other material
confidence high
sentiment positive
materiality 0.65
EyePoint doses first patients in Phase 3 DME trials for DURAVYU; topline data 2H 2027
EyePoint, Inc.
- First patients dosed in global Phase 3 COMO and CAPRI trials of DURAVYU (vorolanib intravitreal insert) for diabetic macular edema.
- DURAVYU is a sustained-release TKI inhibiting VEGF, PDGF, and IL-6; design based on positive Phase 2 VERONA results.
- Non-inferiority trials vs aflibercept; ~240 patients each; primary endpoint BCVA change at weeks 52 and 56.
- DURAVYU 2.7mg administered via standard intravitreal injection every six months; topline data anticipated 2H 2027.
- Program aligns with FDA and EMA after End of Phase 2 meeting; aims to reduce treatment burden for DME patients.