Ocular Therapeutix Stock Surges 30% Ahead of AXPAXLI Wet AMD Phase 3 Data Release
Ocular Therapeutix stock surged 30% in premarket trading as the company prepared to release topline Phase 3 data for AXPAXLI in wet AMD. The SOL-1 trial results will be presented at the Macula Society meeting later in February. The company plans to file for FDA approval using one-year data if results are favorable.
Ocular Therapeutix shares jumped roughly 30% in premarket trading on Feb. 17, 2026, as the company prepared to release topline results from its pivotal SOL-1 Phase 3 superiority trial of AXPAXLI for wet age-related macular degeneration. The biotech scheduled a webcast for 8:00 a.m. ET to review the data.
AXPAXLI, also known as OTX-TKI, is an axitinib intravitreal hydrogel developed using the company's proprietary bioresorbable hydrogel platform. The SOL-1 trial is evaluating the therapy's efficacy and durability in patients with wet AMD. The complete dataset from the trial is expected to be presented at the 49th Macula Society Annual Meeting, scheduled for Feb. 25-28 in Coronado, California.
In a December regulatory filing, Ocular Therapeutix noted that U.S. regulators typically require two well-controlled studies for approval of ophthalmic drugs in large markets such as wet AMD. The company acknowledged the risk that the FDA could reject a submission based on data from a single trial. Nevertheless, it plans to file a new drug application using one-year efficacy and safety data from SOL-1 if the results are favorable, along with interim safety data from the SOL-R extension study.
The market reaction reflects investor anticipation of the trial readout, which could significantly influence perceptions of the company's lead retinal asset. AXPAXLI is also being investigated for other retinal diseases. The company has already begun enrollment in SOL-X, an open-label extension trial designed to follow participants from earlier phase 3 studies.
AXPAXLI enters a competitive landscape for wet AMD treatment. Regeneron's Eylea remains a mainstay anti-VEGF injection therapy, while Roche's Vabysmo also targets retinal disease pathways with an injected approach. The key differentiator for AXPAXLI is its potential to extend the interval between treatments, a significant factor in a market where treatment frequency is a major patient concern.