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

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

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

Hosts: John Kitchens, MD, Scott Krzywonos

Topics Covered

Axpaxli / SOL-1 (Ocular Therapeutix)

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

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

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

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

Duravyu / LUGANO (EyePoint Pharmaceuticals)

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

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

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

Zenkuda / DAYBREAK (Kodiak Sciences)

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

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

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

Tabirafusp-ted also met its primary endpoint, but added no additional vision gains vs. aflibercept. IL-6 inhibition may have a stronger case in DME and uveitic macular edema; ALTO Phase 3 in DME is actively enrolling. Kodiak plans a Q4 2026 three-indication BLA for Zenkuda (wet AMD, diabetic retinopathy, RVO).

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

Remigromig / BRUNELLO (Merck)

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

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

John’s read: likely an add-on to anti-VEGF, not a replacement. Anti-VEGF co-therapy should mitigate the proliferative signal. Target population: the roughly 40% of DME patients with persistent edema despite treatment (per DRCR Protocol I and Protocol T). Monthly dosing is a practical disadvantage vs. Ozurdex; absence of cataract and IOP risk is the advantage. BAROLO companion study expected Q1–Q2 2027.

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

Laru-zova / VISTA (Beacon Therapeutics)

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

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

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

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

The Bigger Picture: Precision Retina?

The arrival of multiple new mechanisms in close succession raises a question Charles C. Wykoff, MD, PhD, floated on the Kodiak investor call: is retina approaching an oncology-style era where specific patients are matched to specific treatments?

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

Key Takeaways

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

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

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

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