field reimbursement managers, key account managers, and a sales force are being built now; patient assistance programs and free product support confirmed; samples under evaluation based on community input.

Pricing: not yet announced but imminent; Outlook is threading a narrow needle between patient affordability, payer access, and practice economics. Bob emphasizes long-term pricing sustainability and predictability enabled by their own IP and permanent J code.

Compounded bevacizumab: Outlook's stated position is to bring a new option in, not take options away. Bob declined to speculate on regulatory action vis-a-vis compounding but confirmed it is not within Outlook's control.

Europe as a preview: approved in Germany, Austria, and UK in June 2025 for wet AMD; key learnings include listening to stakeholders before launch, identifying early adopters, and clearly differentiating Lytenava from biosimilars.

Miles Harper on Ophthalmology Consulting

Background: years at Zeiss in ophthalmology, followed by four years at the surgical startup Beyeonics; now an independent consultant focused on pre-commercial strategy and early market access for device and technology companies.

Core value proposition: helping companies understand the real-world market value of a product — not just whether it works, but how it fits into clinical workflows, who the actual end user is, and whether it solves a problem that physicians and technicians actually have.

Intraoperative OCT as a case study: a technology that has existed for roughly 10 years but whose clinical utility has lagged behind its promise — a useful example of innovation that hasn't yet found its footing in the OR workflow.

Conference strategy: value at major meetings like AAO comes from hallway conversations, random encounters, and informal relationship-building — not sessions or booths. Preparation begins months in advance by getting on calendars; the real work happens in real time on the floor.

Miles will return for a future episode focused on specific technologies that succeeded or struggled in the ophthalmology market.

Key Takeaways

Lytenava's US launch is on track for Q4 2026 customer engagement and full commercialization in January 2027; pricing announcement is imminent.

The formal dispute resolution process that led to Lytenava's approval is rare — fewer than 8% of appeals are granted, per Outlook President & CEO Bob Jahr — and Outlook did so without any additional data commitments.

Pricing will determine everything: Bob Jahr is clear that Outlook is thinking about affordability and sustainability, but the number itself has not yet been released.

In ophthalmology consulting, the most valuable conversations happen in the hallway, not the boardroom — and the best advisors help companies understand who actually uses their product and why.

Sponsors

This episode is made possible by Genentech, maker of Vabysmo (faricimab-svoa). Follow Vabysmo on LinkedIn to hear from leading experts on their real-world experience, and watch the Purple Chair series at Vabysmo-HCP.com.

Credits

Production & Marketing: Laura Brown | Business Operations: Liz Hogan

🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Breaking news: the US Food and Drug Administration approved Lytenava (bevacizumab-vikg, Outlook Therapeutics) on July 24, 2026 — making it the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the United States.

John Kitchens, MD, and Scott Krzywonos break down what this approval means in real-world terms: the upside for practices and patients, the unresolved questions around compounded bevacizumab, and what the pricing decision will ultimately determine. They also preview their upcoming interview with Bob Jahr, CEO of Outlook Therapeutics — one of his first since the approval.

Hosts: John Kitchens, MD, Scott Krzywonos

Topics Covered

The Lytenava Approval: What We Know

Lytenava (bevacizumab-vikg) approved July 24, 2026 for neovascular AMD; first and only FDA-approved ophthalmic formulation of bevacizumab; already approved in the Germany and UK (June 2025) for wet AMD.

Approval pathway: Outlook first submitted a BLA in 2022; received a complete response letter in August 2023; resubmitted February 2025; received a second CRL in December 2025; resubmitted June, 2026; approved July, 2026.

The upside: for the first time, retina specialists have access to a bevacizumab formulation developed specifically for intravitreal use — with validated manufacturing, FDA-approved labeling, and ongoing pharmacovigilance. A pre-filled syringe formulation eliminates the variability associated with compounding.

Launch timeline: Outlook anticipates a measured commercial launch by end of 2026; pricing not yet announced.

The Unresolved Questions

Compounded bevacizumab: once an FDA-approved ophthalmic bevacizumab exists, regulators may restrict compounding; compounding pharmacies may independently pull back given liability concerns. Access for non-wet AMD indications (eg, DME, CRVO, BRVO)— remains a critical concern.

Tiered therapy: compounded bevacizumab currently sits at the front of many insurer step therapy requirements due to its low cost. How Lytenava is priced will determine whether it inherits that position or disrupts it — and whether patients on fixed incomes retain access to affordable first-line therapy.

Not a biosimilar: Lytenava is an FDA-approved ophthalmic formulation of bevacizumab — not a biosimilar. This distinction matters for how it is classified under tiered therapy and step therapy protocols.

Preview: Bob Jahr, CEO of Outlook Therapeutics

John and Scott will speak with Bob Jahr, CEO of Outlook Therapeutics, in an upcoming episode — one of his first interviews since the approval. Topics will include launch timing, pricing strategy, support programs for practices and patients, and Outlook's position on compounded bevacizumab.

Key Takeaways

Lytenava is a genuine milestone — the first FDA-approved ophthalmic bevacizumab after more than two decades of off-label compounded use.

Everything hinges on pricing: responsible pricing could expand access and legitimize the category; aggressive pricing could restrict it.

Compounded bevacizumab's future is uncertain — regulatory and liability pressure could reduce access for patients using it for non-wet AMD indications.

The Bob Jahr interview is coming soon — subscribe to catch it as soon as it drops.

Credits

Production & Marketing: Laura Brown | Business Operations: Liz Hogan

🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Show Notes:

Guests: Devon Ghodasra, MD – Partner, Southeastern Retina Associates, Chattanooga, Tennessee

Vas Sadda, MD – Director, Artificial Intelligence & Imaging Research, Doheny Eye Institute; Professor of Ophthalmology, David Geffen School of Medicine at UCLA

Show Summary

Scott Krzywonos starts the show solo this week — John Kitchens, MD, is in the middle of a move from Kentucky to Colorado and will share more about his new practice in a future episode. But don’t worry: John is here for our two interviews.

Devon Ghodasra, MD, of Southeastern Retina Associates joins to share a detailed, practice-tested approach to biosimilar adoption — from building a physician committee and vetting products, to scripting patient conversations and navigating billing hiccups. This is Part 1 of a two-part biosimilar series; Part 2 will feature an oncologist whose specialty has nearly a decade of biosimilar experience to draw from.

SriniVas R. Sadda, MD — the world's most published author on ultra-widefield imaging — closes the episode in the Image of the Month segment. He showcases a 40-year-old patient with pathologic myopia and a peripheral detachment. Optos Silverstone RGB imaging and swept-source ultra-widefield OCT revealed a schisis detachment that had been difficult to appreciate on standard examination, ultimately changing the clinical management plan.

Hosts: John Kitchens, MD, and Scott Krzywonos

Topics Covered

Biosimilars in Retina Practice: A Practice-Tested Playbook (Devon Ghodasra, MD)

Pre-implementation: Southeastern Retina Associates formed a physician biosimilar committee to evaluate safety and efficacy data before adoption; pivotal trials for Byooviz were central to early confidence-building in ranibizumab biosimilars.

Implementation strategy: the practice adopted a unified, practice-wide switch to Cimerli on January 1, 2024 — a process Dr. Ghodasra calls an "insurance blizzard" timing mistake, but instructive nonetheless. Pavblu is (for now) the most commonly used agent across the practice.

Patient communication: brief, confident, focused scripting is key. Reassure first — is it safe, will it work as well? Avoid technical language; explain that it's made from living cells and can't be identical, but has been thoroughly evaluated by the FDA. Mention financial flexibility for the healthcare system if relevant. Loop back to reassurance at the end.

When costs go up: address the possibility proactively before patients see their EOB. Frame around financial flexibility and the value of having more treatment options — including supply chain resilience.

Handling pushback: rare when the science is explained clearly. Dr. Ghodasra's approach: "What I would be comfortable with for my own mother" tends to close the conversation.

Vetting biosimilars: beyond FDA approval, key factors include manufacturer reliability in biologics, dedicated retina support, copay assistance and patient programs, and willingness to engage with physicians and practices rather than exclusively with payers. Syringe characteristics and pre-filled vs. vial-drawn formulations also matter.

Billing pitfalls: new biosimilars launch with temporary J codes before permanent Q codes are assigned — claims denials and delayed payments are common. Getting your feet wet with a biosimilar that already has a permanent Q code is the safest first step.

Image of the Month: Peripheral Schisis Detachment (SriniVas R. Sadda, MD)

Case: 40-year-old male with pathologic myopia, lost to follow-up for several years; presented for routine follow-up.

