R-Tech Ueno, a Japan-based bio venture company, has begun patient enrolment in a Phase III study of Unoprostone (UF-021) ophthalmic solution to treat retinitis pigmentosa.
The multicentre, randomised, placebo-controlled study is being carried out at 38 sites across Japan is expected enrol 180 patients.
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The 52-week study for efficacy is followed by a 52-week open trial study of UF-021 to assess safety.
R-Tech Ueno president Dr Yukihiko Mashima said retinitis pigmentosa is a hereditary retinochoroidal disease that could lead to progressive night blindness and visual field constriction in addition to 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," Mashima said.
"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 I study of Unoprostone ophthalmic solution was completed in 2008, and a Phase II study was completed in February 2010, in which entral retina sensitivity improvement was observed in a number of patients.
Image: Fundus of patient with retinitis pigmentosa, mid stage.. Photo: Courtesy of Christian Hamel.
