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Trial establishes safety of RU-101 for dry eye
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R-Tech Ueno Ltd. announced in a press release that stage 1 of a phase 1/2 U.S. clinical trial showed that genetically recombinant human serum albumin is safe for use in patients with dry eye.
The company has now begun enrollment for the stage 2 trial of the agent, RU-101, for treating severe dry eye.
In stage 1, RU-101 ophthalmic solution was evaluated by using a placebo control to determine the maximum dosage of the solution. In stage 2, the efficacy and safety of the solution will be evaluated when administering this maximum dosage for 12 weeks, compared with a placebo control.
Yukihiko Mashima MD, PhD, an ophthalmologist and president of R-Tech Ueno, said in the press release that the company will “promptly conduct stage 2, aiming for early approval for the sake of patients with dry eye who are in need of this medicine.”
According to the press release, “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.”