RGB vs. RG imaging: side-by-side comparison shows how true-color RGB removes the green cast of traditional RG imaging, enabling better appreciation of color differences in pathology — particularly for inflammatory lesions, fibrosis, and white retinal changes. Especially valuable for trainees whose fundus examination experience sets the baseline for image interpretation.

Findings in this case: peripheral atrophy, tilted nerve, macular atrophic changes, pigmentary changes inferiorly, and a retinal detachment visible temporally — more apparent on RGB than RG.

Swept-source ultra-widefield OCT: confirmed a schisis detachment with an outer retinal break; vitreous still attached in this younger patient, likely contributing to the initial schesis. A deep staphyloma was also identified — relevant to surgical planning, as it increases the risk of primary vitrectomy failure and may favor a scleral buckle approach.

Fluorescein angiography: obtained to exclude other contributors to the detachment; revealed RPE staining inferiorly (chronicity) and retinal vessel staining temporally (newer involvement as schisis progressed).

Management: laser barricade per patient preference; patient declined more invasive intervention at this time.

Clinical pearl: ultra-widefield peripheral OCT can be placed anywhere the OptoMap image is obtained — making peripheral retinal OCT highly accessible even for less experienced imagers.

Key Takeaways

Biosimilar adoption requires upfront investment in physician education, patient scripting, and billing preparation — but the payoff in financial flexibility and patient access is real.

Vetting biosimilars goes beyond safety data: manufacturer commitment to ophthalmology, patient support programs, and payer engagement strategies all matter when choosing which product to stock.

True-color RGB ultra-widefield imaging changes what you can see — particularly for inflammatory disease, fibrosis, and subtle color-based pathology — and may be especially valuable for trainees.

Swept-source ultra-widefield OCT can define the limits of peripheral detachments that are difficult to appreciate by color imaging alone, and can change surgical planning.

Watch RetinUp on YouTube

If you want to see the visuals associated with RetinUp, or just prefer YouTube as a podcast streamer, find us on YouTube: youtube.com/@RetinUpPodcast

Sponsors

This episode is made possible by Genentech, maker of Vabysmo® (faricimab-svoa). Watch the Purple Chair series at Vabysmo-HCP.com.

The images featured in this episode were captured using the Optos Silverstone RGB. Learn more about Silverstone RGB at Optos.com/products/silverstone.

Credits

Production & Marketing: Laura Brown | Business Operations: Liz Hogan

🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Jorge Fortun, MD, of Bascom Palmer Eye Institute joins John Kitchens, MD, and Scott Krzywonos for a wide-ranging conversation on the art of retina practice, from the unique challenges of seeing highly educated, high-expectation patients in Palm Beach Gardens, to the patient communication strategies he relies on every day. He shares the analogies he uses to explain DME, GA, and AREDS vitamins, discusses the realities of seeing celebrities and titans of industry, and reflects on how to have honest conversations when medicine has nothing more to offer.

The episode also covers the ongoing threat of unregulated stem cell clinics in Florida, how patients are arriving more prepared — and sometimes better informed about clinical trials than the physicians themselves — and what Jorge is most excited about in the retina pipeline, with a specific focus on TKIs. He closes with a preview of his role at ASRS 2026.

Hosts: John Kitchens, MD, Scott Krzywonos

Topics Covered

Practicing Retina in Palm Beach Gardens

• Patient demographics: wealthy, highly educated, internationally diverse; often arriving for a fourth, fifth, or sixth opinion
• Discretion and VIP accommodations for high-profile patients; privacy protocols in place for political figures and celebrities
• Managing expectations: Jorge's core principle is that disappointment comes from expectations and reality not aligning — and his job is to be thorough and honest without inspiring false hope
• When medicine runs out of answers: the importance of acknowledging the human being beyond the OCT, including referrals for low vision and mental health support

Patient Communication: Analogies & Metaphors

• DME and dialysis: explaining lifelong treatment burden to diabetic patients by comparing intravitreal injections to dialysis — "dialysis for your retina, but much better"
• GA and complement inhibitors: the car and the cliff — pressing the brakes matters most when you're far from the edge; if the car is moving slowly, the calculus changes
• AREDS vitamins: explaining why a well-studied, clinical trial-backed formula is meaningfully different from the supplements his Palm Beach patients are already taking
• The risk of "retina speak": even physician colleagues outside ophthalmology often don't understand what retina specialists are talking about; plain language and analogies are essential

Stem Cell Clinics in Florida

• Jorge’s colleague Tom Albini, MD, has documented and testified before Congress on unregulated "stem cell" clinics in Florida that caused serious complications in multiple patients
• Florida's concentration of elderly, wealthy patients seeking solutions makes it a particularly fertile environment for these clinics

The Retina Pipeline: TKIs & GA

• Jorge's near-term excitement: TKIs as sustained-release agents offering dual mechanistic VEGF inhibition — intracellular and extracellular — for wet AMD, DME, and diabetic retinopathy
• GA therapies: two FDA-approved complement inhibitors are available but generate significant chair time; oral and subcutaneous agents in the pipeline are promising; stem cell approaches remain supportive, not restorative
• Clinical trial conversations: wealthy, internationally connected patients often arrive with knowledge of trials Jorge hasn't heard of; honesty about what he doesn't know is his default

ASRS 2026 Preview

• Jorge helped organize Retina Surgery Around the Globe at the opening of ASRS 2026 — Wednesday session, first day of the meeting
• Concept: four teams of early-career retina surgeons from around the world present surgical videos, mentored by Aleksandra Rachitskaya, MD; Nina Berrocal, MD; Paul Chan, MD, MBA; and Jorge himself
• Mission: promote young surgeons and showcase international surgical technique and innovation; inspired by the belief that US retina surgeons learn disproportionately little from their international peers

Key Takeaways

• Patient communication in a high-expectation, highly educated practice demands clear analogies, radical honesty, and the humility to say "I don't know" — without losing the patient's trust.
• TKIs represent the most tangible near-term advance in treatment burden reduction; GA management remains largely a counseling and expectation-management challenge.
• Retina Surgery Around the Globe at ASRS 2026 is a must-see for anyone interested in international surgical technique and supporting the next generation of retina surgeons.

Sponsors

This episode is sponsored by Genentech. Watch their Purple Chair Series at Vabysmo-hcp.com.

This episode is sponsored by Ocular Therapeutix, a biopharmaceutical company working to redefine the retina experience across drug development, treatment, and outcomes. Learn more at OCUTX.com.

Credits

Production & Marketing: Laura Brown | Business Operations: Liz Hogan

🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Guests: Hunter Cherwek, MD – Vice President, Clinical Services & Technologies, Orbis International

Frank Brodie, MD, MBA – Assistant Professor of Ophthalmology, UCSF; Co-Founder, Long Bridge Medical

Show Summary

Hunter Cherwek, MD, Vice President of Clinical Services & Technologies at Orbis International, joins John and Scott to discuss how Orbis has evolved from a single Flying Eye Hospital into a global force spanning AI-powered diagnostics, distance learning, drug distribution, and children's eye care.

Frank Brodie, MD, MBA, co-inventor of LensOne, then joins to explain what the prosthetic capsular bag solves, how it works, and where it's headed — including the upcoming GOLDEN GATE pivotal trial launching this fall.

Hosts: John Kitchens, MD, Scott Krzywonos

Topics Covered

Hunter Cherwek, MD, on Orbis International

• Orbis founded 1982; the Flying Eye Hospital — a US-accredited hospital aboard an MD-10 aircraft — now represents ~15% of Orbis activity
• CyberSight: the world's largest freely available ophthalmic distance learning platform; recently hosted a live lecture watched by 127 countries simultaneously; originated as a pediatric mentorship program by Eugene Helveston, MD
• Trachoma eradication: Orbis distributes 200–250 million doses of azithromycin annually in Ethiopia; Hunter projects eradication within 10 years
• AI and diabetic retinopathy: RAIDERS trial in Rwanda (conducted entirely during COVID, fully remote) showed a 40% improvement in referral rates to medical retina; B-PRODUCTIVE study in Bangladesh improved retina clinic procedural volume by 248%
• Oculomics: Orbis is now using retinal AI biomarkers to detect systemic disease, positioning the eye as a window into neurovascular health
• 450+ volunteers from 40+ countries; the associate program allows residents to observe (not operate) and build global health foundations early in training
• How to get involved: orbis.org — volunteer tab at the top of the site; particular need for ROP, inherited retinal disease, and pediatric retina specialists

