Investing.com -- Ocular Therapeutix Inc. (NASDAQ:OCUL) stock surged 29% Monday after the company announced plans to accelerate its New Drug Application (NDA) submission for AXPAXLI in wet age-related macular degeneration (AMD).
The biopharmaceutical company intends to submit its NDA shortly after receiving year one data from its Phase 3 SOL-1 clinical trial, assuming positive results, which are expected in the first quarter of 2026. This accelerated timeline comes after recent statements from FDA leadership suggesting a potential shift toward requiring only a single registrational trial for approval.
Ocular plans to leverage the 505(b)(2) regulatory pathway, which could potentially shorten the review timeline for AXPAXLI. The company highlighted that its SOL-1 trial is the only ongoing Phase 3 retina trial being conducted under a Special Protocol Assessment agreement with the FDA.
"At Ocular Therapeutix, we have always been courageous, opportunistic, and bold in our efforts to redefine retina," said Pravin U. Dugel, Executive Chairman, President and CEO of Ocular Therapeutix. "Based on recent developments, we now intend to submit our NDA for AXPAXLI in wet AMD shortly after SOL-1 year one data, assuming positive results."
If approved, AXPAXLI could become the first tyrosine kinase inhibitor (TKI) to be commercialized for wet AMD. The company is positioning the treatment as potentially superior to existing options, with dosing intervals that could extend to 6-12 months compared to the more frequent injections required by current therapies.
Wet AMD affects approximately 1.8 million people in the United States and 14.5 million globally. Despite advances in treatment, up to 40% of patients discontinue therapy within the first year due to the burden of frequent injections.
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