SEATTLE, Aug. 8, 2012 -- Omeros Corporation (NASDAQ: OMER) today reported the completion of enrollment in the first of two planned Phase 3 clinical trials evaluating OMS103HP in patients undergoing arthroscopic partial meniscectomy surgery. OMS103HP is a proprietary drug product added to standard irrigation solutions and delivered to the operative site throughout arthroscopy to preemptively block the molecular-signaling and biochemical cascade caused by surgical trauma and to improve postoperative functional outcomes.
The Phase 3 clinical program for OMS103HP is assessing the drug's safety and efficacy in improving postoperative joint function and reducing pain following arthroscopic partial meniscectomy surgery. The program is expected to consist of two randomized, double-blind, vehicle-controlled, multicenter trials. The primary endpoint for both trials will be performance on the Knee Injury and Osteoarthritis Outcome Score (KOOS), a validated patient-reported outcomes measure used in Omeros' earlier successful Phase 2 meniscectomy trial.
The last patient enrolled in this Phase 3 clinical trial has undergone surgery and is now participating in the study protocol's postoperative evaluations. Omeros expects to be able to announce data from this trial during the second half of 2012 after those evaluations are complete. Assuming positive data from the current trial, Omeros plans to initiate enrollment in its second Phase 3 meniscectomy trial following discussions with European regulatory authorities.
"With this enrollment milestone achieved, we expect to announce data from three of our clinical programs during the remainder of 2012," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "In addition to wrapping up our Phase 3 OMS103HP trial, our other Phase 3 clinical program – OMS302 for lens replacement surgery – will complete its Phase 3 trial and, if the outcome is positive, we plan to submit both US and EU marketing applications in the first part of 2013. The Phase 1 clinical trial of our PDE10 inhibitor for cognitive disorders also remains on track for 2012 data, and we expect that one or more of our other pipeline programs will advance into the clinic next year."
PR Newswire