Frank Brodie, MD, MBA, on LensOne

• The problem: secondary IOL fixation (Yamane, four-point fixation, glued IOL) has a 14% re-operation rate per a large IRIS Registry study; no FDA-approved solution currently exists beyond ACIOL, which fewer than 10% of surgeons use
• LensOne: a three-point fixated prosthetic capsular bag made by Long Bridge Medical; accommodates virtually any IOL type including toric and multifocal; injected through standard cannula incisions in roughly three minutes
• First-in-human trial: 15 patients in Sydney, Australia; 100% successful implantation; no conjunctival erosion or IOL dislocation; published in Ophthalmology (AAO journal) with surgical videos available online
• GOLDEN GATE trial: US pivotal study; ~12 sites; 110–130 patients; launching fall 2026; market entry targeted for late 2028–early 2029
• Training: bench-top only (model eyes and ex vivo porcine); no live animal training required; most steps are intuitive for retina surgeons already familiar with pars plana approaches
• More information and surgical animations: longbridgemedical.com

Key Takeaways

• Orbis has evolved far beyond the Flying Eye Hospital — it is now a global AI, telemedicine, and drug distribution organization reaching the world's most underserved patients, and retina specialists can plug in at any career stage.
• LensOne addresses a real and underappreciated problem: secondary IOL surgery is technically demanding, legally risky, financially penalized, and currently without an FDA-approved solution beyond ACIOL.
• The GOLDEN GATE trial launches this fall; surgeons interested in participating should visit longbridgemedical.com.

Sponsors

Watch the Purple Chair series at Vabysmo-HCP.com.

Learn more about Unity VCS at UnityVCS.com.

Credits

Production & Marketing: Laura Brown | Head of Production: Liz Hogan

🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Guests: John B. Miller, MD – Associate Professor of Ophthalmology, Harvard Medical School; Director of Retinal Imaging; Associate Fellowship Director, Vitreoretinal Surgery, Mass Eye and Ear

Show Summary

John Kitchens, MD, opens with a recap of the inaugural Kiawah Eye Retina meeting, which used a case-based, panel-driven format and drew 80 retina specialists. It left him hoping for an invitation back next year.

John and Scott then turn to two news stories. First: Outlook Therapeutics won its formal dispute resolution appeal with the FDA and resubmitted its BLA for ONS-5010 in June. John and Scott unpack what an FDA-approved ophthalmic bevacizumab would mean for practices, patients, and the future of compounded bevacizumab — and why everything hinges on how Outlook chooses to price it.

John B. Miller, MD, joins to preview the 16th Annual Mass Eye and Ear Vitrectomy Course (July 10-11, 2026), a boot camp-style introduction to vitreoretinal surgery for first-year fellows that takes place in the actual Mass Eye and Ear ORs.

The Vitreoretinal View closes with a deep dive into Encelto (Neurotech Pharmaceuticals), the first FDA-approved treatment for MacTel2, covering patient selection, the reimbursement landscape, how AI may help identify disease earlier, and why 200 implants in the first year of launch represents a genuine milestone for a rare disease therapy.

Hosts: John Kitchens, MD; Scott Krzywonos

Topics Covered

Kiawah Eye Retina Meeting Recap

• First-ever retina track at Kiawah Eye; co-chaired by John Kitchens, MD, and LejlaVajzovic, MD; organized by Rishi Singh, MD
• Entirely case-based format with panels, audience participation, and fellow/resident presentations
• ~80 attendees, strong industry presence; John anticipates the meeting doubles in size next year

Outlook Therapeutics

• Outlook won its formal dispute resolution appeal May 26, 2026; FDA concluded substantial evidence of effectiveness for nAMD; BLA resubmitted June 1, 2026 as a Class 1 review (60-day PDUFA decision window)
• If approved, ONS-5010 would be the first FDA-approved ophthalmic formulation of bevacizumab
• The double-edged sword: approval validates the need for a reliably manufactured, ocular-grade bevacizumab; published data documents significant variability in compounded Avastin concentration
• Risk to access: once an approved drug exists, FDA may restrict compounding; if priced too high, patients without insurance could lose access to their most affordable option

Mass Eye and Ear Vitrectomy Course with John B. Miller, MD

• 16th annual course; July 10-11, 2026; free of charge; held at Mass Eye and Ear
• Designed for first-year retina fellows; ~60 first-year fellows typically attend out of ~85 nationwide — effectively the entire incoming class
• Day 1: lectures and case panels featuring faculty including Harry Flynn, MD; Stanley Chang, MD; and Steve Charles, MD
• Day 2: wet lab in the actual Mass Eye and Ear ORs; fellows rotate through three one-hour stations covering scleral buckling, vitrectomy, and membrane peeling; near 1:1 faculty-to-fellow ratio; injection technique stations also incorporated
• Registration: course page hosted by MCPI; late registrations accepted
• Register at this link: https://mcpi.cventevents.com/event/mee2026/summary

Vitreoretinal View: Encelto for MacTel2

• MacTel2: now understood as a neurodegenerative, not primarily vascular, condition; bilateral; often presents in the 30s-50s; affects reading speed and juxtafoveal vision even when distance acuity is preserved
• Encelto (Neurotech Pharmaceuticals): CNTF-producing cell implant sutured inferotemporally via pars plana; FDA-approved March 2025; potentially lifelong — viable CNTF-producing cells confirmed 14 years post-implantation
• 200 implants in first year of launch: hosts characterize this as a strong result given the $250,000 price, limited patient population, and modest per-procedure margin for surgeons
• Reimbursement pathways: buy-and-bill (high risk of clawback) vs. specialty pharmacy route (no drug margin, but surgical fee intact); insurance approvals still maturing
• Patient selection: John identifies two groups — those stable and needing reassurance vs. those with meaningful functional decline who are the most motivated candidates
• AI and early detection: John describes uploading de-identified OCTs that appeared normal to Claude AI, which flagged subtle early MacTel characteristics — raising the possibility that AI-assisted screening could identify subclinical disease earlier and improve treatment timing

Key Takeaways

• The path to approval for ONS-1050 is now clearer than ever — but its impact on patients will be determined by pricing, not the science.
• The Mass Eye and Ear Vitrectomy Course remains one of the most hands-on, surgically focused fellowships boot camps in the country; first-year fellows should register early.
• Encelto's first year in the real world reflects genuine surgeon commitment to a therapy that offers modest financial incentive but meaningful patient benefit.
• AI-assisted OCT interpretation may play a future role in identifying subclinical MacTel earlier — improving the window for intervention.

Sponsor Notes

Watch the Purple Chair series at Vabysmo-HCP.com

Credits Production & Marketing: Laura Brown | Business Operations: Liz Hogan

Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

John Kitchens, MD, joins from Kiawah Island for the inaugural Kiawah Eye Retina meeting as he and Scott Krzywonos break down two pressing policy stories: what the GLOBE Project actually means for retina practices, and what the FDA's ongoing leadership vacuum could mean for drug approvals and smaller companies with limited runway. Arshad M. Khanani, MD, MA, then previews Clinical Trials at the Summit (CTS), the invite-only meeting he founded to bring physicians, industry, and sponsors into open conversation. The episode closes with Image of the Month: Roger A. Goldberg, MD, MBA, walks through a MacTel Type 2 case using Optos Silverstone RGB ultra-widefield imaging, autofluorescence, and fluorescein angiography — including a post-operative image of an Encelto implant in situ.

