Omeros initiates enrollment in second Phase 3 trial of OMS302

Apr 10 2012

Omeros Corporation (NASDAQ: OMER) today announced that patient enrollment has begun in the Company's second Phase 3 clinical trial evaluating OMS302 in intraocular lens replacement (ILR) surgery. OMS302, one of Omeros' proprietary PharmacoSurgery™ products, is added to standard irrigation solution used during ILR procedures to maintain intraoperative mydriasis (pupil dilation) and reduce postoperative pain. In the first Phase 3 clinical trial of OMS302, the drug product demonstrated statistically significant superiority over placebo in maintenance of intraoperative mydriasis (p<0.00001) and reduction of postoperative pain (p<0.00001).

Like the initial Phase 3 clinical trial, this second Phase 3 trial will enroll approximately 400 patients undergoing cataract surgery or refractive lens exchange. Randomized, double-blind, placebo-controlled and multicenter, this trial will evaluate the same efficacy and safety measures as the earlier successful Phase 2b and Phase 3 clinical trials.  Data are expected in the second half of 2012.

"Given the strength and consistency of the data from the earlier Phase 2b and Phase 3 clinical trials of OMS302, we look forward to reporting results from our second Phase 3 trial later this year," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "Our previous OMS302 trials enrolled rapidly, and we expect a similar enrollment rate in this trial.  We have begun preparing our NDA and, assuming positive data, are targeting a submission date in the first part of 2013."