Ocular Therapeutix announced that Axpaxli (OTX‑TKI) achieved statistical superiority to a low‑dose regimen of Regeneron/Bayer’s Eylea in the Sol‑1 Phase‑3 superiority trial for wet age‑related macular degeneration (AMD). The trial met its primary endpoint at 36 weeks, with Axpaxli maintaining vision in a larger share of patients after a single dosing regimen compared with the active control, per the company’s press release and MedCity News coverage. Despite the positive headline, investors sold the stock sharply: market commentary noted that the active control performed better than anticipated, narrowing the commercial delta. Analysts told reporters that the trial’s design and the magnitude of benefit will be closely scrutinized by retina specialists and payers when assessing real‑world uptake. Company statements indicate Ocular plans to pursue regulatory filings based on the superiority result and an FDA Special Protocol Assessment framed the trial’s statistical plan. Axpaxli is a bioresorbable intravitreal hydrogel delivering axitinib, a multi‑target TKI repurposed for intraocular sustained delivery. If cleared, Axpaxli would compete in a market dominated by anti‑VEGF biologics and newer longer‑acting agents; the clinical differentiation hinges on durability, safety, and dosing convenience.
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