other material
confidence high
sentiment positive
materiality 0.80
EyePoint completes enrollment in both Phase 3 wet AMD trials for DURAVYU; topline data mid-2026
EyePoint, Inc.
- LUCIA enrolled over 400 patients in 7 months; combined LUGANO and LUCIA total over 800 patients.
- DSMC interim review confirmed safety consistent with prior trials; no protocol changes, continuation recommended.
- Topline 56-week data for LUGANO expected mid-2026; LUCIA topline data to follow shortly after.
- DURAVYU is sustained-release TKI with 6-month redosing; evaluated vs on-label aflibercept in non-inferiority design.
- Phase 3 program aligned with FDA/EMA; NDA filing targeted after one-year efficacy and safety endpoint.