Hosts: John Kitchens, MD, Scott Krzywonos

Guests: Arshad M. Khanani, MD, MA – Managing Partner, Director of Clinical Research & Director of Fellowship, Sierra Eye Associates; Clinical Professor, University of Nevada, Reno School of Medicine; Founder & Co-Chair, Clinical Trials at the Summit Roger A. Goldberg, MD, MBA – Bay Area Retina Associates

Topics Covered

The GLOBE Project

• CMS Medicare drug pricing demonstration affecting ~25% of practices, selected geographically at random; launching September or October 2026
• Mechanism: pharma companies owe a rebate to the government based on lowest prices paid in comparable countries — but after ASP is established; practice-level reimbursement is not expected to change
• All details subject to change under the current policy environment

FDA Leadership Void

• Commissioner Marty Makary departed May 12, 2026; Kyle Diamantis appointed acting leader; all three top FDA positions now filled by acting officials (210-day limit under federal law)
• Broader HHS gaps: no Senate-confirmed surgeon general, NIH head doubling as acting CDC director
• Phase 3 programs already underway are relatively insulated; early-stage companies face the greatest risk from delays and unpredictability
• Replimune precedent: FDA approved a trial design, then denied approval after positive data — a cautionary example for industry
• Hosts forecast 2027 as a difficult year for FDA approvals

Clinical Trials at the Summit (Arshad M. Khanani, MD, MA)

• Founded 2021; first live meeting 2022; now in its sixth year; held June 13, 2026 in Las Vegas
• Bridges sponsors, sites, CROs, and physicians in a format where industry and academic physicians can speak openly — unlike traditional CME meetings
• Small and invite-only by design; global faculty across career stages; practicing physicians involved in trials may request an invitation at ctsretina.org
• 2026 highlights: fireside chats with Wiley Chambers (former FDA ophthalmology head) and Pravin Dugel, MD; first-time Phase 3 late-breaking data; Wall Street and CEO panels; video competition

Image of the Month: MacTel Type 2 & Encelto (Roger A. Goldberg, MD, MBA)

• Multimodal imaging case using Optos Silverstone RGB: ultra-widefield color, autofluorescence, and fluorescein angiography demonstrate classic MacTel findings — luteal pigment disruption, right-angle vessel branching, and parafoveal temporal leakage
• SLO technology enables quality imaging through media opacities and small pupils
• Second case: post-op ultra-widefield image of Encelto (revakinagene taroretcel-lwey, Neurotech Pharmaceuticals) CNTF implant positioned inferotemporally; SLO extended depth of field keeps both implant and posterior pole in focus
• Clinical pearl: ultra-widefield imaging contextualizes disease extent for patients — only 2% of the retina affected, but in the wrong location

Key Takeaways

• The GLOBE Project is not expected to affect practice-level reimbursement; the financial adjustment falls on manufacturers.
• FDA instability poses the greatest risk to early-stage companies; 2027 may be a difficult year for the retina pipeline.
• CTS is a must-attend for anyone involved in clinical trials — intimate format, global faculty, and first-time data every year.
• Encelto is the first approved therapy to slow MacTel progression; ultra-widefield imaging is a key tool for diagnosis, monitoring, and patient education.

Sponsors

RetinUp is an editorially independent podcast supported with advertising.

This episode is sponsored by Astellas. Learn more at Astellas.com. This episode is sponsored by Genentech, maker of Vabysmo® (faricimab-svoa). Watch the Purple Chair series at Vabysmo-HCP.com. The images in this episode were captured using the Optos Silverstone RGB. Learn more at Optos.com/products/silverstone.

Credits Production & Marketing: Laura Brown | Business Operations: Liz Hogan

🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Guests: Marci English, MPH – Senior Vice President, Biopharma and Ophthalmology Development, Astellas Pharma | Erin Kimbrel, PhD – President, Astellas Institute for Regenerative Medicine (AIRM); Head of Cell and Gene Therapy Research, Astellas Pharma | Murtaza Adam, MD – Chair of Clinical Research, Colorado Retina Associates

Hosts: John Kitchens, MD, Scott Krzywonos

Show Summary

Recorded on the final day of ARVO 2026 in Denver, John Kitchens, MD, invites Marci English, MPH, and Erin Kimbrel, PhD, from Astellas to review some of the most significant cell therapy data to emerge in retina in recent years: the phase 1b interim results for ASP7317, an investigational RPE cell therapy that showed functional visual acuity gains in patients with advanced GA. The conversation covers what made earlier cell therapies fail, what's different now, the path to a registration trial, and two additional pipeline programs: ASP2767 (a gene therapy for glaucoma) and ASP2020 (an immune-evasive RPE cell therapy for Stargardt disease).

The Vitreoretinal View segment features Moo Adam, MD, who has been performing IV-free vitreoretinal surgery since 2018, now accounting for roughly 70% of his cases. He breaks down patient selection, practical logistics, and why the approach could serve as a bridge to office-based surgery. John and Scott then cover the realities of office-based surgery and speculate what needs to change for retina surgeons to embrace office-based surgery.

Hosts: John Kitchens, MD, Scott Krzywonos

Topics Covered

ASP7317 Phase 1b Interim Results

• ASP7317: investigational RPE cell therapy derived from human embryonic stem cells, delivered via subretinal transplantation in advanced GA secondary to AMD
• Three dose cohorts with severity stratification; BCVA improvements observed in multiple patients, including gains of 2 lines
• GA lesion area stabilized in treated eyes; only 1 month of immunosuppression required
• Mechanism: likely a combination of cell replacement, phagocytic debris clearance, and trophic factor secretion
• Why earlier RPE transplantation attempts failed: engraftment and immune rejection; advances in differentiation technique and surgical delivery have changed the picture

Pipeline & Path Forward

• Astellas plans to engage regulators in the coming months with the goal of moving directly to Phase 3; functional BCVA endpoints expected to be central to the registrational design
• Complement inhibitors and ASP7317 seen as complementary across the GA spectrum: slowing progression in early disease, potentially restoring function in advanced disease
• ASP2020: iPS-derived RPE cell therapy for Stargardt disease, Phase 1 expected in 2026; EVOLVE natural history study ongoing
• ASP2767: AAV gene therapy for neuroprotection of retinal ganglion cells in glaucoma; IND filing anticipated shortly

Vitreoretinal View: IV-Free Surgery (Moo Adam, MD)

• Oral sedation plus sub-Tenon's block replaces IV anesthesia in approximately 70% of Dr. Adam's cases; in practice since 2018 with published safety data
• Patient benefits: no fasting, no anesthesiologist copay, no GLP-1 or anticoagulation concerns; appropriate patients can drive themselves home
• Patient selection is key, and active patient communication during surgery is essential

Office-based Surgery in 2026

• Office-based surgery context: the financial model isn't there yet; no facility fee reimbursement in the office setting, and organized ophthalmology advocacy has stalled

Key Takeaways

• ASP7317 Phase 1b data showed cell-based therapy led to functional BCVA gains in advanced GA.
• Astellas views complement inhibitors and ASP7317 as complementary tools, not competitors, across the GA disease spectrum.
• IV-free vitreoretinal surgery is practical, patient-friendly, and already in routine use — but the path to office-based surgery still requires a reimbursement solution.

Credits Production & Marketing: Laura Brown | Business Operations: Liz Hogan

Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Guests: Clorinda Walley – President & CEO, Good Days | Prof. Paulo Stanga – Founder & Chief Medical Officer, The Retina Clinic London; Professor of Ophthalmology, UCL Institute of Ophthalmology

Show Summary

This episode of RetinUp pulls back the curtain on Good Days, one of the most important — and least understood — resources in retina practice. Clorinda Walley, Good Days President & CEO, joins John and Scott to explain how the organization works, how it's funded, who qualifies, and what retina specialists can do to help sustain it. The conversation covers everything from the mechanics of fund allocation to the policy threats currently on Good Days's radar.

The episode then moves to the inaugural Image of the Month, featuring Prof. Paulo Stanga, who presents a case of papillophlebitis initially referred as a branch retinal vein occlusion. The case demonstrates how ultra-widefield RGB imaging with the Optos Silverstone RGB changed the clinical picture before the patient ever entered the exam room.

Hosts: John Kitchens, MD, and Scott Krzywonos

Topics Covered

Good Days in 2026 (Clorinda Walley)

• What is Good Days?
• Types of assistance (copay, premium, and travel support across multiple disease categories) and who is eligible for support
• Funding sources for Good Days
• How retinal vascular disease assistance operates separately from GA assistance
• What happens when a program is funded—and when funding runs out
• Good Days’ advocacy in DC and beyond
• Getting your patients enrolled in Good Days

Image of the Month: Papillophlebitis (Prof. Paulo Stanga)

• Case presentation: patient referred for a clinical trial with presumed branch retinal vein occlusion
• Ultra-widefield RGB imaging with the Optos Silverstone upon referral
• Final diagnosis: papillophlebitis
• Clinical workflow advantages of pre-visit imaging

Key Takeaways

• Good Days is a critical safety net for Medicare patients who cannot afford their retinal treatments, but its programs depend entirely on ongoing donations — funding can close without warning.
• Retina specialists can directly support Good Days by getting on the notification list, posting donation signage, and advocating with pharma partners for continued funding.
• Retina practice as we know it is supported by Good Days—but Good Days itself is only around as long as their donation base shows up.
• Ultra-widefield imaging captured early in an appointment changes clinical workflow: Prof. Stanga's case demonstrates that RGB imaging can redirect a diagnosis before the physician enters the room.
• True-color RGB ultra-widefield imaging with swept-source OCT provides a more complete picture of the retina than two-channel systems, particularly at the vitreoretinal interface and in patients with media opacity.

Sponsors

RetinUp is an editorially independent podcast supported with advertising.

