FDA Delays Eylea Injection Review for Regeneron Pharmaceuticals

Regeneron Pharmaceuticals announced that the FDA has extended the target action dates for two regulatory submissions related to Eylea HD injection to Q4 2025. The submissions are for a prior-approval supplement and a biologics license application for the product, which is used to treat eye diseases.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates for two regulatory submissions related to Eylea HD injection to the fourth quarter of 2025. The submissions include a Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the Eylea HD prefilled syringe and a supplemental Biologics License Application (sBLA) seeking approval for the treatment of macular edema following retinal vein occlusion (RVO) and the broadening of the dosing schedule to include every 4-week (monthly) dosing across approved indications [1].

The FDA extended the review periods after determining that information provided since the completion of a recent inspection of a third-party manufacturer constituted a major amendment to each submission. The delay was anticipated and resulted from observations during an FDA general site inspection at the filler for these regulatory applications, Catalent Indiana LLC, which was acquired by Novo Nordisk A/S in December 2024. Novo Nordisk submitted a comprehensive response in early August 2025 to address the observations noted by the FDA. It is our understanding that the FDA will be able to act expeditiously on these applications once the manufacturing issues have been resolved [1].

Eylea HD remains available in the U.S. through vial administration. It is approved with dosing intervals from every 8 to 16 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), and every 8 to 12 weeks for patients with diabetic retinopathy (DR), following 3 initial monthly doses. The product is supported by a robust body of research and is currently approved in the U.S. to treat patients with wAMD, DME, and DR [1].

Regeneron Pharmaceuticals is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. The company's expertise in angiogenesis and decades of research serve as a foundation for its ongoing ambition to innovate new solutions for patients. Regeneron's robust and diverse research and development program in ophthalmology includes efforts to potentially address additional serious eye diseases [1].

References:
[1] https://www.globenewswire.com/news-release/2025/08/20/3136582/0/en/EYLEA-HD-aflibercept-Injection-8-mg-Applications-for-Expanded-U-S-Label-and-Prefilled-Syringe-Receive-FDA-Review-Period-Extension.html