We are pleased to announce that subject enrollment for the phase 2 clinical study of 0.15% UF-021 (generic name; isopropyl unoprostone; active ingredient of Rescula(R) eye-drops) in patients with retinitis pigmentosa has been completed.
We submitted the notification of the clinical trial in August 2008. Enrollment in the phase 2 study began at six clinical sites in late December 2008 and was completed on August 3, 2009.
The clinical study has progressed with no delay, no serious adverse effects, and only a few cases of discontinuation so far. Hereafter, we expect to complete the study by next spring, including data collection and analysis.
Retinitis pigmentosa is a progressive hereditary disease affecting nearly 50,000 people in Japan, which is characterized by night blindness. Patients generally suffer from peripheral visual field loss and low vision in the late stage of the disease. At present, there is no effective treatment for this disease.
We developed and launched isopropyl unoprostone eye-drops on the market as a drug for glaucoma and ocular hypertension in 1994. In recent studies on isopropyl unoprostone, the drug has been reported to present neuroprotective effects and a function to improve ocular circulation. Studies at some university hospitals have also suggested that isopropyl unoprostone eye-drops improve symptoms of retinitis pigmentosa or stop the progression of the disease.
We expect isopropyl unoprostone to become a unique drug for improvement of the quality of vision in patients with retinitis pigmentosa.