Ocular Therapeutix announces results from Phase 1 data for AXPAXLI

Ocular Therapeutix announced positive topline results from the Phase 1 HELIOS study evaluating AXPAXLI versus a sham control in patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema. Ocular plans to present the study results at an upcoming meeting. Summary of Topline Phase 1 HELIOS Results Safety: AXPAXLI was generally well tolerated with no inflammation observed including no incidence of iritis, vitritis or vasculitis. Efficacy Results: 6 of 13 patients in the AXPAXLI group experienced a 1 or 2-step improvement in the Diabetic Retinopathy Severity Scale at 40 weeks, with 2 of the 6 having a 2-step improvement. No patients in the control group showed 1- or 2-step improvement at the same time point. No patients in the AXPAXLI group experienced any worsening in DRSS. 1 of 8 in the control group experienced worsening in the DRSS at 40 weeks. Durability of Effect: A single injection of AXPAXLI provided durable DRSS improvement up to 40 weeks. Rescue medication: No patients in either arm received rescue medication. Next Steps: Positive HELIOS results support decision to move directly to a Phase 3 study with AXPAXLI in patients with NPDR, pending discussions with the FDA. Data Release: Ocular plans to present topline results from the HELIOS study at a future meeting