Enrollment complete in phase 2 trial of diabetic retinopathy eye drops
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Key takeaways:
- Enrollment is complete in the phase 2 DR:EAM clinical trial of OTT166 eye drops.
- The trial is investigating the safety and efficacy of the drops for the treatment of diabetic retinopathy.
OcuTerra Therapeutics completed enrollment in the phase 2 DR:EAM clinical trial, which is investigating OTT166 eye drops for the treatment of diabetic retinopathy, according to a press release.
The multicenter, randomized, double-masked trial is assessing the safety and efficacy of OTT166, a small molecule RGD integrin inhibitor. Two hundred twenty-five adult patients with moderately severe to severe nonproliferative diabetic retinopathy or mild proliferative diabetic retinopathy were randomly assigned to receive either one of two doses of OTT166 or vehicle.
Image: Adobe Stock
The primary efficacy study endpoints at 24 weeks are the proportion of patients with treatment-emergent adverse events and the proportion of patients with an improvement of two steps or more from baseline in the Diabetic Retinopathy Severity Scale.
“OTT166 has demonstrated robust biological activity and the potential to modulate multiple key drivers of DR,” Carl D. Regillo, MD, principal investigator for the DR:EAM trial, said in the release. “This is an essential milestone for the development of a treatment that could benefit millions of patients with DR.”
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