Clinical TrialMay 14, 2026, 07:11 AM
EyePoint Receives 3rd Positive DSMC Recommendation for DURAVYU Phase 3
AI Summary
EyePoint, Inc. announced its third consecutive positive recommendation from the independent Data Safety Monitoring Committee (DSMC) for its pivotal Phase 3 program evaluating DURAVYU™ for wet age-related macular degeneration (wet AMD). The DSMC recommended that both the LUGANO and LUCIA trials continue as planned without modifications, reinforcing confidence ahead of topline data expected in mid-2026. The masked safety data from Phase 3 trials continue to show a favorable safety profile, consistent with previous studies involving over 190 patients. All active patients have received their second DURAVYU dose, with over 35% receiving a third dose.
Key Highlights
- DSMC issued its third consecutive positive recommendation for DURAVYU Phase 3 wet AMD trials.
- LUGANO and LUCIA trials to continue as planned with no protocol modifications.
- Topline data for LUGANO trial expected in mid-2026, LUCIA to follow shortly.
- Favorable safety profile observed in masked Phase 3 data, consistent with 4 prior trials (190+ patients).
- All active patients in treatment arm reached Week 32 (second dose); over 35% received third dose (Week 56).
- Over 900 patients enrolled across both LUGANO and LUCIA Phase 3 trials.
- DURAVYU Phase 3 trials for DME (COMO and CAPRI) are actively recruiting patients.
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