Axpaxli Shows 21.1% Durability Edge Over Eylea at Week 52
Axpaxli’s SOL-1 Phase 3 trial showed 74.1% of patients maintained vision at Week 36 versus 65.9% on Eylea, yielding a 17.5% risk difference. At Week 52, Axpaxli preserved vision in 65.9% of subjects versus 44.2% with Eylea, a 21.1% durability advantage that fell short of heightened investor expectations.
1. SOL-1 Trial Efficacy Results
Axpaxli achieved its primary endpoint in the SOL-1 Phase 3 trial by maintaining vision in 74.1% of patients at Week 36 versus 65.9% on Eylea, a 17.5% risk difference. At Week 52, 65.9% of Axpaxli subjects preserved vision compared to 44.2% with Eylea, reflecting a 21.1% durability advantage.
2. Regulatory Pathway and Label Potential
Ocular Therapeutix plans to engage the FDA for a New Drug Application based on SOL-1 data. If approved, Axpaxli could become the first tyrosine kinase inhibitor commercialized for wet AMD with a superiority label, while the SOL-R non-inferiority trial continues toward topline results in early 2027.
3. Implications for Regeneron
The demonstrated durability edge challenges Regeneron’s Eylea by establishing potential superiority in key vision endpoints. Investors may reassess Eylea’s competitive positioning and market share in wet AMD if Axpaxli secures a label highlighting its long-term vision retention.