This episode is sponsored by Ocular Therapeutix. Learn more at OCUTX.com.

This episode is sponsored by Genentech, maker of Vabysmo (faricimab-svoa). Watch the Purple Chair series at Vabysmo-HCP.com.

The images featured in this episode were captured using the Optos Silverstone RGB. Learn more about Silverstone RGB at Optos.com/products/silverstone.

Credits Production & Marketing: Laura Brown | Business Operations: Liz Hogan

Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Show Summary

This episode of RetinUp opens with a timely policy discussion between the hosts about proposed Medicare and Medicaid funding cuts, exploring what they could mean for retina practices and their most vulnerable patients.

The Vitreoretinal View segment features John Kitchens, MD, sharing his decade-long experience with heads-up 3D visualization. He reviews what makes it transformative for training and surgical outcomes, why widespread adoption has been slower than expected, and what might finally tip the scales.

In the main interview, Stanford's Darius Moshfeghi, MD, joins Scott and John to break down the SOL-1 Phase 3 superiority study on Axpaxli (OTX-TKI), Ocular Therapeutix's investigational bioresorbable intravitreal hydrogel incorporating axitinib. He discusses his unique role as an independent rescue monitor, explains the study's novel design, unpacks what the superiority outcome over aflibercept actually means for clinical practice, and previews what the SOL-R study may tell us next.

Hosts: John Kitchens, MD, Scott Krzywonos

Guests: Darius Moshfeghi, MD – Chief, Retina Division; Professor, Byers Eye Institute, Stanford University School of Medicine

Topics Covered

SOL-1 Study: Design, Findings & Context (Darius Moshfeghi, MD)

• The independent rescue monitor role: what it is, how it worked, and why it was created for SOL-1
• SOL-1’s study design, superiority outcome, and floaters data (and why they were not clinically concerning)
• Superiority vs. non-inferiority: implications for labeling, step therapy avoidance, and physician adoption
• How retina specialists could integrate Axpaxli into their practice protocols
• How SOL-R differs from SOL-1, and what SOL-R might show us

Vitreoretinal View: Heads-Up 3D Visualization

• Origins of heads-up 3D: TruVision and Alcon NGenuity
• Zeiss and Heidelberg heads-up visualization systems
• Why John adopted NGenuity early and continues to use it
• Key benefits: surgical video quality, fellow training, and real-time coaching
• Cost considerations and other reasons why adoption has remained low
• The anterior segment opportunity: how cataract surgery economics may drive broader uptake

Medicare & Managed Care Policy Concerns

• Proposed $200 billion in federal budget cuts and the potential impact on Medicare and Medicaid
• Risk of increased step therapy, Avastin-first policies, and tiered drug coverage
• Access-to-care concerns for Medicaid patients, particularly at academic medical centers
• The difference between traditional Medicare and managed Medicare (Medicare Advantage)
• Historical context: past Congressional threats to Medicare reimbursement and how they've played out

Key Takeaways

• The independent rescue monitor role pioneered in SOL-1 reflects a novel, collaborative approach to adjudicating vision-threatening events in clinical trials.
• Physicians will likely adapt AXPAXLI into existing treat-and-extend protocols; SOL-R's more traditional design may generate data that resonates more directly with clinical practice.
• SOL-1 is the first superiority study in retina/ophthalmology, demonstrating that a single injection of Axpaxli (Ocular Therapeutix) outperforms aflibercept 2mg (Regeneron) on vision maintenance — with durability extending well beyond current approved dosing intervals.
• Heads-up 3D visualization offers meaningful advantages for surgical training and video quality, but high costs for integrated systems and declining surgery center reimbursements continue to limit adoption.
• Proposed federal budget cuts to Medicare and Medicaid represent a real threat to retina practices and patient access, particularly for drug coverage and underserved populations.

Credits Production & Marketing: Laura Brown | Business Operations: Liz Hogan

This episode of RetinUp is a special deep dive into the Vit-Buckle Society (VBS), tracing its origins and previewing what’s ahead for the 2026 meeting.

In the first segment, Ross Lakhanpal, MD, shares the founding story of VBS — from informal dinner discussions among fellows to one of the most distinctive and influential meetings in retina. What began as an effort to preserve surgical retina education has evolved into a meeting known for its creativity, honesty, and strong sense of community.

The episode then shifts to Aleksandra Ratchitskaya, MD, who outlines the agenda and structure of the 2026 VBS meeting, including expanded programming for trainees, new educational tracks, and the continued emphasis on open discussion and real-world clinical challenges.

Across both conversations, a consistent theme emerges: VBS succeeds because it prioritizes authenticity, collaboration, and the full experience of being a retina specialist — not just the science.

Hosts:

John Kitchens, MD

Scott Krzywonos

Guests:

Ross Lakhanpal, MD, FACS – Founding Member, Vit-Buckle Society (VBS); Retina Care Center (Maryland)

Aleksandra Ratchitskaya, MD, – President, Vit-Buckle Society (VBS)

• Origins in 2004–2006 among fellows seeking more surgical retina focus
• Early dinner meetings piggybacking on major conferences (ASRS, AAO)
• Initial industry support from Bausch + Lomb and later Alcon
• The role of key mentors including Timothy Murray, MD, and Harry Flynn, MD,
• Transition from informal gatherings to a standalone national meeting
• Early challenges with organization, funding, and defining a clear vision

• Introduction of debates, live surgery, and unconventional formats
• The importance of creativity, energy, and peer-driven programming
• Balancing innovation with professionalism as the meeting grew
• The role of medical conference planners (MCPI) in scaling the event
• How VBS differentiated itself from traditional, science-heavy meetings

• Decision to hand leadership to the next generation
• Evolution of programming under new leadership
• Increased focus on year-round education, social media, and engagement
• Current leadership structure and succession planning
• Why maintaining a strong culture and relationships is critical to continuity

• Expanded Thursday programming for fellows, trainees, and early-career specialists
• “VBS Silver” sessions for more experienced physicians
• Fellows Forum-style competitions, including surgical video presentations
• Awards, including Lifetime Achievement and Mentorship recognition
• Dedicated sessions on practice management, advocacy, and wellness

• Surgical case discussions focused on complications and real-world challenges
• Debates on controversial clinical and professional topics
• A strong emphasis on honesty and open dialogue
• Social programming built around the Alice in Wonderland theme
• Networking that reflects the collaborative, peer-driven culture of VBS

• VBS was founded to address a gap in surgical retina education and has grown into a broader platform for professional development.
• The meeting’s success is rooted in its culture of openness, creativity, and peer collaboration.
• Leadership transition to younger physicians has strengthened the organization and expanded its reach.
• VBS continues to stand out by addressing the full scope of retina practice, including clinical, personal, and professional challenges.

Production & Marketing: Laura Brown

Business Operations: Liz Hogan

Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

In this breaking news episode, John Kitchens, MD, and Scott Krzywonos react to the announcement that Biogen will acquire Apellis Pharmaceuticals for $5.6 billion, an approximately 8x revenue multiple driven largely by Syfovre (pegcetacoplan), which accounts for the majority of Apellis’ srevenue.

The discussion focuses on what this acquisition could mean for the future of geographic atrophy (GA) treatment, including concerns around strategic priorities, industry support programs, and whether Biogen will maintain Apellis’ current momentum in retina.

This acquisition has the potential to reshape the geographic atrophy landscape — but its success will depend on whether Biogen maintains Apellis’ clinical focus, physician relationships, and commitment to innovation in retina.

Hosts:

John Kitchens, MD

Scott Krzywonos

Listen now at RetinUp.com or wherever you get your podcasts.

This episode of RetinUp combines clinical innovation and device engineering, starting with a discussion on photobiomodulation (PBM) in age-related macular degeneration (AMD), followed by a deep dive into the future of ophthalmic laser technology.

First, Marion Munk, MD, shares her extensive real-world experience using the Valeda Light Delivery System (Alcon) for PBM, including patient selection, treatment protocols, and functional outcomes. With over 300 patients treated, she provides one of the most comprehensive perspectives currently available on how PBM is being implemented in clinical practice.

The episode then shifts to Oliver Hvidt, co-founder and CEO of Norlase, who explains how his training in economics led him to develop a next-generation, portable laser systems. The conversation explores how engineering, economics, and workflow design intersect to improve efficiency in retina practices.

The episode opens with a brief discussion on optometric scope expansion in Kansas, where John explains that fears surrounding scope changes may be overblown.

