Omeros initiates OMS302 Phase 3 trial in intra-ocular lens replacement surgery

Oct 11 2011

Omeros Corporation (NASDAQ: OMER) today announced that the first patients have been treated in the Company's Phase 3 clinical program evaluating OMS302 in intra-ocular lens replacement surgery. OMS302, one of Omeros' proprietary PharmacoSurgery™ products, is added to standard irrigation solution used during cataract and other lens replacement surgery to maintain intraoperative mydriasis (pupil dilation) and reduce postoperative pain and inflammation.

This Phase 3 clinical program is enrolling both cataract surgery and refractive lens exchange patients. Two randomized, double-blind, placebo-controlled, multicenter trials are planned. The first trial is underway in North America, and data are expected in the first quarter of 2012.  Omeros plans to initiate the second trial following discussions with regulators to ensure that data collected meet European expectations for marketing approval. The co-primary endpoints for these trials – maintenance of intraoperative pupil dilation (mydriasis) and reduction of postoperative pain – are the same as those achieved in the recently completed 221-patient Phase 2b trial.

"OMS302 has the potential to represent a significant advance for both ophthalmologic surgeons and their patients," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "The pace of enrollment to date has exceeded our expectations, and we look forward to announcing data from this program early next year."