Key Takeaways
- AXPAXLI beat aflibercept on vision maintenance at Weeks 36 and 52 in wet AMD.
- Durable effect with fewer rescues supports plans for FDA submission and further Phase 3 data.
Ocular Therapeutix reported positive topline results from the SOL-1 Phase 3 superiority trial of AXPAXLI (OTX-TKI) versus aflibercept 2 mg in newly diagnosed wet age-related macular degeneration. The pre-specified primary endpoint at Week 36 was met with high statistical significance (P = 0.0006), with 74.1% of AXPAXLI-treated patients maintaining vision (<15 ETDRS letters lost) versus 55.8% with aflibercept (risk difference 17.5%).
Durability was also significant at Week 52, with 65.9% of AXPAXLI patients maintaining vision compared with 44.2% on aflibercept (risk difference 21.1%;P < 0.0001). Rescue-free rates favored AXPAXLI at Weeks 24, 36, and 52 (80.6%, 74.7%, and 68.8%, respectively) versus aflibercept (72.1%, 56.4%, and 47.7%). On fluid control, 55.9% of patients on AXPAXLI maintained central subfield thickness within 30 μm at Week 36 versus 37.8% with aflibercept (nominal P = 0.0013).
AXPAXLI was generally well tolerated through Week 52, with no treatment-related ocular or systemic serious adverse events reported.
Detailed data will be presented at the Macula Society meeting (Feb. 25–28, 2026). The company plans to pursue FDA discussions and submit an NDA based on SOL-1, while the complementary SOL-R Phase 3 trial continues, with topline data expected in 1Q 2027.
Read the full press release here.
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