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

Core Viewpoint - Regeneron Pharmaceuticals has announced that the FDA has accepted the supplemental Biologics License Application for EYLEA HD, which could become the first treatment for retinal vein occlusion (RVO) allowing for dosing every 8 weeks after an initial monthly period, potentially reducing the number of injections required compared to existing therapies [1][2]. Group 1: EYLEA HD Overview - EYLEA HD is being developed for the treatment of macular edema following RVO and aims to provide greater dosing flexibility with options for monthly dosing across approved indications [1][2]. - The FDA's target action date for EYLEA HD is August 19, 2025, following the use of a Priority Review voucher [1]. Group 2: Clinical Trial Data - The QUASAR trial, a Phase 3 study, demonstrated that EYLEA HD administered every 8 weeks after initial monthly doses achieved non-inferior visual acuity gains compared to EYLEA dosed every 4 weeks [2][6]. - The safety profile of EYLEA HD was consistent with EYLEA, with increased ocular pressure being the only notable adverse event occurring in 5% of patients [3][4]. Group 3: Market Context - RVO is a significant cause of vision loss affecting over 28 million people globally, highlighting the need for effective treatment options [10]. - Anti-VEGF therapies, including EYLEA, are commonly used to treat macular edema due to RVO, with EYLEA HD aiming to improve treatment adherence through reduced injection frequency [8][11]. Group 4: Company Background - Regeneron has a strong history in developing treatments for serious eye diseases, with EYLEA having transformed the treatment landscape for various chorioretinal vascular diseases [11][12]. - The company collaborates with Bayer AG for the development and marketing of EYLEA HD outside the U.S., sharing profits from sales [13].