Ocular Therapeutix, Inc. 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 (?NPDR?, NCT05695417) without diabetic macular edema (DME). 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 (46.2%) patients in the AXPAXLI group experienced a 1 or 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) 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 (12.5%) 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.