Biopharmaceutical company Ocular Therapeutix, Inc. (NASDAQ: OCUL) on Tuesday announced it has received a written agreement from the US Food and Drug Administration under a Special Protocol Assessment for its planned registrational clinical trial of AXPAXLI (OTX-TKI) in non-proliferative diabetic retinopathy (NPDR).

The agreement establishes regulatory alignment on trial design and primary endpoints.

The company said the trial aims to expand AXPAXLI's potential beyond wet age-related macular degeneration into diabetic eye disease, a condition impacting nearly 9 million people in the United States. Ocular Therapeutix believes the therapy's potential for annual dosing could significantly improve outcomes and reduce the incidence of vision-threatening complications.

Diabetic retinopathy affects half of all diabetic patients during their lifetime and 6.4 million Americans are currently living with NPDR, however, despite the availability of anti-VEGF therapies, fewer than 1% of NPDR patients are treated, largely due to the burden of frequent intraocular injections.

Early data from the Phase 1 HELIOS trial showed no disease progression or vision-threatening complications at 48 weeks in NPDR patients receiving a single AXPAXLI injection, compared with deterioration in the control group. Improvements were also seen in patients with non-centre involved diabetic macular oedema.