R-Tech Ueno has begun enrolling patients with severe dry eye in Phase I/II study of recombinant human serum albumin-containing ophthalmic solution (development code: RU-101) in US.
The two-stage trial is performed as a double masking test at each stage.
It will include around 120 study subjects in the first and second stage studies.
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 enrollment launched immediately after the approval of our IND(Note 3) application by FDA(Note 4), reflecting the high medical needs, I think," Mashima added.
The first stage will mainly assess the safety 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.
The next stage will assess 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.
