Positive results in Phase III trial of OMS 302 (Omeros Corporation) in patients undergoing Cataract Surgery

In the second of two pivotal Phase III clinical trials evaluating OMS 302, from Omeros Corporation, in patients undergoing intraocular lens replacement surgery for Cataracts, OMS 302 met its co-primary endpoints by demonstrating statistically significant maintenance of intraoperative mydriasis (pupil dilation) and statistically significant reduction of pain in the early postoperative period. Mydriasis is critical to the safety and surgical ease of lens replacement surgery as intraoperative pupil constriction increases the risk of injury to intraocular structures and can substantially prolong surgical time.

OMS 302 also achieved statistical significance in other clinically relevant measures. The results from this trial are consistent with those from Omeros' first OMS 302 Phase III and earlier Phase IIb clinical trials. With positive data from both trials in the OMS 302 Phase III clinical program, Omeros plans to submit a New Drug Application (NDA) with the FDA in the first half of 2013 and a Marketing Authorization Application (MAA) with the European Medicines Agency in mid-2013, potentially allowing sales in 2014.