R-Tech Ueno, Ltd. has started patient enrollment of  the first stage of a phase I/II  clinical study of recombinant human serum albumin-containing ophthalmic solution (development code: RU-101; hereafter RU-101 ophthalmic solution), in US for the treatment of severe dry eye.

The trials consist of two stages. At the first stage, the safety will be mainly assessed using placebo (without the active ingredient) as control to evaluate maximum dosage of RU-101 ophthalmic solution for treatment of patients with severe dry eye. At the next stage, RU-101 ophthalmic solution of maximum dosage safety of which will have been confirmed at the first stage will be instilled for 12 weeks, and the safety and effectiveness will be evaluated using placebo as control.

The trial will be performed as a double masking test at each stage. Maximum 120 study subjects will be totally involved in the first and second stage studies in 10 US medical facilities.

Yukihiko Mashima MD, PhD, an ophthalmologist and the president of R-Tech Ueno, said, “I am very pleased that initial cases have been enrolled in a phase I/II clinical study of RU-101 ophthalmic solution in US. The enrollment launched immediately after the approval of our IND application by FDA, reflecting the high medical needs, I think. Dry eye is a modern disease which reportedly one of three office workers suffers. Our target, market for dry eye, is estimated to be 1,500 million USD, which is still increasing. We will promote the development of the drug for moderate to severe dry eye, an unmet medical need where no sufficient treatment method has been established. We attempt to rapidly complete the case enrollment with cooperation of people such as ophthalmologists and patients and promote the first stage study. Also, we will start the second stage as soon as possible and aim rapid approval of this solution for patients with dry eye who need the solution.”

Mashima further added, “We are currently developing RU-101 ophthalmic solution to treat severe dry eye for which no effective treatment has been established.”

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.

To avoid the effect of a placebo (effect of an assumption), study is performed without informing both medical doctors and patients (subjects) of which is effective ‘solution’ and non-effective ‘placebo’. The term means that all those involved such as subjects, medical doctors, clients, and other staffs who work on the treatment and clinical assessment in the facility do not know which solutions, true drug or placebo, are administered to the subjects.

To perform clinical trial in United States, it is necessary to submit an information package which includes active pharmaceutical ingredients, drug formulation, non-clinical study, and design of the clinical study regarding the novel candidate drug to FDA, and obtain the approval to perform the clinical trial. The candidate drug itself and/or submitted information package are called IND (Investigational New Drug).

R-Tech Ueno is a bio venture company established for the purpose of R&D and marketing of drugs.