Notification Related to the Completion of the Phase II Clinical Study of UF-021 (Product Name Ocuseva (TM) ) on Retinitis Pigmentosa
TOKYO, June 3 /PRNewswire/ — We are pleased to announce that the Phase II clinical study of UF-021, product name Ocuseva (TM), which we are developing as a therapeutic drug for retinitis pigmentosa (note 1), has been completed.
Retinitis pigmentosa is an intractable disease where therapeutic drugs or therapeutic methods have not been established yet. When the disease of retinitis pigmentosa progresses, the visual field narrows irreversibly and furthermore, in the late stage, they may suffer from severe visual loss or even blindness. The Phase II clinical study (this study) was conducted to investigate the possibility of improvement of the visual function in the central part of the retina with UF-021 (product name Ocuseva (TM)) in patients whose progression of retinitis pigmentosa was in the mid-stage to the late stage.
This study was a multi-center, randomized, double blind, 3 groups parallel, placebo controlled study conducted based on the Good Clinical Practice (GCP). The groups where the patients placed two dose of UF-021 (Ocuseva (TM)) eyedrops for 24 weeks respectively were compared with the placebo eyedrops (eyedrops without any pharmacological agent) group. The number of enrolled patients was 112.
As a result, it was revealed that UF-021 (Ocuseva (TM)) shows improvement in the visual function dose-dependently in both visual field test and subjective findings. Furthermore, although there was an irritation upon instillation, there were no severe adverse effects.
The study data is currently being analyzed and will be presented at academic conferences and also released through other channels.
(note1) About Retinitis Pigmentosa
Retinitis pigmentosa is a hereditary disease and its prevalence rate is said to be about 1 in 5000 people in the world and 1 in 4000 – 8000 people in Japan. When this number is applied to the population of Japan, 128 million people, the number of patients with retinitis pigmentosa can be estimated as 16,000 – 32,000 people which makes this disease an orphan disease. On the other hand, when projecting the number of patients with retinitis pigmentosa in the world from the world population, 6.75 billion people (2008), it can be estimated as 1.35 million people. When retinitis pigmentosa progresses, patients suffer progressive night blindness, where it becomes difficult to see in dim light, or visual field constriction and then deterioration of vision. In the late stage, they may suffer from severe visual loss or even blindness. It is designated as an intractable disease and appropriate therapeutic drugs or therapeutic methods have not been established at the moment. According to the report by the “Research Study Group Regarding Retinochoroidal and Optic Atrophy”, a specified disease treatment research program of the Ministry of Health, Labour and Welfare (MHLW) in 2005, retinitis pigmentosa is the 3rd cause for impaired vision and especially in patients aged 60 or under it is the leading cause for
Accreditation of Retinitis Pigmentosa as a Specified Disease Some diseases are very difficult to treat, they chronically develop, leave after-effects and make it extremely difficult or impossible for the patient to return to society, require a high medical cost, cause a heavy burden both domestically and mentally such as financial problems and nursing care and furthermore, as they are rare diseases they need to be studied on a nationwide scale. MHLW designates such diseases as intractable diseases. Currently, 130 diseases are designated as intractable diseases. Retinitis pigmentosa is a research target of the clinical research study area of the Research for Overcoming Intractable Diseases, MHLW. Disease number 33. Additionally, among the 130 intractable diseases, 56 are accredited as “specified diseases” and receive public fund assistance for medical expenses. Retinitis pigmentosa is one of the “specified diseases” and is covered by public fund assistance for medical expenses. Diseases subsidized for medical expenses of designated intractable diseases: disease number 37.
Reference: Japan Intractable Disease Information Center
About UF-021eye drops (product name Ocuseva (TM)
R-Tech Ueno, Ltd. is developing Ocuseva (TM), a new type of prescription eyedrop with isopropyl unoprostone as the active ingredient, as a drug of neuroprotection.
About R-Tech Ueno, Ltd.
R-Tech Ueno is a bio venture company established in September 1989 for the purpose of marketing and R&D of drugs. Under leadership of the CEO, 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. We aim at becoming a “global pharmaceutical company specializing in specific fields (ophthalmology and dermatology) and selling and developing pharmaceutical products through the eyes of doctors.” We are promoting development of new drugs of unmet medical needs (medical needs that are not fulfilled yet) which the government recommends and assists, orphan drugs and the drugs in the field of anti-aging (lifestyle drugs).
Stock Code: No.4573, Osaka Securities Exchange; Hercules Head Office: 1-1-7 Uchisaiwai-cho, Chiyoda-ku, Tokyo Representative: Yukihiko Mashima, Representative Director & President Contact: Koji Nakamura Business Management Department TEL: +81-3-3596-8011 e-mail: firstname.lastname@example.org URL: http://rtechueno.com/en/
SOURCE R-Tech Ueno, Ltd.