EyePoint, Inc. 8K

EyePoint Pharmaceuticals reported detailed Phase 3 LUGANO trial data for DURAVYU in wet AMD, highlighting missed primary non-inferiority in the full set but supportive safety, treatment burden, and ad hoc efficacy analyses as it prepares for a potential NDA filing in 1H 2027 contingent on the LUCIA trial.

EyePoint Pharmaceuticals, Inc. furnished an investor presentation as Exhibit 99.1 providing expanded topline results and analyses from its Phase 3 LUGANO clinical trial of DURAVYU (vorolanib in bioerodible Durasert) for wet age-related macular degeneration, showing that although the study did not achieve the pre-specified primary non-inferiority endpoint versus on-label aflibercept in the full dataset, DURAVYU demonstrated favorable safety with repeat dosing, strong anatomic control, and a statistically superior reduction in treatment burden, and that ad hoc and modeling analyses excluding a small asymmetric cohort with ≥15-letter vision loss from non–wet AMD causes support its plan to use LUGANO, together with upcoming LUCIA Phase 3 results, to seek a wet AMD NDA filing targeted for the first half of 2027 and to advance related DME Phase 3 programs.

Filing Facts

CIK

1314102

Ticker

-

Form

8K

Source Type

sec

Accession

0001193125-26-387197

Alert Tier

6