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Enrollment completed for phase 3 study of retinitis pigmentosa treatment
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Sucampo announced that its development partner, R-Tech Ueno, has completed enrollment for a phase 3 study of unoprostone isopropyl ophthalmic solution 0.15% for the treatment of retinitis pigmentosa, according to a news release.
The randomized, double-blind, placebo-controlled study, to be conducted at 38 medical institutions in Japan, will evaluate whether unoprostone isopropyl ophthalmic solution improves central retinal sensitivity in patients with retinitis pigmentosa. The study’s target sample size is 180 patients, according to the release.
The U.S. Food and Drug Administration and the European Medicines Agency have granted orphan drug designation to unoprostone isopropyl for the treatment of retinitis pigmentosa.
The study, funded through an agreement between R-Tech and the Japan Science and Technology Agency, is expected to be completed by the end of 2014, with top-line results expected in early 2015, the release said.