Ocular Therapeutix’s AXPAXLI Outlasts Aflibercept by 23 and 22 Weeks in SOL-1 Trial
AXPAXLI extended median time to ≥30µM and ≥75µM CSFT increases to 39 and 46 weeks versus 16 and 24 weeks for aflibercept in SOL-1. AXPAXLI maintained Week 8 visual gains to Week 52, with lowest-vision subjects gaining +11.8 letters, and the company plans an NDA filing based on SOL-1 alone.
1. Phase 3 SOL-1 Trial Durability Results
Post-hoc analyses from SOL-1 demonstrated unmatched anatomic control with AXPAXLI. The median time to a ≥30µM CSFT increase from Week 8 was 39 weeks versus 16 weeks for aflibercept, and to a ≥75µM increase was 46 weeks versus 24 weeks. Hazard ratios of 0.7 and 0.5 indicated 30% and 50% lower risk of worsening events, respectively.
2. Sustained Visual Acuity Outcomes
AXPAXLI patients preserved loading phase gains through Week 52 across BCVA quartiles. Those in the lowest vision quartile improved by +11.8 ETDRS letters compared to +8.5 with aflibercept, while subjects starting near 20/20 vision showed minimal change.
3. NDA Filing and Safety Profile
Ocular Therapeutix remains on track to submit an NDA based solely on SOL-1 data, pending formal FDA discussions on single-trial approvals. Safety analyses showed vitreous floater AEs resolved by a mean of 20 weeks with no visible drug particles thereafter.