Ocular Therapeutix reported topline data from its SOL-1 Phase 3 superiority trial of Axpaxli (0.45 mg) versus aflibercept (2 mg) in wet AMD. At Week 36, 74.1% of Axpaxli patients maintained vision compared to 65.9% on aflibercept (17.5% risk difference, p=0.0006). By Week 52, vision maintenance was 65.9% versus 44.2% (21.1% risk difference), and 80.6% of Axpaxli subjects remained rescue-free at Week 24. Key secondary and exploratory endpoints achieved statistical significance or numerical superiority.

Shares of Ocular Therapeutix plunged 26.5% in premarket trading following the release, reflecting investor concern that Axpaxli’s durability edge did not meet lofty expectations. The stock trades near its 52-week low of $5.79 after a 23.3% gain over the past year, underscoring volatility despite long-term positive momentum.

The company plans formal FDA discussions to support a New Drug Application based on SOL-1 data, aiming to bring the first tyrosine kinase inhibitor to market with a superiority label in wet AMD. The SOL-R non-inferiority Phase 3 trial will continue, with topline data expected in Q1 2027, while Sanofi has expressed acquisition interest in Ocular Therapeutix.