EyePoint, Inc. 8K

EyePoint, Inc. reported mixed but generally supportive Phase 3 LUGANO topline data for DURAVYU in wet AMD—missing the primary endpoint in the full dataset yet showing non-inferiority in an ad hoc analysis and strong secondary outcomes—and reaffirmed plans for a 2027 NDA submission pending additional trial results.

On August 17, 2026, EyePoint, Inc. announced topline results from LUGANO, the first of two pivotal Phase 3 trials of its investigational sustained-delivery retinal therapy DURAVYU (vorolanib intravitreal insert) for wet age-related macular degeneration, reporting that while the study did not achieve its primary visual acuity non-inferiority endpoint versus on-label aflibercept in the full dataset due to an asymmetric 4% patient cohort with vision loss unrelated to wet AMD, an ad hoc analysis excluding that cohort showed non-inferiority and key secondary endpoints demonstrated reduced treatment burden, high rates of supplement-free durability, strong anatomic control, and a favorable safety profile, with the company reiterating plans to present further data, await topline results from the parallel Phase 3 LUCIA trial in Q4 2026, and potentially file an NDA in the first half of 2027.

Filing Facts

CIK

1314102

Ticker

EYPT

Form

8K

Source Type

fda

Accession

0001193125-26-353308

Alert Tier

7