Ocular Therapeutix Gets FDA Agreement for OTX-TKI in Wet AMD Trial

Ocular Therapeutix has obtained written FDA approval for the comprehensive design of its pivotal phase 3 clinical trial, known as the SOL trial, which evaluates Axpaxli (axitinib intravitreal implant) for treating wet age-related macular degeneration (AMD) under a Special Protocol Assessment (SPA).

In September 2023, Ocular Therapeutix initiated the SOL trial, intending to enroll roughly 300 treatment-naïve wet AMD subjects in the study eye. The SOL trial is structured as a multicenter, parallel-group study, primarily conducted at U.S. sites.

Subjects will be randomly assigned to receive either one aflibercept injection or one AXPAXLI implant, followed by supplementary anti-VEGF treatment, in line with predefined criteria. With the SPA agreement in place, the company will commence patient enrollment in the SOL trial and anticipates dosing the first subject by year-end.

Axpaxli is an experimental bioresorbable hydrogel implant that includes axitinib, a small molecule multi-target tyrosine kinase inhibitor with anti-angiogenic characteristics. It is currently under assessment for the treatment of wet AMD and other retinal disorders. Additionally, it is known by its laboratory code, OTX-TKI.