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

Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks ...

The sBLA seeks approval for Eylea HD for both the treatment of macular edema following retinal vein occlusion, and for ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept injection 8mg for the treatment of macular edema following ...

EYLEA HD is a treatment for retinal vein occlusion (RVO) that allows for dosing every 8 weeks after initial monthly doses, potentially halving injections. What is the FDA's action date for EYLEA ...

as measured by the Early Treatment Diabetic Retinopathy Study letter score. QUASAR is being operationalized by Bayer under a collaboration agreement with Regeneron. About Retinal Vein Occlusion ...

The FDA has sent Regeneron a complete response letter, rejecting its bid to stretch the administration of high-dose Eylea ...

The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application ...

Regeneron (REGN) announces FDA review of sBLA for Eylea HD to treat macular edema and expand dosing. Read more here.

Regeneron Pharmaceuticals has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its Eylea HD eye drug.