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Ocular Therapeutix Shares Topline Results From SOL-1 Phase 3 Superiority Trial Of Axpaxli For Wet Age-related Macular Degeneration, The Superiority Primary Endpoint At Week 36 Was Met

Benzinga·02/17/2026 12:08:49

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First ever successful demonstration of superiority in an FDA-aligned wet AMD trial comparing a novel investigative agent to an approved anti-VEGF treatment
Superiority primary endpoint met with 74.1% of subjects in the AXPAXLI™ arm maintaining vision at Week 36, a 17.5% risk difference (p=0.0006), compared to aflibercept (2 mg) arm
65.9% of subjects treated with AXPAXLI maintained vision at Week 52, a 21.1% risk difference (p<0.0001), compared to aflibercept (2 mg) arm
Rescue-free rates in the AXPAXLI arm were 80.6%, 74.7%, and 68.8% at Weeks 24, 36, and 52
55.9% of subjects treated with AXPAXLI maintained CSFT within 30 μm from baseline at Week 36, a 17.1% risk difference (nominal p=0.0013) compared to aflibercept (2 mg) subjects
77.1% of AXPAXLI subjects randomized in SOL-1 would have been rescue-free at Week 24 using SOL-R rescue criteria which align closely with clinical practice
AXPAXLI was generally well-tolerated in SOL-1 with no treatment-related ocular SAEs
Subjects have been re-dosed at Week 52
Ocular plans to submit New Drug Application (NDA) based on SOL-1 data, subject to planned formal discussions with U.S. FDA