DURAVYU (EYP-1901) - (LUGANO)

August 5, 2026: EyePoint, Inc. (NASDAQ: EYPT) said DURAVYU (vorolanib intravitreal insert) remains on track in pivotal Phase 3 retinal disease programs. In wet AMD, the identical non-inferiority Phase 3 trials LUGANO and LUCIA, each comparing DURAVYU with on-label aflibercept and using every-six-month re-dosing, enrolled over 900 patients; topline data from LUGANO are expected in August 2026 and from LUCIA in Q4 2026. A May 2026 DSMC review recommended both trials continue without protocol changes, and interim masked Phase 3 safety was reported as consistent with prior DURAVYU studies, with no drug-related safety concerns.

In DME, the pivotal Phase 3 COMO and CAPRI non-inferiority trials versus on-label aflibercept completed enrollment, with more than 480 patients enrolled in five months; topline data are expected in Q4 2027.

The company also highlighted May 2026 ARVO preclinical data showing vorolanib inhibition of JAK1/IL-6 signaling, and July 2026 ASRS presentations on DURAVYU’s mechanism, Phase 2 DAVIO 2 wet AMD learnings, post-hoc analyses aligned with Phase 3 criteria, and the DME program from Phase 2 VERONA to Phase 3. LUGANO data are planned for presentation at the Retina Society Annual Meeting in September 2026. EyePoint reported $180 million in cash and investments as of June 30, 2026, with runway into Q4 2027.