EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the ...

EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the ...

If approved, EYLEA HD would be the first and only treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period – halving the number of injections that are indicated for all other anti-VEGF therapies

FDA Accepts Aflibercept 8 mg for Priority Review to Treat Retinal Vein Occlusion

If approved, aflibercept 8 mg would mark the first RVO treatment indicated for up to every 8-week dosing, halving the injection frequency of other anti-VEGF options.

FDA to review Regeneron’s sBLA for aflibercept injection 8mg

The FDA has accepted Regeneron Pharmaceuticals’ sBLA for Eylea HD (aflibercept) injection 8mg for priority review.

FDA accepts Regeneron's sBLA for Eylea HD as priority review

The sBLA seeks approval for Eylea HD for both the treatment of macular edema following retinal vein occlusion, and for broadening the dosing schedule to include every 4-week dosing across approved indications.

Regeneron’s sBLA for Eylea HD accepted for priority review by FDA

The sBLA seeks approval for Eylea HD for both the treatment of macular edema following retinal vein occlusion and broadening the dosing schedule to include every-4-week dosing across approved indications.