Dosing begins in phase 2 clinical trial of diabetic retinopathy eye drop treatment
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The first patient has been dosed in the phase 2 DR:EAM clinical trial assessing OTT166 for the treatment of diabetic retinopathy, according to a press release from OcuTerra Therapeutics.
The multicenter, randomized, double-masked trial will include 200 adult subjects with moderately severe to severe nonproliferative diabetic retinopathy or mild proliferative diabetic retinopathy with minimal vision loss. They will be treated with daily topical OTT166 or placebo for 24 weeks.
The trial will investigate safety and efficacy, including the percentage of participants who have a two-step or greater improvement in the Diabetic Retinopathy Severity Scale, as well as measure the prevention of progression to vision-threatening complications and amount of delayed time to intravitreal injection or laser treatment.
“The initiation of the DR:EAM clinical trial marks an important milestone in our efforts to develop potentially the first topical eye drop treatment for diabetic retinopathy,” Kerrie Brady, CEO and president of OcuTerra Therapeutics, said in the release. “OTT166 has demonstrated tolerability and promising evidence of biological activity in patients in a phase 1b clinical trial, and we believe that it has the potential to dramatically change the treatment paradigm by enabling earlier, noninvasive, active treatment for patients with diabetic retinopathy if approved.”
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