R-Tech Ueno enrolls retinitis pigmentosa patients in Phase 3 clinical study of UF-021 ophthalmic solution

Mar 18 2013

R-Tech Ueno (JASDAQ:4573) is pleased to announce the start of the patient enrollment 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.

“Research Study Group Regarding Retinochoroidal and Optic Atrophy”

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.

The president of R-Tech Ueno, an ophthalmologist, Yukihiko Mashima, MD, PhD commented as follows.
"I have seen many patients suffering from intractable diseases for many years as an ophthalmologist. Among these diseases, retinitis pigmentosa is a hereditary retinochoroidal disease, possibly resulting in progressive night blindness and visual field constriction as well as severe visual loss or blindness at the end stage of the disease. Although the disease is designated as an intractable disease by the national government, appropriate therapeutic drugs or therapeutic methods have not been established yet. Therefore, I longed to develop the first therapeutic drug for unmet medical needs, and I planned to develop a therapeutic drug for retinitis pigmentosa since immediately after participating in R-Tech Ueno (in April 2005).

A Phase 1 clinical study with Unoprostone ophthalmic solution was completed in 2008, and a Phase 2 clinical study was completed in February 2010. As a result, promising results were obtained leading to an increase in the number of the patients whose central retina sensitivity improved.
I am very glad that the first registration of the last stage, a Phase 3 clinical study, has been reached now. This study will be conducted with the strong support of many ophthalmologists, the patients and their family in addition to the governmental support of the Japan Science and Technology Agency (JST). R-Tech Ueno will make best efforts to rapidly complete the registration and to deliver this new therapeutic drug to the many patients who have long awaited this treatment."

As a result of the above, there are no changes to the business forecasts throughout the year that were published on February 12, 2013.

SOURCE R-Tech Ueno, Ltd.