RetinUp Podcast

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