Resolvyx reports positive results for phase 2 study of novel compound for treating dry eye

BEDFORD, Mass. — Resolvyx Pharmaceuticals announced positive data from a phase 2 clinical trial evaluating the safety, efficacy and tolerability of a resolvin when administered as a topical eye drop for treating patients with chronic dry eye syndrome, according to a press release from the company.

The drug, called RX-10045, is a preservative-free synthetic analog of the resolvin RvE1 that has demonstrated potent anti-inflammatory and cell-survival potential in laboratory testing and preclinical trials in dry eye. These phase 2 results represent the first report of efficacy for the novel class of resolvin compounds.

The randomized, multicenter, placebo-controlled, 28-day study examined three doses of RX-10045 when administered twice-daily among 232 patients with moderate dry eye.

In the study, RX-10045 demonstrated dose-dependent, statistically significant improvements for reducing the signs and symptoms of dry eye and demonstrated superiority to placebo on the primary endpoint of worst symptom score (P < .02), as well as on several individual symptoms of the disease. The investigators reported that the onset of symptom relief began within the first week of treatment and continued to improve throughout the 28-day study, signifying the drug's potential for sustaining symptom relief over longer periods of time.

"The results of this study will help Resolvyx design the pivotal trials for RX-10045, which are currently targeted to begin in the first half of 2010," Greg Weinhoff, executive chairman of Resolvyx, said in the release. "In addition to demonstrating the potential of RX-10045 to treat dry eye patients, this study also shows the potential of the entire resolvin class to treat a range of inflammatory diseases."