Japan's R-Tech Ueno failed to meet its primary endpoint in a Phase III clinical trial for Unoprostone (UF-021) ophthalmic solution, the company said in a press release, adding that it is reviewing options for the candidate.
The study covered UF-021 ophthalmic solution for treatment of retinitis pigmentosa, for which an effective therapy has not been currently established in the multicenter study using a placebo.
"We confirmed the therapeutic effectiveness of UF-021 ophthalmic solution for Retinitis Pigmentosa through the present Phase III 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."
- here's the release from R-Tech Ueno (PDF)
- and the study on ClinicalTrials.gov