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 [email protected].

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