EyePoint, Inc. — Form 8-K

EyePoint's LUGANO Phase 3 trial of DURAVYU (vorolanib) in wet AMD enrolled 427 patients (211 DURAVYU vs. 216 aflibercept control). The primary endpoint of non-inferiority in best-corrected visual acuity (BCVA) change from baseline to Week 52/56 was NOT achieved in the full dataset. However, DURAVYU achieved non-inferiority when an asymmetric cohort of 9 patients with ≥15-letter vision loss from non-wet AMD causes (geographic atrophy, glaucoma, retinal detachment) was excluded (nominal p=0.0096). Key secondary wins: 54% supplement-free rates (54% vs. aflibercept control), 42% fewer injections, and superior anatomic control (CST: −76 microns DURAVYU vs. −73 aflibercept). Safety profile was favorable; no insert migration or severe inflammation. Company plans pre-NDA meeting in Q4 2026 and NDA filing in H1 2027 if the parallel LUCIA trial (475 patients) reads out positively in Q4 2026.