Ocular Therapeutix has announced that its investigational hydrogel implant, Axpaxli (axitinib intravitreal implant), met the primary endpoint in the Phase III SOL-1 trial for wet age-related macular degeneration (wAMD), demonstrating superiority over a single injection of aflibercept. The implant, which delivers the tyrosine kinase inhibitor (TKI) axitinib, achieved a 74.1% rate of vision maintenance at 36 weeks compared to 55.8% for the aflibercept control group. The study also met key secondary endpoints, with 65.9% of patients in the Axpaxli arm maintaining vision at 52 weeks versus 44.2% in the comparator arm.

The trial also evaluated the proportion of patients not requiring rescue injections. At 52 weeks, 68.8% of patients treated with Axpaxli had not required rescue therapy, compared to 47.7% of those treated with aflibercept. The data suggest the potential for a durable, single-treatment benefit that could significantly reduce the treatment burden for wAMD patients, who typically require injections every one to two months with current standard therapies. The company plans to discuss the results with regulatory authorities.

According to PharmCube's NextBiopharm® database, Ocular is developing Axpaxli in a total of four ophthalmic indications. Click here to request a free trial for NextBiopharm®.