Core Insights - The FDA has approved EYLEA HD (aflibercept) Injection 8 mg for treating macular edema following retinal vein occlusion (RVO), allowing for dosing every 8 weeks after an initial monthly dosing period [1][2] - EYLEA HD offers a monthly dosing option across all approved indications, enhancing treatment flexibility for healthcare providers [1][2] Approval Details - EYLEA HD is the first FDA-approved treatment for RVO that can potentially reduce the number of injections by half compared to existing therapies [2] - The approval is based on the Phase 3 QUASAR trial, which demonstrated non-inferior visual acuity gains for EYLEA HD patients dosed every 8 weeks compared to EYLEA dosed every 4 weeks [2][6] Dosing Information - EYLEA HD is approved for various dosing intervals: every 8 to 16 weeks for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), every 8 to 12 weeks for diabetic retinopathy (DR), and every 8 weeks for RVO [4] - Some patients may not maintain a response with extended dosing intervals and may benefit from resuming every 4-week dosing [4] Patient Support Initiatives - Regeneron is committed to helping patients access EYLEA HD through the EYLEA 4U program, which assists with insurance coverage and financial aid [5] Clinical Trial Overview - The QUASAR trial was a global, double-masked, active-controlled Phase 3 study evaluating EYLEA HD's efficacy and safety in patients with RVO [6][7] - Patients were randomized into three groups to receive different dosing regimens, with the primary endpoint being the mean change in best-corrected visual acuity (BCVA) [7] Background on RVO - RVO is a significant cause of vision loss in adults, affecting over 28 million people globally [10] - It occurs due to a blockage in a retinal vein, leading to complications such as macular edema [8][9] About EYLEA HD - EYLEA HD was developed to provide comparable efficacy and safety to EYLEA but with fewer injections, addressing the needs of patients with serious chorioretinal vascular diseases [12][11] - It is jointly developed by Regeneron and Bayer AG, with Regeneron maintaining exclusive rights in the U.S. [13]

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]