EyePoint targets mid-2026 wet AMD readout as losses widen
EyePoint Pharmaceuticals has reported a net loss of $84.8 million for the first quarter of 2026, as the Watertown, Massachusetts company accelerates two large Phase 3 programmes for its sustained-delivery retinal candidate DURAVYU (vorolanib intravitreal insert) and scales up its commercial manufacturing facility.
The company's two identical Phase 3 trials in wet age-related macular degeneration — LUGANO and LUCIA — are on track, with all active patients in the treatment arm having reached the Week 32 visit and more than 35% having received their third planned dose at Week 56. Topline data from LUGANO is expected to begin emerging from mid-2026, with LUCIA results to follow shortly afterwards. Both studies are non-inferiority trials against on-label aflibercept and have enrolled more than 900 patients combined.
Jay Duker, President and Chief Executive, said DURAVYU's "multi-mechanism of action" and six-monthly re-dosing interval position it for "best- and first-in-class potential" in the two largest retinal disease markets. The company is positioning DURAVYU as a synergistic agent, combining VEGFR and PDGF inhibition with a JAK1-mediated anti-inflammatory effect — the latter supported by new preclinical data presented at the Association for Research in Vision and Ophthalmology Annual Meeting in May 2026.
Pipeline progress
EyePoint's Phase 3 diabetic macular oedema programme, comprising the COMO and CAPRI trials, is advancing in parallel. More than one-third of the anticipated 480-patient enrolment has been completed, and international sites outside the United States have begun activation. Full enrolment is expected in the third quarter of 2026, with topline data anticipated in the fourth quarter of 2027.
Phase 2 readouts in both wet AMD (DAVIO 2) and DME (VERONA), also presented at ARVO 2026, showed durable single-dose efficacy with improved visual acuity and anatomical control, and no ocular or systemic serious adverse events attributable to DURAVYU. The company stated that interim masked safety data from the Phase 3 studies remain consistent with this earlier profile.
On the financials, operating expenses rose to $87.9 million from $73.3 million in Q1 2025, driven by Phase 3 trial costs and manufacturing scale-up. Revenue collapsed to $0.7 million from $24.5 million in the prior-year period, though the 2025 figure was substantially inflated by recognition of deferred revenue from EyePoint's 2023 YUTIQ licence agreement and is therefore not a meaningful like-for-like comparator. Cash, equivalents, and marketable securities stood at $223 million at the end of March, down from $306 million at year-end 2025; the company expects this to fund operations into the fourth quarter of 2027.
Market context
Wet AMD and DME represent the two highest-volume segments in retinal disease and together constitute a market valued by analysts in the tens of billions of dollars globally. The current standard of care is dominated by intravitreal anti-VEGF agents, principally aflibercept (Eylea) and ranibizumab biosimilars, administered every four to twelve weeks. The central commercial proposition for DURAVYU is its six-month re-dosing interval, which, if maintained in Phase 3, would meaningfully reduce the treatment burden for patients and practitioners alike.
EyePoint is not alone in pursuing sustained-delivery formats for retinal disease. Apellis Pharmaceuticals' port-delivery system for ranibizumab (Susvimo) has faced manufacturing setbacks, and a number of other companies are developing biodegradable or implantable platforms in the same indication. Whether the LUGANO topline data, expected within weeks, will be sufficient to differentiate DURAVYU commercially will depend heavily on the magnitude of non-inferiority versus aflibercept and on the durability of the six-month dosing window in the broader Phase 3 population.