Patients will be randomised to receive one of two doses of OTT166 or a placebo daily for 24 weeks. Credit: wavebreakmedia/Shutterstock.com.

OcuTerra Therapeutics has completed the enrolment of patients in its Phase II Diabetic Retinopathy: Early Active Management (DR:EAM) clinical trial of OTT166 eye drops.

The double-masked, randomised, multicentre study is designed to assess the efficacy and safety of low and high doses of the RGD integrin inhibitor OTT166 in adults with moderately severe to severe non-proliferative diabetic retinopathy, or mild proliferative diabetic retinopathy with minimal loss of vision.

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A total of 225 patients were enrolled. They will be randomised to receive one of two daily doses of OTT166 or a placebo, administered topically, for 24 weeks.

The percentage of patients experiencing a two-step improvement, as measured by the Diabetic Retinopathy Severity Scale (DRSS), is the primary efficacy endpoint.

The proportion of subjects having treatment-emergent adverse events is also a primary efficacy endpoint of the study.

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Additional endpoints of the study include the amount of delayed time to intravitreal injection and/or laser treatment, and measuring the prevention of progression to vision-threatening complications.

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Topline results from the study are anticipated in the first quarter of next year.

OcuTerra Therapeutics president and CEO Kerrie Brady said: “With limited therapeutic options for the treatment of DR on the market, we recognise an immense need for a non-invasive, earlier intervention.

“I want to thank the OcuTerra team, the investigators across our 65 trial sites, and of course, the patients who have played an essential role in our work.”

Biological activity and tolerability of the therapeutic in DR patients were also demonstrated in early studies.

OTT166 is a potent and selective small molecule that maintains an optimum balance of physiochemical properties.