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In a companion piece to RetinUp’s previous episode on biosimilars, Stephen "Fred" Divers, MD, CMO of the American Oncology Network, shares a decade of hard-won lessons: ASP deterioration, formulary mandates, the race to the bottom — all in service of educating retina specialists about what they can do to anticipate forthcoming changes. Plus, John shares what it's like to operate in a new OR — and at altitude — after joining Rocky Mountain Retina Associates in Boulder.
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 RetinUp for one of his first interviews since the Lytenava FDA approval — covering launch timing, pricing philosophy, and what's next. Then Scott sits down with Miles Harper, an independent ophthalmology consultant and advisor, for a candid conversation about the connective tissue that drives innovation in eye care.
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: 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.
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