R-Tech Ueno: Start of the Patient Enrollment of a Phase 3 Clinical Study of Unoprostone (Development Code UF-021) Ophthalmic Solution for the Treatment of Retinitis Pigmentosa
Published: Mar 18, 2013
TOKYO--(BUSINESS WIRE)--R-Tech Ueno (JASDAQ:4573) is pleased to announce the start of the patient enrollment of a Phase 3 clinical study with Unoprostone(note 1) (development code UF-021) ophthalmic solution that are being developed in our company for the treatment of retinitis pigmentosa(note 2). The Phase 3 clinical study with UF-021 ophthalmic solution for treatment of retinitis pigmentosa (ClinicalTrials.gov Identifier:NCT01786395), for which an effective therapy has not been currently established, is a multicenter study using a placebo (without the active ingredient) as a control carried out based on Good Clinical Practice (GCP) in patients with visual field constriction and then deterioration of vision. This is a randomized double-masked controlled study for 52 weeks for efficacy, followed by the open trial study of UF-021 for a further 52 weeks for safety. The target sample size is 180 patients and the study is being carried out at 38 sites nationwide.