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

FDA accepts Regeneron's sBLA for Eylea HD in RVO with priority review; QUASAR data supports monthly dosing, target action date set for August 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 broadening ...

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

Eylea HD is a high-dose version of Eylea. REGN’s EYLEA HD Improves Vision in RVO Patients Regeneron’s phase III QUASAR study evaluated the efficacy and safety of Eylea HD in patients with RVO ...

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 ...

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

In the European Union and United Kingdom, aflibercept 8 mg (Eylea HD in the US) is currently approved for neovascular ...

Supporting this application is data from the Phase 3 QUASAR trial, showing that EYLEA HD is comparable in efficacy to standard EYLEA with a safety profile consistent with previous findings.

Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for EYLEA HD Injection 8 mg. The sBLA seeks ...