DURAVYU ( EYP-1901 vorolanib intravitreal) - (COMO)

July 30, 2026: EyePoint, Inc. (NASDAQ: EYPT) announced it has completed enrollment in COMO and CAPRI, two global Phase 3 randomized, double-masked, on-label 2 mg aflibercept-controlled non-inferiority trials of DURAVYU (vorolanib intravitreal insert) for diabetic macular edema (DME). The trials enrolled over 480 patients across both studies, completing full enrollment ahead of schedule in five months. Topline 56-week (Weeks 52 and 56 blended) data for both DME trials are expected in 4Q 2027.

COMO/CAPRI design: patients (treatment-naïve and previously treated) are randomized Day 1 to DURAVYU 2.7 mg or aflibercept control; DURAVYU is re-dosed every six months. Primary endpoint is non-inferior change from baseline in best-corrected visual acuity vs aflibercept; secondary endpoints include safety, treatment-burden reduction, proportion free of supplemental aflibercept, and OCT-based anatomic outcomes.

Other catalysts: In May 2026, a DSMC reviewed masked safety data across ongoing Phase 3 wet AMD and DME programs and recommended continuation without protocol changes. EyePoint reiterated that Phase 3 wet AMD program data are anticipated beginning in August 2026.