Ocular Therapeutix announces first patient randomized in HELIOS-3 program

Ocular Therapeutix (OCUL) announced that the first patient has been randomized in the HELIOS-3 Phase 3 registrational program for AXPAXLI for the treatment of non-proliferative diabetic retinopathy. The HELIOS program is comprised of two complementary superiority studies, HELIOS-2 and HELIOS-3, designed to evaluate whether early AXPAXLI treatment, as infrequent as every 12 months, can meaningfully alter the course of non-proliferative diabetic retinopathy. Ocular is targeting a broad diabetic retinopathy label with the HELIOS program by including patients with non-center-involved diabetic macular edema. The studies utilize a novel ordinal greater than or equal to2-step diabetic retinopathy severity score primary endpoint. HELIOS-2 is a superiority study comparing AXPAXLI dosed every 12 months to ranibizumab, while HELIOS-3 compares 6- and 12-month dosing regimens of AXPAXLI to sham. The primary endpoint for each study is assessed at Week 52. Ocular has aligned with the FDA on the novel ordinal DRSS endpoint in its SPA agreement for HELIOS-2.