Objective:
To present phase 3 SOL-1 trial data on vision maintenance, rescue treatment, and safety of OTX-TKI (Axpaxli) in neovascular AMD.
Approach:
- Study Design: A superiority study where treatment-naïve patients were randomized 1:1 to receive OTX-TKI or aflibercept after initial loading doses of aflibercept.
- Primary Endpoint: Maintenance of vision defined as less than a 15-letter loss over 36 weeks.
Key Findings:
- 74% of patients in the OTX-TKI arm maintained vision compared to 56% in the aflibercept arm at 36 weeks (P=0.0006).
- At 52 weeks, 66% of OTX-TKI patients maintained vision versus 44% of aflibercept patients.
- 30% of OTX-TKI patients required rescue treatment by week 52, compared to the same proportion in the aflibercept arm by week 28.
- Fluid stability was observed with a 30-nL difference in the OTX-TKI arm versus 60 nL in the aflibercept arm.
- OTX-TKI was safe and well tolerated, with common adverse events similar to those expected for intravitreal injections.
Interpretation:
Conclusion:
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