Eye Therapy Moves into Clinical Trials

A novel ophthalmic solution from R-Tech Ueno (Tokyo, Japan) made using Novozymes Biopharma’s recombinant human albumin has recently obtained FDA approval to undergo Phase I/II clinical trials in the United States. The solution, RU-101 is being trialled as a therapy for severe dry eye, for which no effective treatment is currently available. The recombinant human albumin is part of Novozymes Biopharma’s albumin range.

The prevalence of severe dry eye, where patients suffer from instability of the tear film, continues to increase. It is the most diagnosed of all ophthalmic disorders and estimates put the market at approximately 1.5 billion USD. The trials for RU-101 ophthalmic solution will move ahead in two stages, the first of which will assess safety using a placebo control, and allow confirmation of the maximum dose. The second stage will then use this maximum dose for 12 weeks to evaluate the safety and effectiveness of RU-101 ophthalmic solution.

Dermot Pearson, Marketing Director at Novozymes Biopharma said, “Novozymes is dedicated to supporting our customers in the drug development and testing stages, and in assisting with the optimisation of their pathways through regulatory approval procedures. We are therefore delighted that RU-101 ophthalmic solution has been approved for clinical testing.”