Trail run, Ocular Therapeutix stock tumbles after wet AMD trial results

Ocular Therapeutix (NASDAQ: OCUL) stock fell 35% Tuesday despite the company reporting positive results from its Phase 3 superiority trial for AXPAXLI in wet age-related macular degeneration (wet AMD).

The biopharmaceutical company announced that AXPAXLI met its primary endpoint in the SOL-1 trial, demonstrating superiority over aflibercept in maintaining vision at Week 36. According to the company, 74.1% of subjects in the AXPAXLI arm-maintained vision at this timepoint, representing a 17.5% risk difference compared to the aflibercept arm (p=0.0006).

The trial also showed that 65.9% of AXPAXLI-treated subjects-maintained vision at Week 52, with 68.8% of patients remaining rescue-free at that timepoint. The company highlighted that AXPAXLI was generally well-tolerated with no treatment-related ocular serious adverse events reported.

Ocular plans to submit a New Drug Application (NDA) based on the SOL-1 data, subject to planned discussions with the FDA. If approved, AXPAXLI could become the first tyrosine kinase inhibitor commercialized for wet AMD treatment.

Despite these seemingly positive results, investors appeared concerned about aspects of the data or potential regulatory hurdles, driving the significant stock decline. The company is continuing its complementary SOL-R Phase 3 non-inferiority trial, with topline data expected in the first quarter of 2027.