Thursday, Ocular Therapeutix, Inc. (OCUL) announced positive findings from the Phase 1 HELIOS study, which assessed Axpaxli against a sham control among patients with moderately severe to severe non-proliferative diabetic retinopathy or NPDR but without diabetic macular edema.
The company reported that Axpaxli was generally well-tolerated, with no observed inflammation.
In the Axpaxli group, 6 out of 13 patients experienced a 1 or 2-step enhancement in the Diabetic Retinopathy Severity Scale after 40 weeks. Additionally, none of the patients in the Axpaxli group showed a deterioration, unlike the 12.5% noted in the control group at the same time point.
The company highlighted that a single Axpaxli injection resulted in sustained DRSS improvement for up to 40 weeks.
Based on the encouraging HELIOS results, the company intends to proceed directly to a Phase 3 study involving Axpaxli for NPDR patients, pending FDA discussions.
Ocular stated that it plans to share the study outcomes at an upcoming meeting.
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