R-Tech Ueno, a bio venture company, announced the completion of a phase I/II clinical study of recombinant human serum albumin-containing ophthalmic solution (development code: RU-101) for the treatment of severe dry eye.
The design of this study was a placebo (without the active ingredient) controlled, double-masked study in severe dry eyes patients in the United States to confirm the safety and initial efficacy of RU-101 ophthalmic solution in two stages. Using the RU-101 ophthalmic solution of maximum dosage safety of which had been confirmed at Stage I (equivalent to phase I), the safety and effectiveness were evaluated in the Stage II (equivalent to early phase II) in 104 patients (RU-101 ophthalmic solution, 52 patients; placebo ophthalmic solution, 52 patients). The corneal staining score after 12-week administration was used as a primary endpoint for the effectiveness. No safety issue was found for RU-101 ophthalmic solution throughout the two stages.
Administration of RU-101 ophthalmic solution significantly improved the corneal staining score time-dependently and statistically for 4, 8, and 12 weeks after starting instillation. However, no significant difference between RU-101 and placebo was noticeable in the score after 12 weeks of instillation because the score improved similarly in the placebo group as well. Nevertheless, the RU-101 instillation group tended to show a greater improvement after 4 and 8 weeks than the placebo group, and the improvement was particularly remarkable in patients with more severe dry eyes. In addition, results from evaluation with the conjunctival staining score, a secondary endpoint, were similar to those from corneal staining score-based evaluation.
Yukihiko Mashima MD, an ophthalmologist and president of the company, said: “We successfully confirmed the therapeutic effectiveness of RU-101 ophthalmic solution for severe dry eyes through the present phase I/II clinical study in the US, despite a relatively small number of patients. This study has also suggested the possibility that RU-101 ophthalmic solution is particularly effective in patients with more severe dry eyes. Based on these results, we will continue to perform the development process, including studies to determine an appropriate frequency and concentration for instillation in patients with severe dry eyes, while keeping an eye on possible out-licensing.”
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 l ayer 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 eyewith albumin.
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.