Hosts:

John Kitchens, MD

Scott Krzywonos

Guests:

Marion Munk, MD – Medical Retina & Uveitis Specialist, Gutblick Group (Switzerland)

Oliver Hvidt – Co-Founder & CEO, Norlase

1. Kansas legislation expanding optometric procedural scope
2. Real-world experience from Kentucky following similar changes
3. Why expanded scope has had limited impact on retina practice
4. The evolving role of optometry as general ophthalmology declines

1. Differences between general “red light therapy” and medical PBM
2. The Valeda Light Delivery System and evidence from LIGHTSITE trials
3. Real-world outcomes from 300+ treated patients
4. Ideal patient profiles (drusen-predominant AMD, non–center-involving GA)
5. Reported benefits: improved dark adaptation, contrast, and daily function
6. ~50–60% of patients reporting subjective improvement
7. Challenges in correlating functional gains with OCT or structural changes
8. Implementation strategies: standardized imaging, AI-assisted analysis, and patient tracking
9. When to continue vs. discontinue treatment in non-responders

1. Founding story: from engineering collaboration to ophthalmic application
2. Redesigning laser architecture using semiconductor technology
3. Miniaturization and portability (headset-based indirect laser systems)
4. MEMS-based pattern scanning vs. traditional galvanometer systems
5. Designing equipment around workflow efficiency, not just performance
6. Addressing increasing patient volume with limited clinical resources
7. Funding challenges in a post-COVID, AI-dominated investment landscape
8. Future roadmap: software-driven upgrades and multi-specialty applications

1. Photobiomodulation is gaining traction, but patient selection and expectation-setting are critical.
2. Functional improvements in AMD may not always correlate with structural imaging.
3. Device innovation in retina is increasingly focused on efficiency, portability, and workflow integration.
4. The future of ophthalmic technology will depend as much on practice economics as clinical performance.

This episode includes a segment made possible with support from Alcon, featuring technologies like UNITY VCS designed to enhance surgical performance and efficiency.

Credits:

Production & Marketing: Laura Brown

Business Operations: Liz Hogan

Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Hosts:

John Kitchens, MD

Scott Krzywonos

In this special RetinUp Mailbag episode, John Kitchens and Scott Krzywonos answer listener questions from retina specialists around the country about three issues: cash-pay diversification, the future of emerging therapies in light of payer realities, and how practices can realistically adopt expensive new technology as reimbursements decline.

The conversation explores whether concierge retina models could emerge in certain markets, how insurers may respond to high-cost innovations like gene therapy and tyrosine kinase inhibitors, and what practical frameworks practices use when deciding whether to invest in new surgical or imaging equipment.

Throughout the episode, a central theme emerges: innovation in retina continues to accelerate, but reimbursement pressure is forcing practices to rethink business models, technology adoption, and long-term sustainability.

Topics Covered

Listener question from Jed Assam, MD (VRA Vision, Sioux Falls, South Dakota)

1. Whether concierge retina could work, and whether VIP-style care models might translate to retina practices
2. Potential cash-pay services such as photobiomodulation (PBM) therapy
3. Operational considerations for scheduling concierge visits separately from standard clinic flow
4. Geographic limitations for cash-pay models in smaller markets

Listener question from Deepak Sambhara, MD (Eye Clinic of Wisconsin, Wausau, Wisconsin)

1. How payers may respond to upcoming therapies such as tyrosine kinase inhibitors and gene therapy
2. The likelihood of step therapy policies changing
3. Pricing challenges for long-duration treatments
4. Economic implications of one-time gene therapy approaches

Listener question from Priya Vakharia, MD (Retina Vitreous Associates of Florida, Tampa, Florida)

1. How practices decide when to adopt new surgical technology
2. Cost pressures from declining surgical reimbursement
3. Evaluating investments in surgical and imaging equipment
4. The potential role of AI-driven analysis in improving efficiency and clinical decision-making

1. Concierge-style retina care may be viable in affluent metropolitan markets but remains niche.
2. Insurance economics will strongly influence how quickly new therapies reach patients.
3. Practices increasingly rely on ROI analysis and efficiency gains when deciding whether to adopt new technologies.
4. Artificial intelligence may help practices manage growing data complexity, though its financial model remains uncertain.

RetinUp listeners can submit questions by sending a voice memo to info@retinup.com, leaving a comment on YouTube, or connecting with John and Scott on LinkedIn.

Sign up for our newsletter at RetinUp.com.

Hosts:

John Kitchens, MD

Scott Krzywonos

Guests:

Thomas Stone, MD – Program Committee Chair, ASRS Business of Retina Meeting

Maria Berrocal, MD – CEO, Drs. Berrocal & Associates; Associate Professor, University of Puerto Rico

David Mandell, JD, MBA – Co-Founder & Partner, OJM Group

RetinUp brings together three distinct but interconnected conversations focused on the business, surgical innovation, and financial realities of retina practice.

First, Tom Stone joins the show to preview the upcoming ASRS Business of Retina Meeting in Houston (March 20–22). He outlines this year’s agenda, which covers staffing strategies, AI in practice operations, drug inventory management, coding updates, and a new full-day clinical trials workshop designed to help practices launch research programs from the ground up.

Next, in the Vitreoretinal View segment, Maria Berrocal discusses her experience using the Alcon UNITY VCS system, focusing on flow-based vitrectomy, 30,000 cpm performance, and the evolution of 27-gauge surgery. She also shares early observations comparing case times and complication rates versus legacy systems.

For the long-form interview, David Mandell of the OJM Group offers a structured framework for physician wealth management across career stages—covering early-career planning, mid-career tax strategy and asset protection, and retirement-phase portfolio positioning.

ASRS Business of Retina Meeting

1. The 2026 meeting agenda: staffing, AI implementation, and drug inventory strategy
2. Coding updates and compliance (including Modifier -25)
3. Launch of the Clinical Trials Workshop (capped at 80 participants, so register soon!)
4. Dedicated business curriculum for fellows

Vitreoretinal View – Surgical Innovation

1. Transition from vacuum-based to flow-based vitrectomy on Alcon UNITY VCS
2. 27-gauge adoption and surface vitrectomy precision
3. Reduced instrument frustrations

Physician Wealth Strategy

1. Why retina specialists are unique when it comes to wealth strategy
2. Early-career debt balancing, disability protection, and lifestyle creep
3. Mid-career tax optimization and liability protection
4. Retirement red-zone portfolio repositioning
5. Assessing private equity offers

1. The Business of Retina Meeting is will be in Houston March 20-22. Registration link below.
2. Flow-based vitrectomy may meaningfully refine 27-gauge surgery.
3. Financial discipline—not peak income—is what ultimately determines long-term security.

1. ASRS Business of Retina Meeting – Register Here
2. OJM Group – ojmgroup.com
3. Use the code RetinUp26 to get a free copy of the book Wealth Planning for the Modern Physician: Residency to Retirement at the OJM Bookstore.

Hosts:

John Kitchens, MD

Scott Krzywonos

Show Summary:

In this emergency episode of RetinUp, John and Scott break down the newly announced SOL-1 study data evaluating Axpaxli (Ocular Therapeutix) for the treatment of wet AMD.

The superiority trial compared a single Axpaxli injection to a single Eylea injection (after all eyes received a pair of monthly Eylea doses) in patients with wet AMD. The primary endpoint was the proportion of patients maintaining vision at 36 weeks (defined as losing fewer than 15 ETDRS letters).

Key findings include:

1. 74% of Axpaxli patients maintained vision at 36 weeks vs. 59% in the Eylea arm
2. Approximately 75% of Axpaxli patients required no rescue treatment through 36 weeks
3. Durable disease control extending 24–36 weeks, with some patients reaching 52 weeks

John and Scott discuss:

1. How the SOL-1 study design (FDA-aligned superiority endpoint) shaped the results
2. What this means for durability beyond traditional anti-VEGF therapies
3. Why the market reaction diverged from clinical enthusiasm
4. How to talk to your patients who hear about study data
5. What to expect next from the SOL-R study and a potential FDA submission

Why It Matters:

For the first time in years, retina specialists may be looking at a new mechanism of action — a tyrosine kinase inhibitor — with the potential to significantly extend treatment intervals after a single injection.

More detailed analysis and expert commentary coming soon on RetinUp.

Listen & Subscribe:

RetinUp.com | Apple Podcasts | Spotify | YouTube

Credits:

Production & Marketing: Laura Brown

Business Operations: Liz Hogan

Hosts:

John Kitchens, MD

Scott Krzywonos

Guest:

Thomas Albini, MD

Professor of Clinical Ophthalmology, Bascom Palmer Eye Institute

Course Co-Organizer, Angiogenesis, Exudation, and Degeneration Meeting

Show Summary:

In this episode, RetinUp offers pre-meeting coverage of the 2026 Angiogenesis, Exudation, and Degeneration meeting with one of its long-time course co-leaders, Thomas Albini, MD. John and Scott sit down with Tom to help listeners navigate what can be an overwhelming, marathon agenda—and to highlight the sessions most likely to shape retina care and research in the year ahead.

