Axpaxli’s 21.1% Durability Lead Over Aflibercept Falls Short of Hopes
Ocular Therapeutix’s SOL-1 Phase 3 trial showed its Axpaxli treatment maintained vision in 65.9% of patients at Week 52 versus 44.2% with aflibercept, a 21.1% durability gap. The narrower-than-expected advantage tempered investor expectations and could limit competitive pressure on Regeneron’s Eylea.
1. SOL-1 Phase 3 Trial Outcomes
Ocular Therapeutix’s SOL-1 trial compared a single 0.45 mg dose of Axpaxli to a 2 mg dose of aflibercept, showing 74.1% vision maintenance at Week 36 versus 65.9% for aflibercept (17.5% risk difference, p=0.0006). At Week 52, 65.9% of Axpaxli patients maintained vision versus 44.2% in the aflibercept arm, a 21.1% advantage, and 80.6% of Axpaxli subjects were rescue-free at Week 24.
2. Regulatory Submission Plans
Ocular Therapeutix plans to submit a New Drug Application based on SOL-1 data, with formal discussions scheduled with the FDA. If approved, Axpaxli would become the first tyrosine kinase inhibitor for wet AMD with a superiority label and leading durability.
3. Competitive Implications for Eylea
The smaller-than-anticipated durability edge may ease investor concerns over Eylea’s market position, though any label superiority could still pressure Regeneron on pricing and share. Regeneron may adjust its commercial strategy to reinforce Eylea’s established efficacy and durability profile.