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EYLEA HD® (aflibercept) Injection 8 mg Presentations at Angiogenesis 2026 Underscore Strength of its Clinical Profile for the Treatment of Serious Retinal Diseases
Globenewswire· 2026-02-02 12:00
Core Insights - Regeneron Pharmaceuticals is set to present new clinical data for EYLEA HD at the Angiogenesis annual meeting on February 7, 2026, highlighting its efficacy and safety in treating serious retinal diseases [1][2] Group 1: EYLEA HD Overview - EYLEA HD (aflibercept) Injection 8 mg has been approved by the FDA for treating macular edema following retinal vein occlusion (RVO), providing the first every-two-month treatment option for patients who previously required monthly treatments [2][10] - The Phase 3 QUASAR trial demonstrated that EYLEA HD met its primary endpoint at 36 weeks, with final long-term results to be presented at the upcoming meeting [2][3] - EYLEA HD aims to offer comparable efficacy and safety to the original EYLEA but with fewer injections, thus improving patient convenience [7][8] Group 2: Clinical Trials and Data - The Phase 3b ELARA trial will present full primary data for EYLEA HD dosed every 4 weeks in patients with wet age-related macular degeneration (wAMD) or diabetic macular edema (DME) [3] - Data from the ELARA trial supports the approval of EYLEA HD as a monthly treatment option for patients who require more frequent dosing, showing that patients switching from other anti-VEGF agents generally improved their vision [2][3] Group 3: Safety and Adverse Reactions - Common adverse reactions (≥3%) reported in patients treated with EYLEA HD include cataract, conjunctival hemorrhage, and increased intraocular pressure [4][10] - The safety profile of EYLEA HD is consistent with that of EYLEA, with potential side effects including eye pain, retinal hemorrhage, and blurred vision [4][12] Group 4: Upcoming Presentations - Regeneron will present various studies at the Angiogenesis meeting, including the correlation of foveal invasion with visual function and the safety and efficacy of aflibercept 8 mg in patients with nAMD or DME [5]
Why Is Eye Disease Focused Kala Bio Stock Plunging On Monday?
Benzinga· 2025-09-29 16:00
Core Points - Kala Bio Inc. has halted the development of its experimental treatment KPI-012 for persistent corneal epithelial defect (PCED) after the CHASE Phase 2b trial did not meet its primary endpoint of complete healing [2][4] - The trial also failed to achieve statistical significance for key secondary efficacy endpoints, showing no meaningful difference between the treatment and placebo arms [3] - Following the trial results, the company plans to cease development of KPI-012 and its mesenchymal stem cell secretome (MSC-S) platform, while evaluating strategic options and engaging with its secured lender [4] Financial Summary - As of June 30, Kala Bio had cash and cash equivalents of $31.9 million, which is expected to fund operations into the first quarter of 2026 [5] - The company's stock price has dropped significantly, down 91.44% to $1.63 [5]
EYLEA HD® (aflibercept) Injection 8 mg Presentations at ARVO Reinforce Continued Safety and Efficacy and Highlight Early Real-World Outcomes for Patients with Serious Retinal Disease
Globenewswire· 2025-04-28 11:00
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]