Ocular Therapeutix(US:OCUL) Globenewswire·2026-02-17 12:00Core Insights - AXPAXLI has demonstrated superiority over aflibercept in a Phase 3 trial for wet AMD, achieving significant visual acuity maintenance at both Week 36 and Week 52 [1][2][3] Group 1: Trial Results - The primary endpoint was met with 74.1% of subjects in the AXPAXLI arm maintaining vision at Week 36, showing a 17.5% risk difference (p=0.0006) compared to aflibercept [1][7] - At Week 52, 65.9% of subjects treated with AXPAXLI maintained vision, with a 21.1% risk difference (p<0.0001) compared to aflibercept [1][9] - Rescue-free rates for AXPAXLI were 80.6%, 74.7%, and 68.8% at Weeks 24, 36, and 52, respectively, compared to 72.1%, 56.4%, and 47.7% for aflibercept [1][11] Group 2: Safety Profile - AXPAXLI was generally well-tolerated with no treatment-related ocular serious adverse events (SAEs) reported [5][19] - The safety profile included a lower incidence of ocular adverse events compared to aflibercept, with only one SAE in the AXPAXLI arm [5][38] Group 3: Future Plans - The company plans to submit a New Drug Application (NDA) based on the SOL-1 data, pending discussions with the U.S. FDA [2][19] - Detailed results will be presented at the 49th Macula Society Annual Meeting scheduled for February 25-28, 2026 [16][20] Group 4: Mechanism and Technology - AXPAXLI is a bioresorbable intravitreal hydrogel incorporating axitinib, a multi-target tyrosine kinase inhibitor with anti-angiogenic properties [21][30] - The trial was conducted under a Special Protocol Assessment (SPA) agreement with the FDA, aiming for a superiority label for AXPAXLI in wet AMD [4][25] Group 5: Market Context - Wet AMD is a leading cause of severe vision loss, affecting approximately 14.8 million individuals globally, with current therapies facing challenges such as treatment burden and patient discontinuation [29] - AXPAXLI's potential to reduce treatment burden and improve long-term visual outcomes could lead to significant clinical adoption if approved [3][4]