Resolvyx announces completion of FDA review period for dry eye drug

The opening of this investigational new drug (IND) application, submitted in early October 2008, allows Resolvyx to initiate its first clinical trial, which will be a placebo-controlled, Phase I/II study of RX-10045 in 200 patients with moderate-severe dry eye. The company will initiate this study before the end of 2008.

RX-10045 is an isopropyl ester pro-drug of the active Resolvin compound, RX-10008. Resolvyx said that it has conducted in vivo preclinical studies that have demonstrated that RX-10008 is effective in preventing the deleterious effects of dry eye as well as restoring healthy cell function.

In addition, RX-10008 has been shown to be highly effective in preventing clinical signs of dry eye, including decreasing corneal inflammation, reducing corneal epithelial damage and preventing loss of goblet cells (the cells responsible for maintaining tear film integrity).

Paul Rubin, CEO of Resolvyx, said: “We are excited that RX-10045 has reached this important milestone, as the first IND application for a resolvin therapeutic and our company’s lead clinical candidate. We are moving aggressively to start this Phase I/II trial. RX-10045 has promise as a novel therapeutic approach for the treatment of this extremely prevalent disorder for which there is clearly a need for effective drugs.”