other material
confidence high
sentiment positive
materiality 0.75
EyePoint announces Phase 3 plans for DURAVYU in wet AMD; positive Phase 2 data
EyePoint, Inc.
- Phase 3 LUGANO and LUCIA trials to enroll ~400 patients each; 2.7mg DURAVYU vs aflibercept; one-year endpoint.
- Phase 2 DAVIO 2 data: favorable safety, BCVA nearly identical to aflibercept at 12 months post single injection.
- After single DURAVYU dose, ~50% of eyes were supplement-free at 12 months vs 22% for aflibercept control.
- Phase 2 VERONA trial in DME fully enrolled with 27 patients; no drug-related SAEs reported.
- First patient dosing in Phase 3 LUGANO expected 2H 2024; FDA alignment on non-inferiority design with redosing.