Ocular Therapeutix receives FDA agreement under SPA for trial of OTX-TKI

Ocular Therapeutix announced it had received written agreement regarding the overall design from the U.S. Food and Drug Administration, FDA, under a Special Protocol Assessment, SPA, for the Company’s ongoing pivotal Phase 3 clinical trial for AXPAXLI, for the treatment of wet age-related macular degeneration, which the Company refers to as the SOL trial. The Company initiated the SOL trial in September 2023 and expects to enroll approximately 300 evaluable wet AMD subjects who are treatment naive in the study eye in the trial. The SOL trial is designed to be a multi-center, parallel-group trial run primarily at U.S. sites, with subjects randomized to one injection of aflibercept or one implant of AXPAXLI followed by supplemental anti-VEGF treatment based on pre-specified 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 year-end.