The conversation spans the rapid expansion of artificial intelligence in retina, early-phase geographic atrophy studies, durability strategies in wet AMD, and a packed slate of gene therapy and inherited retinal disease (IRD) updates. Tom also explains why the meeting remains fully virtual, how talks are selected, and why Angiogenesis continues to serve as a global preview of where retina research is heading.

Topics Covered:

1. Why the Angiogenesis meeting remains virtual—and how attendance has doubled
2. How to prepare for a one-day, 80+-talk retina marathon
3. The growing role of AI and machine learning in imaging and clinical trials
4. When AI may realistically impact everyday clinical practice
5. Early-phase geographic atrophy data and emerging systemic therapies
6. Oral and non-intravitreal treatment strategies—and their safety tradeoffs
7. Complement vs. non-complement targets in GA
8. Advances in wet AMD durability
9. What to watch in gene therapy, including delivery routes and inflammation risk
10. Inherited retinal disease sessions, including optogenetics and gene-agnostic approaches
11. Home OCT, imaging innovation, and AI-inferred fluorescein angiography
12. Landmark trials reaching their final chapters—and why they matter
13. How Angiogenesis fits alongside meetings like ASRS, AAO, and the Vit-Buckle Society

Key Quotes:

1. “You could say this is a lot of [AI] talks, but I think it's the tip of the iceberg. I would imagine it's going to be grow exponentially over the years.” — Thomas Albini, MD
2. “If there's any hour to not miss in this meeting, I've bookmarked that 2:45 to 3:45 hour because you literally get every single gene therapy talk in a single hour.” — John Kitchens, MD

Hosts:

John Kitchens, MD

Scott Krzywonos

Guest:

Elizabeth Cifers

Founder & Principal Consultant, Elizabeth Cifers Consulting

Show Summary:

In this episode, RetinUp introduces a new recurring segment, Vitreoretinal View, focused on surgical innovation and next-generation vitrectomy platforms. John breaks down where vitreoretinal surgery is headed, and comments on Alcon’s UNITY VCS system, flow-based vitrectomy, and his expectations for the next wave of surgical innovation.

But first, the conversation kicks off with a discussion of drug access and policy, as John and Scott revisit Outlook Therapeutics’ unsuccessful attempt to secure FDA approval for ONS-5010, an ophthalmic formulation of bevacizumab. They explain why continued access to compounded bevacizumab remains critical for affordability and patient choice.

In the second half, the hosts sit down with Elizabeth Cifers, one of the country’s leading ophthalmic coding and compliance experts. Elizabeth offers a clear-eyed assessment of Modifier -25 and Modifier -59, why enforcement has intensified, and how CMS’s shift from post-pay recovery to pre-pay, AI-driven audits is fundamentally changing compliance risk for retina practices heading into 2026. (Do you think your practice’s billing and coding staff would find this episode helpful? If so, share it with them—and tell them to send us feedback by emailing us at info@retinup.com.)

Topics Covered:

Why Outlook Therapeutics’ FDA rejection preserves access to compounded bevacizumab

Economic and regulatory risks of an FDA-approved bevacizumab alternative

Launch of the Vitreoretinal View surgical segment

Next-generation vitrectomy platforms and workflow efficiency

Alcon UNITY VCS vs. the legacy Constellation systems

Flow-based vs. Venturi-based vitrectomy

Surgical innovation amid declining reimbursement

What Modifier -25 actually requires — and common misconceptions

Proper and improper use of Modifier -59

Documentation gaps that trigger audits

CMS’s shift to AI-based anomaly detection

Pre-pay vs. post-pay audits and what practices should expect

How retina practices can prepare for changes in coding enforcement without overcorrecting

Key Quotes:

“The medicine is usually good. It’s the documentation that doesn’t support what’s being billed.” — Elizabeth Cifers

“With the algorithms CMS has now, [the question of whether you’ll be hit with an audit] is not an if — it’s a when.” — Elizabeth Cifers

“Compounded bevacizumab remains one of the most important access tools we have in retina.” — John Kitchens, MD

Guest Info:

Visit elizabethcconsulting.com to learn about how Elizabeth Cifers.

Sign up for her newsletter here, where Elizabeth shares actionable tips and strategies to help you run a more efficient, compliant, and profitable retina practice.

Hosts:

John Kitchens, MD

Scott Krzywonos

Guest:

Rishi P. Singh, MD

Chair, Department of Ophthalmology, Harvard Medical School

Chair, Department of Ophthalmology, Mass General Brigham

Show Summary:

In this episode, John and Scott break down two major developments affecting retina practices nationwide before welcoming one of the field’s most influential leaders. The discussion opens with the newly announced CMS GLOBE Model, a Medicare Part B demonstration project designed to lower drug prices through most-favored-nation pricing, and what it could mean for buy-and-bill retina practices. They then turn to the FDA’s expanded label for EYLEA HD, which now includes retinal vein occlusion and allows monthly dosing for certain patients.

In the second half, the hosts are joined by Rishi P. Singh, MD, newly appointed Chair of Ophthalmology at Harvard Medical School. Rishi reflects on stepping into leadership at one of the most storied institutions in medicine, his path from retina specialist to hospital CEO and back to academia, and how academic centers must adapt amid policy shifts, private equity pressure, and rapid technological change.

Topics Covered:

1. The CMS GLOBE Model and most-favored-nation drug pricing
2. Potential administrative and financial impact on practices in affected regions
3. The FDA’s expanded EYLEA HD label for RVO and monthly dosing
4. How label flexibility may change first-line treatment decisions
5. Insurance lag and real-world adoption challenges after label changes
6. Leadership transition at Mass Eye and Ear and Mass General Brigham
7. Balancing clinical care, research, and training in academic medicine
8. The role of academic centers in advocacy, innovation, and policy influence
9. Physician recruitment, culture, and servant leadership
10. Private equity’s role in modern ophthalmology
11. Industry collaboration, integrity, and long-term impact on patient care
12. The future of ophthalmology drug access under Part B and Part D reform

Key Quotes:

1. “The biggest issue for any of us is if buy-and-bill medicine disappears from our practices.” — Rishi P. Singh, MD
2. “We’ve been too focused on reactionary medicine and not enough on prevention.” — Rishi P. Singh, MD
3. “Anything that substantially disrupts drug pricing is going to have downstream consequences for practices.” — John Kitchens, MD

Credits:

Production & Marketing: Laura Brown

Business Operations: Liz Hogan

Listen and Subscribe:

🎧 RetinUp.com | Available on Apple Podcasts, Spotify, and YouTube

Hosts:

John Kitchens, MD

Scott Krzywonos

Guest:

Shane Dixon, Vice President of Vision, Strategic Advancement & Business Development, Cencora Specialty GPO

Show Summary:

In this episode, John and Scott continue their coverage of the Cencora Vision Exchange meeting with an in-depth conversation about the economic, policy, and operational forces reshaping retina practices. The discussion opens with key takeaways from the meeting’s opening sessions, including a deep dive into drug pricing policy, the downstream impact of federal legislation on how retina practices are reimbursed for care, and the coding and billing changes showcased at the Cencora Vision Exchange meeting.

John then sits down with Shane Dixon, VP at Cencora Specialty GPO, to unpack what a Group Purchasing Organization actually does—and why its role has become increasingly critical. Drawing on his experience as a physician assistant, former Regeneron launch leader for Eylea, practice executive, private equity operator, and now GPO executive, Shane offers a rare, 360-degree view of how drugs move from manufacturer to patient, how contracts are structured, and how practices can survive tightening margins.

