RegeneRx Biopharmaceuticals has started patient enrollment in a Phase 2 clinical trial of RGN-259, a sterile, preservative-free topical eye drop for the treatment of patients with dry-eye syndrome.

The 72-patient, double-masked and placebo-controlled clinical trial, conducted by ophthalmic contract research organisation ORA, is designed to evaluate the safety and efficacy of RGN-259.

Patients will receive RGN-259 or a placebo twice daily for 30 days.

The efficacy endpoints include degree of ocular surface damage, ocular itching, burning and grittiness.

RegeneRx expects to complete the study by September, with preliminary data scheduled to be available in October 2011.

In animal models, RGN-259 has been shown to reduce ocular surface defects associated with dry-eye syndrome when compared to both positive and negative controls.

The first patient treated with RGN-259, who had a non-healing corneal wound 23 days after surgery, healed within 11 days after treatment with RGN-259 and six patients with neurotrophic corneal epithelial defects either completely healed or substantially healed within the treatment period.