Ocular Therapeutix announced that it has enrolled more than 300 patients in its Phase 3 SOL-1 trial for Axpaxli (formerly OTX-TKI). Axpaxli is a bioresorbable hydrogel intravitreal implant that expresses axitinib, a small molecule tyrosine kinase inhibitor with antiangiogenic properties.

The SOL-1 trial (NCT06223958) will evaluate the safety and efficacy of Axpaxli as a treatment for neovascular (“wet”) age-related macular degeneration (nAMD). After an 8-week loading period, in which patients receive 2 doses of aflibercept 2 mg (Elyea; Regeneron), eligible subjects are randomized to receive either Axpaxli or aflibercept 2 mg and assessed monthly over 9 months. Subjects in any arm meeting prespecified rescue criteria will receive a supplemental aflibercept dose. The primary endpoint of SOL-1 is the proportion of subjects who maintain visual acuity, defined as a loss of <15 ETDRS letters of BCVA, at Week 36. Topline data from SOL-1 is expected in the fourth quarter of 2025.

In addition, the company also announced that Ocular’s second Phase 3 trial, SOL-R (NCT06495918), has begun enrolling patients. This study examines repeat dosing, with subjects receiving either Axpaxli at day 1 and re-dosed at week 24; aflibercept 8 mg Elyea HD; Regeneron) at day 1 and re-dosed at week 24; or aflibercept 2 mg on-label every 8 weeks. The company expects to enroll approximately 825 subjects. The primary endpoint of SOL-R is noninferiority in mean BCVA change from baseline between the Axpaxli and on-label aflibercept (2 mg) arms at 1 year.