Ocular Therapeutix™ Reports Positive Results from Landmark SOL-1 Phase 3 Superiority Trial in Wet AMD

mda2staff — Mon, 02 Mar 2026 18:28:42 +0000

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

“We are thrilled to report today’s historic data that position AXPAXLI to potentially become one of the most consequential advances in retina. SOL-1 data provide robust evidence that support AXPAXLI’s potential to deliver safe, durable, and clinically significant visual and anatomic outcomes with a meaningfully reduced treatment burden.”

Source: Ocular Therapeutix

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