MAR 18, 2013
Japanese drugmaker R-Tech Ueno has begun enrollment for a phase 3 clinical study of unoprostone isopropyl ophthalmic solution, an eyedrop for treating retinitis pigmentosa.
Originally developed as a glaucoma treatment, early human studies show the drug has potential for treating retinitis pigmentosa as well as AMD. Investigators say unoprostone works by slowing apoptosis and may also improve blood flow to the retina.
Subjects receiving the highest dose in early trials were more likely than those receiving placebo to have significant improvement in their night-time and dim-light vision. They were also more likely to report improvements in their "social life functions due to vision."
Early trials also show it may protect vision from further deterioration. During the six-month study, 21.2 percent of people receiving the placebo lost some visual sensitivity, whereas only 2.6 percent of those on the highest dose lost any sensitivity.
The phase 3 trial getting underway is a randomized, multi-center, double-masked, placebo-controlled study evaluating the efficacy and safety of unoprostone in 180 patients.
Additionally, an early phase 2 trial testing unoprostone in people with dry AMD is now underway in Europe.