Regeneron Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration (FDA) has extended the review period for two regulatory submissions related to EYLEA HD® (aflibercept) Injection 8 mg. The target action dates have been moved to the fourth quarter of 2025. This extension includes a Chemistry, Manufacturing and Controls $(CMC)$ Prior-Approval Supplement for the EYLEA HD prefilled syringe and a supplemental Biologics License Application (sBLA) aimed at expanding the treatment to include macular edema following retinal vein occlusion (RVO) and broadening the dosing schedule to allow for monthly dosing across approved indications. The delay was anticipated due to observations during an FDA inspection at Catalent Indiana LLC, the third-party manufacturer acquired by Novo Nordisk A/S. The FDA is expected to act swiftly once manufacturing issues are resolved. EYLEA HD remains available in the U.S. through vial administration with approved dosing intervals for various conditions.