First and only FDA-approved treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period Monthly dosing option in all approved indications provides greater dosing flexibility for more personalized patient care TARRYTOWN, N.Y., Nov. 19, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA HD® (aflibercept) Injection 8 mg for the treatment of patients with macular edema f ...

Core Viewpoint - The U.S. FDA has extended the target action dates for Regeneron Pharmaceuticals' EYLEA HD regulatory submissions to the fourth quarter of 2025 due to major amendments resulting from a recent inspection of a third-party manufacturer [1][2] Group 1: Regulatory Updates - The FDA's extension of review periods was prompted by significant information provided after an inspection at Catalent Indiana LLC, which is now owned by Novo Nordisk A/S [2] - Novo Nordisk submitted a comprehensive response to the FDA in early August 2025 to address the observations noted during the inspection [2] - EYLEA HD remains available in the U.S. through vial administration, with approved dosing intervals ranging from every 8 to 16 weeks for various conditions [3] Group 2: Product Information - EYLEA HD is a vascular endothelial growth factor inhibitor developed to provide comparable efficacy and safety to EYLEA but with fewer injections [5] - EYLEA HD is approved in the U.S. for treating patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR) [8] - EYLEA HD is being jointly developed by Regeneron and Bayer AG, with Regeneron holding exclusive rights in the U.S. and Bayer having exclusive marketing rights outside the U.S. [6] Group 3: Company Overview - Regeneron is a leading biotechnology company focused on developing life-transforming medicines for serious diseases, leveraging its unique ability to translate science into medicine [11] - The company has a robust research and development program in ophthalmology, aiming to address additional serious eye diseases [7] - Regeneron utilizes proprietary technologies to accelerate drug development and is committed to innovative solutions for patients [12]

Core Insights - Regeneron Pharmaceuticals is set to present 27 abstracts, including eight oral presentations on EYLEA HD, at the ARVO 2025 Annual Meeting, showcasing its effectiveness in treating wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR) [1][2][5] Group 1: EYLEA HD Efficacy and Real-World Data - Initial real-world data from nearly 40,000 patients treated with EYLEA HD indicate positive impacts on vision and longer dosing intervals in everyday clinical practice [2][6] - New analyses will compare EYLEA HD and faricimab regarding efficacy, dosing frequency, and potential economic benefits for patients with wAMD and DME [1][6] Group 2: Presentations at ARVO - Key presentations will include analyses of real-world experiences with EYLEA HD among treatment-naive patients and those switching from other anti-VEGF therapies [6][8] - A network meta-analysis will indirectly compare the efficacy and number of injections for EYLEA HD and faricimab based on Phase 3 clinical trial data [6][8] Group 3: Safety and Adverse Reactions - The most common adverse reactions (≥3%) reported in patients treated with EYLEA HD include cataract, conjunctival hemorrhage, and increased intraocular pressure [3][29] Group 4: Economic Impact and Modeling - A modeling analysis will assess the potential economic benefits of EYLEA HD compared to faricimab for treating patients with wAMD or DME in the U.S. over three years [6][8] Group 5: Background on EYLEA HD - EYLEA HD is developed to provide comparable efficacy and safety to EYLEA but with fewer injections, and it is currently approved in the U.S. for treating wAMD, DME, and DR [19][20] - The drug is part of a broader research and development program at Regeneron aimed at addressing serious eye diseases [21]