Acucela announced that the company initiated a phase 2 clinical trial with the enrollment of the first patient to assess the benefits of emixustat hydrochloride (emixustat) for the treatment of proliferative diabetic retinopathy (PDR), according to a company news release.
Acucela has submitted a clinical study protocol to the FDA and has received Institutional Review Board approval to initiate a randomized, placebo-controlled, phase 2 clinical trial evaluating emixustat in patients with PDR. In this 3-month study, 20 patients will be dosed once daily with oral emixustat. Pre-specified study endpoints include changes in cytokine expression levels associated with PDR severity and changes in ocular neovascularization. With the enrollment of the first patient, the phase 2 clinical trial is under way.
“I am excited to explore the potential benefit of emixustat in this serious sight threatening retinal disease affecting millions throughout the world,” stated Ryo Kubota, MD, PhD, and Chairman, President and CEO of Acucela.