Ocular Therapeutix Inc. (NASDAQ:OCUL) shares dropped 35% on Tuesday even after the company announced favorable results from its Phase 3 superiority study of AXPAXLI in patients with wet age-related macular degeneration (wet AMD).
The biotech group said AXPAXLI achieved the primary endpoint in the SOL-1 trial, showing superiority over aflibercept in preserving vision at Week 36. According to the company, 74.1% of patients treated with AXPAXLI maintained vision at that point, reflecting a 17.5% risk difference compared with the aflibercept group (p=0.0006).
At Week 52, 65.9% of participants receiving AXPAXLI maintained vision, while 68.8% remained free from rescue treatment. Management also noted that the therapy was generally well tolerated, with no treatment-related serious ocular adverse events reported.
Ocular said it intends to file a New Drug Application (NDA) based on the SOL-1 findings, pending discussions with the U.S. Food and Drug Administration. If approved, AXPAXLI would be the first tyrosine kinase inhibitor brought to market for wet AMD.
Despite the headline-positive outcome, investors appeared to focus on potential concerns within the dataset or possible regulatory uncertainties, triggering the sharp selloff.
The company is also advancing its complementary SOL-R Phase 3 non-inferiority study, with topline results anticipated in the first quarter of 2027.
Comprehensive data from the SOL-1 trial are scheduled to be presented at the 49th Macula Society Annual Meeting later this month.