If approved, Eylea would be the first treatment for RVO with 8-week dosing. The FDA target action date is Aug. 19, 2025.

The complete response letter did not identify any issues with the safety or efficacy of Eylea HD, Regeneron officials said.

Regeneron (REGN) Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted for Priority Review the supplemental Biologics License Application, sBLA, for EYLEA HD ...