Ocular Therapeutix’s AXPAXLI Achieves 17.5% Vision Maintenance Advantage Over Aflibercept
AXPAXLI met the Week 36 superiority primary endpoint, with 74.1% of subjects maintaining vision versus 65.9% for aflibercept, a 17.5% risk difference (p=0.0006). Rescue-free rates in the AXPAXLI arm were 80.6% at Week 24 and 68.8% at Week 52, and an NDA filing is planned.
1. SOL-1 Phase 3 Trial Results
The SOL-1 trial randomized 344 wet AMD patients to a single 0.45 mg dose of AXPAXLI versus 2 mg aflibercept after an 8-week loading phase. At Week 36, 74.1% of AXPAXLI subjects maintained visual acuity versus 65.9% for aflibercept, yielding a 17.5% risk difference (p=0.0006), with AXPAXLI also showing a 21.1% advantage at Week 52 (p<0.0001). Rescue-free rates were 80.6%, 74.7% and 68.8% through Weeks 24, 36 and 52 respectively.
2. Safety and Tolerability
AXPAXLI was generally well-tolerated with no treatment-related ocular serious adverse events observed through the Week 52 database lock, including no cases of endophthalmitis, retinal vasculitis or implant migration.
3. Regulatory and Next Steps
Ocular plans to initiate formal discussions with the U.S. FDA to submit a New Drug Application based on SOL-1 data, with detailed results to be presented at the 49th Macula Society Annual Meeting. Subjects will be re-dosed at Week 52 and followed through Week 104 for long-term safety and durability assessments.