R-Tech Ueno has started patient enrolment in Phase I/II study of recombinant human serum albumin-containing ophthalmic solution (development code: RU-101) in the US for treating severe dry eye.
The company is developing RU-101 ophthalmic solution to treat severe dry eye, which has no established effective treatment.
R-Tech Ueno ophthalmologist and the president Yukihiko Mashima said initial cases have been enrolled in a Phase I/II clinical study of RU-101 ophthalmic solution in US.
"The enrolment launched immediately after the approval of our IND application by FDA, reflecting the high medical needs," Mashima said.
The first stage of the two-stage trial will mainly assess the safety using placebo (without the active ingredient) as a control to evaluate maximum dosage of RU-101 ophthalmic solution for treatment of patients with severe dry eye.
The next stage will assess RU-101 ophthalmic solution of maximum dosage safety, which will have been confirmed at the first stage, and will be instilled for 12 weeks. The safety and effectiveness will be evaluated using a placebo as control.
The trial that is performed as a double masking test at each stage will include a maximum 120 study subjects in the first and second stage studies in ten US medical facilities.