EyePoint, Inc. announced topline results on October 19, 2026, from LUCIA, a pivotal Phase 3 clinical trial evaluating DURAVYU (vorolanib intravitreal insert) for the treatment of wet age-related macular degeneration (wet AMD). The trial enrolled 475 patients and randomized them 1:1 to receive DURAVYU 2.7 mg every 24 weeks or on-label aflibercept 2 mg every eight weeks, with supplemental aflibercept as needed.
Despite demonstrating visual improvement, DURAVYU did not achieve the primary endpoint of statistical non-inferiority in mean change in best corrected visual acuity (BCVA) compared to the aflibercept control. However, the company reported that key secondary endpoints were met. These included a 38% reduction in treatment burden, with 52% of eyes remaining supplement-free and 71% receiving zero or one supplement up to Week 56. The trial also showed a favorable safety profile with redosing and strong anatomic control.
EyePoint noted that the results from LUCIA are consistent with the first Phase 3 trial, LUGANO, which enrolled 432 patients and also did not meet the primary endpoint despite visual improvement. In LUGANO, DURAVYU demonstrated a 42% reduction in treatment burden and strong anatomic control. Pooled analyses of the LUCIA and LUGANO datasets are underway to further assess next steps for DURAVYU in wet AMD.
The company remains focused on its Phase 3 diabetic macular edema (DME) program. EyePoint is advancing the ongoing pivotal COMO and CAPRI clinical trials, with topline data expected in the fourth quarter of 2027. Additionally, the Phase 2 VERONA trial in DME met its primary endpoint, showing extended time to first supplemental injection compared to aflibercept control.
EyePoint management will host a conference call today, October 19, 2026, at 8:00 a.m. EDT to discuss the LUCIA results.
