TOKYO
R-Tech Ueno, Ltd. (JASDAQ:4573):
We are now pleased to announce the completion of Stage I of the Phase I/II clinical trial (hereinafter called this trial) of recombinant human serum albumin-containing ophthalmic solution (development code: RU-101Note 1; hereafter RU-101 ophthalmic solution), which is being developed in our company, in the United States for the treatment of severe dry eye. RU-101 ophthalmic solution, and the commencement of enrollment for Stage II.
At present, we are in the process of developing RU-101 ophthalmic solution for patients with severe dry eye for which no effective ophthalmic solution treatments are available.
This trial consists of two stages: In Stage I, the safety of RU-101 ophthalmic solution was mainly evaluated by using placebo (a treatment without any active drug) as the control to understand to what extent the dose of RU-101 ophthalmic solution can be increased in patients with severe dry eye. In Stage II, the efficacy and safety of RU-101 ophthalmic solution will be evaluated by administering RU-101 ophthalmic solution at the maximum dose for which safety has been established in Stage I, for 12 weeks using placebo as the control. Since Stage I, which established the safety of RU-101 ophthalmic solution, has been completed, enrollment for Stage II has started.
Yukihiko Mashima MD, PhD, an ophthalmologist and the president of R-Tech Ueno, said “I am pleased that the Phase I/II clinical trial of RU-101 ophthalmic solution is progressing satisfactorily in the United States. Hereafter, with the cooperation of various parties including ophthalmologists and patients, we will promptly conduct Stage II, aiming for early approval for the sake of patients with dry eye who are in need of this medicine.”
(Note1) About RU-101
RU-101 is a project that is aimed at the development of ophthalmic solutions for the treatment of corneal epithelial diseases including dry eye, focusing on serum component albumin. Dry eye is a chronic and multifactor ophthalmic disease characterized by disorders of the lacrimal layer and the eye surface. R-Tech Ueno has confirmed that serum albumin enhances the production of mucin, one of the components of tears, in an experiment in conjunctival epithelial cells, and also has intellectual property rights concerning the treatment of dry eye with albumin.
About R-Tech Ueno, Ltd.
R-Tech Ueno is a bio venture company established in September 1989 for the purpose of R&D and marketing of drugs. Under the 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 developing and selling pharmaceutical products through the eyes of doctors.” We are promoting the development of new drugs for unmet medical needs for which the government provides recommendations and assistance, orphan drugs and the drugs in the field of anti-aging (lifestyle drugs).
CONTACT
R-Tech Ueno, Ltd.
Koji Nakamura, +81-3-3596-8011
Director
Business
Management Department
info@rtueno.co.jp
