Ocular Therapeutix Receives FDA Agreement Under Special Protocol Assessment for its First Pivotal Clinical Trial of OTX-TKI in Wet AMD

Ocular Therapeutix announced it has received written agreement regarding the overall design from the FDA under a Special Protocol Assessment (SPA) for the company’s ongoing pivotal phase 3 clinical trial for Axpaxli (axitinib intravitreal implant), for the treatment of wet age-related macular degeneration (AMD), which the company refers to as the SOL trial.

Ocular Therapeutix initiated the SOL trial in September 2023 and expects to enroll approximately 300 evaluable wet AMD subjects who are treatment naïve in the study eye in the trial. The SOL trial is designed to be a multicenter, parallel-group trial run primarily at US sites, with subjects randomized to one injection of aflibercept or one implant of AXPAXLI followed by supplemental anti-VEGF treatment based on prespecified criteria. With the agreement under the SPA, the company will begin enrolling patients in the SOL trial and expects to dose the first subject by the end of the year.

Axpaxli is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD and other retinal diseases. Axpaxli is also referred to by its laboratory code, OTX-TKI.