08:11 AM EST, 11/24/2025 (MT Newswires) -- Ocular Therapeutix ( OCUL ) said Monday that it has initiated a phase 3 registrational program for the potential treatment of non-proliferative diabetic retinopathy with Axpaxli.

Ocular said that the first patient has been randomized in the phase 3 Helios-3 trial, which will include 930 subjects with moderately severe to severe non-proliferative diabetic retinopathy without center-involved diabetic macular edema.

The company said the study will be conducted over three arms with different dosing regimens, with subjects set to be assessed every 12 weeks.

The primary endpoint of the study is the ordinal Diabetic Retinopathy Severity Scale 2-step change status by the end of 52 weeks from baseline, it added.