regulatory
confidence high
sentiment positive
materiality 0.75
EyePoint DSMC gives positive recommendation for Phase 3 DURAVYU wet AMD trials; no protocol changes
EyePoint, Inc.
- DSMC completed second scheduled review of Phase 3 LUGANO and LUCIA trials; no modifications recommended.
- All patients reached Week 8; ~25% received second planned DURAVYU dose at Week 32.
- Masked safety data shows no safety signals, consistent with prior DURAVYU trials.
- Topline 56-week data for LUGANO on track for mid-2026; LUCIA data to follow closely.