EyePoint’s DURAVYU Phase 3 Trials Secure Third DSMC Review with 35% Third Dose
The Data Safety Monitoring Committee issued its third review recommending LUGANO and LUCIA Phase 3 wet AMD trials of DURAVYU continue without modification, with enrollment exceeding 900 and 35% of patients dosing a third time by Week 56. Topline LUGANO data are on track for mid-2026 after favorable safety findings.
1. DSMC Recommends Continuation of Trials
The independent Data Safety Monitoring Committee completed its third scheduled review and unanimously recommended the pivotal LUGANO and LUCIA Phase 3 wet AMD trials of DURAVYU continue without protocol modifications.
2. Enrollment and Dosing Progress
Enrollment is complete with over 900 patients randomized one-to-one to DURAVYU 2.7 mg every six months or aflibercept control; all active treatment-arm patients reached their second dose visit at Week 32 and 35% have received the third dose at Week 56.
3. Interim Safety Profile
Masked safety data from the Phase 3 program show a continued favorable safety profile for DURAVYU, consistent with findings in over 190 patients across four completed clinical trials and with no new safety concerns.
4. Upcoming Topline Data Wave
Topline LUGANO data are on track for mid-2026, with the LUCIA readout to follow shortly thereafter, positioning DURAVYU for potential first- and best-in-class status in wet AMD treatment.