Retinal PhysicianAxpaxli Superior to Aflibercept in Wet AMD Trial

Axpaxli (OTX-TKI), a single-injection bioresorbable intravitreal TKI insert, outperformed aflibercept in the phase 3 SOL-1 trial, marking the first investigational agent to demonstrate superiority over an approved anti-VEGF in wet AMD in over 20 years. An FDA NDA submission via accelerated pathway is planned.

🔬 Clinical Considerations

• At week 52, 65.9% of Axpaxli patients maintained vision vs 44.2% on aflibercept, a 21.1% risk difference (P<.0001)
• Superior anatomic control: 55.9% maintained CST within 30 μm of baseline at week 36 vs 37.8% for aflibercept
• Rescue-free rates at week 52 were 68.8% for Axpaxli vs 47.7% for aflibercept, reflecting meaningful durability advantage
• No treatment-related serious ocular adverse events, including no endophthalmitis, retinal vasculitis, or implant migration

🎯 Practice Applications

• Counsel treatment-naïve nAMD patients that a single-injection TKI option may be approaching approval
• Monitor FDA NDA review timeline; accelerated 505(b)(2) pathway targets near-term submission
• Attend Macula Society annual meeting in San Diego for full SOL-1 dataset presentation
• Follow HELIOS phase 3 program; Axpaxli is advancing into nonproliferative diabetic retinopathy

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