Ocular Therapeutix Reports Strong Week 52 Data for AXPAXLI in Wet AMD Trial
Event summary
- Ocular Therapeutix presented additional Week 52 data from the SOL-1 Phase 3 trial of AXPAXLI for wet AMD at the VBS meeting on April 13, 2026.
- AXPAXLI demonstrated a median time of 39 weeks and 46 weeks to ≥30 and ≥75 uM increases in CSFT from Week 8, respectively.
- 81% of AXPAXLI subjects were rescue-free at Week 24, with 75% remaining rescue-free at Week 36.
- The company plans to submit an NDA for AXPAXLI based on SOL-1 data alone, subject to FDA discussions.
The big picture
Ocular Therapeutix's positive Week 52 data for AXPAXLI reinforces its potential to redefine the treatment landscape for wet AMD. The company's strategy to submit an NDA based on a single pivotal trial aligns with recent FDA commentary, potentially accelerating the approval process. The durability and sustained disease control demonstrated by AXPAXLI could position it as a strong competitor in the wet AMD market, addressing challenges with current therapies such as frequent injections and patient discontinuation.
What we're watching
- Regulatory Pathway
- Whether the FDA will accept the NDA submission based on a single pivotal trial, SOL-1, as indicated by recent FDA commentary.
- Market Adoption
- The pace at which AXPAXLI could be adopted if approved, given its demonstrated durability and sustained disease control.
- Competitive Positioning
- How AXPAXLI's profile will compare to existing treatments for wet AMD in terms of efficacy, durability, and safety.