US based drug developer RegeneRx Biopharmaceuticals has decided to start a placebo-controlled, double-masked Phase 2 trial for evaluating the efficacy and safety of RGN-259 in patients with dry eye syndrome soon.
The trial which will be conducted by ORA, an ophthalmic contract research organization, will start patient enrollment in next month.
In the trial, the patients will be given RGN-259 or placebo twice daily for 30 days.
Previously, RGN-259 has demonstrated reduction in corneal damage associated with dry eye syndrome in two animal models when compared to both positive and negative controls.
RegeneRx president and CEO Finkelstein said they have received Institutional Review Board approval for the trial, completed manufacturing of RGN-259 and placebo, and are currently preparing for enrollment of the first patients.
"This is a very important clinical trial for RegeneRx that is based on a body of human and preclinical data that suggest RGN-259 could have beneficial effects in treating dry eye," Finkelstein said.