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Kubota Vision Inc. (“Kubota Vision”), a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), announced today that the company has completed subject enrollment in its ongoing Phase 3 clinical trial investigating emixustat hydrochloride (“emixustat”) in patients with macular atrophy secondary to Stargardt disease.
The study is a multi-center, randomized, double-masked, and placebo-controlled phase 3 clinical study in which subjects are randomly assigned to emixustat 10 mg or placebo (2:1 ratio) once daily for 24 months. The target total number of subjects was 162; however, due to high interest in the study, a total of 194 subjects were enrolled in this study across 29 sites in 11 countries worldwide. The primary objective of this study is to determine if emixustat reduces the rate of macular atrophy progression, in comparison to placebo, in subjects with Stargardt disease. Secondary objectives include assessing changes in visual function parameters such as BCVA (best-corrected visual acuity) letter score and reading speed.
Ryo Kubota, MD, PhD, Chairman, President and CEO of Kubota Vision Inc., stated, “Stargardt disease is one of the rare diseases with unmet medical needs, and many pharmaceutical companies, including larger ones, are devoting time to drug development for rare diseases.” Dr. Kubota continued, “We believe that this clinical trial adds value by accelerating rare disease therapy development. We are so grateful for all who are involved in this study, including patients, their families and friends, physicians and staff members.”
The FDA (U.S. Food and Drug Administration) and European Medicines Agency (EMA) granted orphan drug designation to emixustat for the treatment of Stargardt disease. (See January 5, 2017 press release titled “Acucela Receives Orphan Drug Designation from the FDA for the Treatment of Stargardt Disease” and June 9, 2019 press release titled “Acucela Receives Orphan Designation from the EMA for Emixustat for the Treatment of Stargardt Disease”)
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