TOKYO--(BUSINESS WIRE)--R-Tech Ueno (JASDAQ: 4573) announced today the end of a Phase 3 clinical study with Unoprostone (development code UF-021) ophthalmic solution that are being developed in our company for the treatment of retinitis pigmentosa and the preliminary Findings from a Phase 3.
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, was 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 was 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 was 180 patients and the study was carried out at 38 sites nationwide.
The primary endpoint of the study was the changes in the value of the mean retinal sensitivity at four central points through HFA (10-2). The difference compared to the placebo group was not statistically significant.
However, the primary endpoint and visual acuity of UF-021 group demonstrated improvement compared to Day 0 (before the study) and the difference was statistically significant. On the other hand, the Goldmann visual field of the placebo group progressed statistically and significantly the constriction of the visual field compared to Day 0. Furthermore the total score of VFQ-25 was found to have improved statistically and significantly in the UF-021 group.
We confirmed the therapeutic effectiveness of UF-021 ophthalmic solution for Retinitis Pigmentosa through the present Phase 3 clinical study in Japan, but as the primary endpoint at the end of study was not statistically significant, we are analyzing the data from various angles and examining possibility of the new drug application to MHLW as best we can now. And we decided to close the open trial study of UF-021 for a further 52 weeks for safety in the view of objectivity of the data obtained.
Regarding the impact of this matter on the company’s full-year results, no changes are to be made on the full-year business result forecasts released on February 12, 2015.
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