Ocular Therapeutix Stock Skyrockets On Faster FDA Path For Vision Drug

Core Viewpoint - Ocular Therapeutix Inc. plans to accelerate the submission timeline for a New Drug Application (NDA) for Axpaxli in treating wet age-related macular degeneration (wet AMD), potentially submitting it after year one data from the ongoing SOL-1 Phase 3 clinical trial, expected in the first quarter of 2026 [1][4]. Regulatory Context - The FDA has historically required two well-controlled clinical trials for ophthalmic products, but recent statements suggest a shift towards accepting a single registrational trial if adequately powered and controlled [3]. - The expedited submission could lead to a potential approval decision over a year earlier than previously expected, making Axpaxli the first long-acting TKI to market [2]. Clinical Program and Data Readouts - The company anticipates that additional data from SOL-1, SOL-R, and SOL-X will demonstrate Axpaxli's efficacy, safety, and durability, facilitating its adoption in clinical practice [5]. - Ocular Therapeutix will continue to engage with the FDA regarding the regulatory pathway for Axpaxli and provide updates as necessary [5]. Market Reaction - Following the announcement, Ocular Therapeutix shares increased by 29.57%, reaching $16.30, marking a new 52-week high [7]. - HC Wainwright has maintained a Buy rating on Ocular Therapeutix and raised the price forecast from $19 to $21 [6].