TOKYO--(BUSINESS WIRE)--R-Tech Ueno (JASDAQ:4573):
This is to announce 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,
has stated as follows:
“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.”
As a result of the above, there are no changes to the business forecasts throughout the year that were published on May 14, 2014.
For full details of the press release, please visit:
http://www.rtechueno.com/en/investor/press/documents/141110_pr_en.pdf
