Unoprostone in Phase III study for RP

Article

Unoprostone will begin patient enrolment for the Phase III clinical study for the treatment of retinitis pigmentosa (RP), claims the latest press release.

Unoprostone will begin patient enrolment for the Phase III clinical study for the treatment of retinitis pigmentosa (RP), claims the latest press release.

The UF-021 ophthalmic solution will undergo a randomized, double-masked controlled study for 52 weeks to assess efficacy on 180 patients. An additional open trial study on the safety of unoprostone will be conducted for a further 52 weeks at 38 sites.

Dr Yukihko Mashima, president of R-Tech Ueno, commented, "A Phase I clinical study with Unoprostone ophthalmic solution was completed in 2008, and a Phase II 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 III clinical study, has been reached now," continued Dr Mashima. "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."

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