R-Tech Ueno Completes Subject Enrollment in Phase 2 Clinical Study of 0.15% UF-021
TOKYO, Aug. 25 /PRNewswire/ — 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.
About R-Tech Ueno, Ltd.
R-Tech Ueno was established in September 1989 for the purpose of marketing and R&D of drugs. Under the leadership of the president, also a medical doctor, the company is developing new drugs on the theme “Physician-Oriented New Drug Innovation,” targeting ophthalmologic and dermatologic diseases that previously had no effective therapeutic agent.
The company’s main product Rescula(R) eye-drops 0.12% is a therapeutic drug for glaucoma and ocular hypertension and has been marketed in Japan since 1994. R-Tech Ueno was the first in the world to take advantage of the substance “prostone” in the development of Rescula(R). Prostone was discovered in 1980 by Dr. Ryuji Ueno, the founder of the company.
Rescula(R) eye-drops 0.12% that causes less topical and systemic adverse reactions, demonstrates steady ocular pressure decreasing action by twice-a-day instillation. Such excellent therapeutic effects are realized through its optic nerve protection and ocular blood flow-increasing mechanism.
Concerning Rescula(R) (isopropyl unoprostone) for the treatment of glaucoma and ocular hypertension, R-Tech Ueno concluded a contract with Sucampo Pharma Americas, Inc. in April 2009 for the approval and assignment of distributorship, as well as for licensing the relevant patents and granting exclusive right to manufacture and supply in the USA and Canada.
Representative Director & President: Yukihiko Mashima Head Office: 1-1-7 Uchisaiwai-cho, Chiyoda-ku, Tokyo Code No.4573, Osaka Securities Exchange; Hercules Contact: Koji Nakamura Business Management Department R-Tech Ueno, Ltd. Tel: +81-3-3596-8011 e-mail: email@example.com
SOURCE R-Tech Ueno, Ltd.