Ocular Therapeutix announced that it has completed enrollment in the SOL-R trial, a global phase 3 study evaluating Axpaxli, its investigational intravitreal treatment for neovascular age-related macular degeneration (nAMD). The trial has enrolled subjects across approximately 100 sites in the United States, Argentina, India, and Australia.

SOL-R is the second of 2 FDA-aligned registrational studies for Axpaxli, which delivers axitinib through a bioresorbable hydrogel implant. The study is designed to evaluate the safety and efficacy of Axpaxli administered every 6 months compared with aflibercept 2 mg (Eylea; Regeneron) dosed every 8 weeks. The primary endpoint is to demonstrate noninferiority in mean change in best corrected visual acuity at Week 56.

Ocular has set a target randomization of 555 subjects and reports it has now screened and enrolled enough participants to meet that goal. A previous amendment to reduce the SOL-R sample size was based on strong retention in the parallel SOL-1 trial and input from the FDA.

The company says top-line data from SOL-R is expected after the 56-week primary endpoint is reached. Pending positive results from both SOL-1 and SOL-R, Ocular plans to submit a New Drug Application seeking approval for Axpaxli in wet AMD. RP