other material
confidence high
sentiment positive
materiality 0.75
EyePoint doses first patient in Phase 3 LUGANO trial of DURAVYU for wet AMD; LUCIA trial by end 2024, topline 2026
EyePoint, Inc.
- First patient dosed in global Phase 3 LUGANO trial of DURAVYU (vorolanib) for wet AMD; non-inferiority design vs aflibercept.
- Second Phase 3 LUCIA trial first dosing expected by end of 2024; topline data anticipated in 2026.
- Trials enroll ~400 patients each; DURAVYU dosed every 6 months vs on-label aflibercept every 2 months, after 3 loading doses.
- Over 190 patients previously treated in DAVIO/DAVIO 2; favorable safety; treatment-naïve and treatment-experienced included.
- Re-dosing evaluated in both trials; primary endpoint: average change in BCVA at weeks 52 and 56 vs baseline.