Axpaxli Demonstrates Superiority Over Aflibercept in Phase 3 Wet AMD Trial
Axpaxli (OTX-TKI) met its primary endpoint in the SOL-1 Phase 3 trial, demonstrating superiority over aflibercept in preserving visual acuity in wet AMD patients at week 36. A single injection of the intravitreal hydrogel led to higher rescue-free rates and better fluid control, supporting potential for reduced treatment burden. Ocular Therapeutix plans to submit a New Drug Application to the FDA.
Axpaxli (Ocular Therapeutix, OTX-TKI), an intravitreal hydrogel combining a tyrosine kinase inhibitor and axitinib, met its primary endpoint in the phase 3 SOL-1 trial, demonstrating superiority over aflibercept in patients with wet age-related macular degeneration (AMD). The trial showed that a single injection of Axpaxli preserved visual acuity in a greater proportion of patients compared to a single dose of aflibercept.
The SOL-1 trial enrolled 344 recently diagnosed wet AMD patients who first received an 8-week loading phase of aflibercept injections before being randomized to either one Axpaxli 0.45 mg injection or one aflibercept 2 mg injection. At week 36, 74.1% of Axpaxli-treated patients lost fewer than 15 ETDRS letters of best-corrected visual acuity, compared to 55.8% of aflibercept-treated patients (risk difference 17.5%, p=0.0006). At one year, 65.95% of Axpaxli recipients maintained vision versus 44.2% of aflibercept recipients (risk difference 21.1%, p<0.00001). Rescue-free rates were higher for Axpaxli at every time point: 80.6% vs 72.1% at week 24, 74.7% vs 56.4% at week 36, and 68.8% vs 47.7% at week 52. Axpaxli also showed better central subfield thickness control within 30 µm at week 36 (55.9% vs 37.8%, nominal p=0.0013) and at one year (44.1% vs 34.9%, nominal p=0.1094).
Dr. Arshad Khanani, steering committee chair for the SOL Program, stated, “Axpaxli is the first and only drug with a novel mechanism to successfully demonstrate superiority to an approved anti-VEGF treatment in an FDA-aligned study for wet AMD.” He added that the data suggest “Axpaxli’s potential to significantly reduce treatment burden and optimize long-term visual outcomes.”
The company plans to submit a new drug application to the FDA for Axpaxli, subject to regulatory feedback. If approved, Axpaxli would be the first therapy of its kind available for wet AMD. The study’s findings may have limited generalizability to all clinical patients.