OcuTerra Reports Publication of OTT166 Safety and Biological Activity Data From Phase 1b Study in Diabetic Eye Disease

OcuTerra Therapeutics announced the publication of a paper titled “The Safety and Biological Activity of OTT166, a Novel Topical Selective Integrin Inhibitor for the Treatment of Diabetic Eye Disease: A Phase 1b Study” in Ophthalmic Surgery, Lasers and Imaging Retina (OSLI Retina). The data show that OTT166 eyedrops were well-tolerated and demonstrated biological activity, warranting further evaluation for the treatment of diabetic eye disease.

In this Phase 1b, first-in-human study, 44 diabetic retinopathy (DR) patients who had the sight-threatening complication of diabetic macular edema (DME) were administered either a 2.5% or 5% concentration of OTT166 as an eyedrop twice daily for 28 days. Subjects were then monitored for an additional 28 days with no further treatment (observational phase), with 40 subjects completing the trial. As a Phase 1 study, no formal statistical hypothesis was tested. OTT166 was well-tolerated with no evidence of ocular or systemic toxicity, no drug-related serious adverse events reported, and generally stable BCVA throughout the study. There was a clinically meaningful reduction in mean and median central retinal thickness (CRT) in both groups combined at the end of the study (-22 / -28 microns, respectively) and 37% were deemed to be clinical responders as judged by three retina specialists reviewing the OCT scans of every patient.). Based on these findings, the Phase 2 DR:EAM (Diabetic Retinopathy: Early Active Management) study is underway to evaluate safety and efficacy of OTT166 in diabetic retinopathy.

“The data reported from the OcuTerra Phase 1 DR/DME study clearly showed the OTT166 eyedrop was well tolerated and demonstrated a robust biological activity signal worthy of continued evaluation,” said Jeffrey Heier, MD, director of the vitreoretinal service and director of retina research at Ophthalmic Consultants of Boston, and senior author and investigator for the study. “I am encouraged that we are developing a noninvasive treatment alternative that, if approved, I could potentially start my patients on earlier in their disease course and perhaps delay or even prevent the progression of retinopathy to the degree that repeated injections and/or laser would be indicated. As a member of the OcuTerra Scientific Advisory Board and a Phase 2 DR:EAM study investigator, I look forward participating in the next phases of development.”

“Current treatments available to those with serious diabetic eye disease leave significant unmet medical need, with most patients left to wait until their disease progresses to the late stage, at which time their only options are often invasive and burdensome,” said David Tanzer, MD, chief medical officer of OcuTerra Therapeutics. “The opportunity to deliver a noninvasive therapeutic to treat DR earlier has the potential to transform standard of care. We are pleased to share these positive results from the completed study, and we look forward to continuing work in the ongoing Phase 2 DR:EAM study of OTT166.”