Regeneron Pharmaceuticals, Inc. announced that the US FDA accepted for Priority Review the supplemental Biologics License Application (sBLA) for EYLEA HD® Injection 8 mg. The sBLA seeks approval for EYLEA HD for both the treatment of macular edema following RVO, and for broadening the dosing schedule to include monthly dosing across approved indications.
[EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing in Approved Indications]
