DURAVYU (EYP-1901) - (LUCIA)

May 6, 2026: EyePoint, Inc. (NASDAQ: EYPT) reported Q1 2026 results and provided development updates for DURAVYU (vorolanib intravitreal insert; EYP-1901 proprietary name conditionally accepted by FDA), an investigational sustained-delivery therapy for retinal diseases.

DURAVYU in wet age-related macular degeneration (wet AMD): Phase 3 LUGANO and LUCIA trials (identical non-inferiority studies vs on-label aflibercept; >900 patients; q6-month re-dosing) are on track, with topline data expected beginning mid-2026 (LUGANO first, LUCIA to follow shortly). All active treated patients reached Week 32 (second dose); >35% have received the third planned dose at Week 56. Interim masked Phase 3 safety data were described as consistent with prior DURAVYU trials, with no safety signals.

DURAVYU in diabetic macular edema (DME): Phase 3 COMO and CAPRI are underway (non-inferiority vs on-label aflibercept; ~480 patients planned). Over one-third enrolled; ex-US site activation initiated. Enrollment completion expected Q3 2026; topline data anticipated Q4 2027.

Other: ARVO 2026 presentations included new preclinical data on inhibition of IL-6/JAK1 signaling and Phase 2 (DAVIO 2 in wet AMD; VERONA in DME) positive efficacy/safety outcomes.

Financials: Cash/investments $223M as of March 31, 2026, expected to fund operations into Q4 2027. Net loss $84.8M for Q1 2026.