RegeneRx Biopharmaceuticals is set to begin a Phase II clinical trial of RGN-259 in 72 patients with dry eye syndrome.
RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications.
RegeneRx has recently completed two animal studies showing RGN-259’s positive effects on dry eye symptoms, and has positive human data indicating its ability to heal corneal ulcers.
Based on the earlier results, RegeneRx is conducting a double-masked, placebo-controlled Phase II trial to evaluate the safety and efficacy of RGN-259 against a placebo.
The study will measure the degree of ocular surface damage, ocular itching, burning and inflammation during the treatment period.
The company anticipates enrolment of the first patients in August and expects preliminary data from the study to be available in October 2011.