Isopropyl unoprostone: Additional Phase II data

Additional data from a double-blind, Japanese Phase II trial in 112 patients showed that twice-daily 2-drop per 5-minute interval dosing of a 0.15% formulation of UF-021 met the secondary endpoint of significantly improving retinal sensitivity from baseline to week 24 after adjusting for baseline retinal sensitivity as measured by differential light sensitivity in the visual field using Humphrey perimeter vs. placebo (p<0.05). Twice-daily 1-drop per 5-minute interval dosing of UF-021 missed the endpoint. Both 1- and 2-drop doses missed the secondary endpoint of significantly improving retinal sensitivity as measured by the William's Test, which compares multiple dose groups to a 0-dose group control (p=0.167 and p=0.053, respectively).

Additionally, the 2-drop dose met the secondary endpoint of significantly reducing the proportion of patients who had a reduction in retinal sensitivity of >=4 decibels vs. placebo (2.6% vs. 21.1%, p=0.02), whereas the 1-drop dose missed the endpoint (15.8%). For this endpoint, retinal sensitivity was measured by stimulating several points of the retina by a series of light intensities, and subsequently measuring the retinal response to the light in decibels. The 2-drop dose also met the secondary endpoint of significantly improving vision-related social function of the NEI-VFQ-25 test vs. placebo (p=0.001), as well as NEI-VFQ-25 total score at week 24 (p<0.05). ...