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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]