DURAVYU (EYP-1901) - (LUGANO)

Aug. 17, 2026: EyePoint, Inc. (NASDAQ: EYPT) reported topline Phase 3 LUGANO results for DURAVYU (vorolanib intravitreal insert) in wet age-related macular degeneration. The trial’s primary endpoint—non-inferiority vs on-label 2 mg aflibercept on change in BCVA at Weeks 52/56—was not achieved in the full dataset. The company said results were confounded by an asymmetric cohort of 9/211 patients (4%) with ≥15-letter vision loss unrelated to wet AMD; in an ad hoc analysis excluding these patients, DURAVYU was non-inferior to aflibercept (nominal p=0.0096).

Key secondary endpoints were reported as achieved: 42% reduction in treatment burden vs aflibercept (nominal p<0.0001), equal to about two fewer injections through Week 56; 76% supplement-free through Week 32 and 54% through Week 56; 94% received 0 or 1 supplement through Week 32 and 79% through Week 56. In a pre-specified analysis of supplement-free patients, BCVA change was non-inferior to supplement-free aflibercept (nominal p=0.0035). Safety was described as favorable with repeat dosing, with no difference in cataracts, elevated intraocular pressure, or intraocular inflammation, and no observed insert migration, retinal vasculitis, or severe IOI.

Upcoming catalysts: additional LUGANO data at the Retina Society meeting Sept. 23-26, 2026; LUCIA Phase 3 wet AMD topline data in Q4 2026; potential NDA submission in 1H 2027; Phase 3 DME trials COMO and CAPRI topline data expected Q4 2027.