Ocular Therapeutix announces FDA agreement to amend SPA for AXPAXLI

Ocular Therapeutix announced that the U.S. Food and Drug Administration, FDA, has agreed to a Special Protocol Assessment, SPA, Agreement Modification for the Company’s pivotal Phase 3 SOL clinical trial of AXPAXLI for the treatment of wet age-related macular degeneration. The SPA Agreement Modification enables the trial to include treatment-naive wet AMD subjects with visual acuity of approximately 20/80 or better at the initial screening visit. After two aflibercept injections in the screening period, eligible participants would need to gain at least 10 ETDRS letters from the initial screening visit to Day 1 or achieve a visual acuity of approximately 20/20 or better at Day 1, in addition to satisfying other criteria, to qualify for enrollment in the trial. The SPA Agreement Modification also allows the pivotal trial to move forward, evaluating AXPAXLI with a single optimized implant with a drug load of 450 microgram of a more soluble form of axitinib.