Topics Covered:

1. Key takeaways from the Cencora Vision Exchange meeting
2. Federal drug pricing policy and “Most Favored Nation” pricing
3. How government policy is reshaping retina drug economics
4. Coding and billing risk, including increased scrutiny of Modifier 25
5. CMS’s use of AI for claim detection, audits, and recovery
6. Declining surgical reimbursement and its impact on access to care
7. The collapse of the Good Days patient assistance fund and what replaces it
8. What a Group Purchasing Organization (GPO) is and how it works
9. How Cencora’s GPO leverages scale, segmentation, and contracts
10. Differences between private practice and large aggregators

Key Quotes:

1. “The way we get paid for drugs is going to fundamentally change—and it’s going to change fast.” — John Kitchens, MD
2. “We’re not just doing contracts. We’re helping practices think strategically about how they operate.” — Shane Dixon
3. “Documentation isn’t optional anymore. ‘I didn’t know’ is not going to cut it.” — John Kitchens, MD

Credits:

Production & Marketing: Laura Brown

Business Operations: Liz Hogan

Listen and Subscribe:

RetinUp.com | Available on Apple Podcasts, Spotify, and YouTube

Hosts:

John Kitchens, MD; Scott Krzywonos

Guest:

Eric Besse, Vice President & General Manager, Besse Medical (a Cencora company)

Show Summary:

In this episode, Scott and John return from the Cencora Vision Exchange meeting in Dallas and sit down with Eric Besse, VP and General Manager of Besse Medical, to unpack the unseen infrastructure that keeps retina practices running. Eric shares how his family’s corner pharmacy grew into one of the most influential specialty distributors in the country and explains why drug distribution is far more than logistics — it’s practice support, financial stewardship, technology integration, and practice-level partnership.

The conversation spans everything from cold-chain handling and inventory management to sustainability and the future of practice support. For retina specialists, this is a rare, behind-the-curtain look at the systems that make allow retina practices to operate smoothly. 

Topics Covered:

• What the Cencora Vision Exchange meeting is and who attends
• The family origins of Besse Medical and its growth into a national distributor
• How Cencora and Besse Medical fit together
• Why distributors manage more than just shipping 
• Technology platforms such as CubixxMD and PODIS
• How drug distributors support retina workflows, billing, and compliance
• The importance of stable, long-tenured support teams for practices
• Cencora’s new recyclable, corrugated cold-chain packaging initiative

Key Quotes:

• “We don’t want to be viewed as a distributor that picks, packs, and ships product. We want to be more than that, and we push ourselves to be more than that.” — Eric Besse
• “If the soda fountain down the street puts two cherries on top, you put three. If they put three, you put four.” — Eric Besse, on his family’s philosophy of service
• “If I were starting a practice today, [Cencora] would be the first place I would turn to partner.” — John Kitchens, MD

Hosts:

John Kitchens, MD

Scott Krzywonos

Guest:

Alexander Gaffney, VP of Regulatory Policy & Intelligence, Agency IQ / POLITICO

Show Summary:

In this episode, Scott calls in from the Outer Banks to discuss two major clinical headlines before turning to federal policy. First up is the PRIMA retinal prosthesis, a wireless subretinal chip that helped patients with geographic atrophy regain partial reading vision. Then, Scott and John analyze the rapidly expanding — and often contradictory — body of research on GLP-1 receptor agonists and their links to retinal disease.

In the second half, they welcome Alexander Gaffney from POLITICO’s Agency IQ for a deep dive into how the ongoing government shutdown and widespread staff reductions are affecting the FDA’s ability to review and approve ophthalmic therapies. From PDUFA carry-over funds to workforce attrition, Alec explains why the true impact may not be the shutdown itself, but the backlog that follows.

Topics Covered:

• PRIMA retinal implant: wireless innovation and its surgical challenges
• The trade-off between functional vision gains and expanded atrophy area
• GLP-1 receptor agonists: mixed data on AMD, DR, and DME risk
• FDA shutdown implications for ophthalmic trials and approvals
• The reduction in force across FDA divisions and its effect on review capacity
• How new leadership and the National Priority Voucher Program aim to modernize the agency
• Why backlogs could extend into 2026 for gene therapy and TKI programs

Key Quotes:

• “I’m less worried about the shutdown itself — I’m worried about what happens afterward.” — Alexander Gaffney
• “You might not be able to read or drive, but that peripheral vision is what lets you move through the world. Losing more of that matters.” — John Kitchens, MD
• “We don’t always know what we’ve lost — how much faster certain drugs might have reached patients.” — Scott Krzywonos

Credits:

Production & Marketing: Laura Brown

Business Operations: Liz Hogan

Listen and Subscribe:

 RetinUp.com | Available on Apple Podcasts, Spotify, and YouTube

Hosts:

Scott Krzywonos

John Kitchens, MD

Show Summary:

In this episode, Scott and John pick up where they left off — talking about the American Academy of Ophthalmology (AAO) meeting and how innovation is reshaping the field. They explore their favorite AAO host cities, the atmosphere of this year’s meeting, and the under-the-radar conversations shaping the future of retina.

Scott shares insights from iCelerator, his favorite ophthalmology meeting, which highlights how technology, AI, and macroeconomic forces are influencing eye care. The two discuss “oculomics” — using retinal data to understand systemic diseases — and the potential of multimodal AI systems that combine imaging, genetics, and longitudinal data.

John then breaks down the next wave of therapies: gene therapy, tyrosine kinase inhibitors (TKIs), and how FDA study design changes could reshape how new drugs are approved. The discussion dives into superiority studies, the logic of targeting diabetic retinopathy (DR) instead of diabetic macular edema (DME), and what these shifts mean for patients and clinicians.

They wrap with a preview of the Cencora (formerly AmerisourceBergen) meeting — a behind-the-scenes look at the often-overlooked but crucial role drug distributors play in retina care.

Credits:

Production & Marketing: Laura Brown

Business Operations: Liz Hogan

Listen and Subscribe:

🎧 RetinUp.com | Available on Apple Podcasts, Spotify, and YouTube

In the debut episode of RetinUp, Drs. Scott Krzywonos and John Kitchens introduce their vision for the show—unfiltered conversations between retina specialists that capture the hallway and after-hours discussions rarely heard on stage.

They kick off by recapping highlights from the AAO Annual Meeting, including the first-ever full eye transplant, updates on Alcon’s Unity vitrectomy system, the LumiThera photobiomodulation platform, and the coming wave of AREDS 3 vitamins.

The episode then turns to a one-on-one interview with Cedric Francois, founder and CEO of Apellis Pharmaceuticals, whose journey from surgeon to biotech innovator led to the creation of Syfovre, the first approved treatment for geographic atrophy. Francois shares how a chance encounter at the Macula Society set his career in motion, the origins of complement inhibition research, and what it means to lead a mission-driven biotech as both a scientist and physician.

• AAO 2024 highlights:
• The world’s first whole-eye transplant — and what it could mean for future nerve regeneration research.
• Alcon’s new Unity vitreoretinal platform — first major system since Constellation.
• The promise and controversy of photobiomodulation in dry AMD care.
• Previewing AREDS 3 — a reformulated vitamin blend with added B vitamins and lower zinc.
• Inside the Apellis Story:
• How a Belgian surgeon became a biotech CEO in Kentucky.
• The early experiments that led to complement inhibition research.
• The role of serendipity at the Macula Society—and how a single conversation led to Apellis’s first investment.
• Lessons learned from Potentia’s first molecule (POT-4/APL-1) to Syfovre (pegcetacoplan)
• The transition from Louisville to Boston’s biotech hub.
• Why physician-founders bring unique empathy—and accountability—to innovation.

From the first eye transplant to the first therapy for geographic atrophy, Episode 1 sets the tone for RetinUp— candid, curious, and clinically relevant. Drs. Krzywonos and Kitchens explore how preparation meets luck, and how visionaries like Cedric Francois turn bold ideas into breakthroughs for patients.

Hosts: Scott Krzywonos and John Kitchens, MD

Guest: Cedric Francois, MD, PhD (Apellis Pharmaceuticals)

Business Operations: Liz Hogan

Production & Marketing: Laura Brown

🎧 Listen to RetinUp wherever you get your podcasts, or visit RetinUp.com to subscribe to our newsletter.

Hosts: John Kitchens, MD & Scott Krzywonos

Duration: 2:15

Welcome to RetinUp—the podcast where retina science meets real-world insight. Hosted by Dr. John Kitchens and Scott Krzywonos, RetinUp brings together leading voices in ophthalmology to explore new data, breakthrough research, and the stories behind the science shaping the future of retina care.

In this short trailer, John and Scott introduce the RetinUp mission, what listeners can expect from upcoming episodes, and how the show will connect researchers, clinicians, and innovators across the retina community.

Stay connected with RetinUp for upcoming interviews, conference recaps, and clinical discussions.

📱 Subscribe on Apple Podcasts, Spotify, or wherever you listen.\

🌐 Learn more at retinup.com

💬 Follow the conversation on LinkedIn with #RetinUpPodcast

John Kitchens, MD is a vitreoretinal surgeon with decades of clinical and research experience.

Scott Krzywonos is an editor, educator, and longtime retina media producer. Together, they bring clarity, humor, and insight to every conversation.