Phase III trial of OMS 103HP (Omeros Corp) shows pain reduction in patients after arthroscopic Surgery

New results from the first pivotal Phase III clinical trial evaluating OMS 103HP, from Omeros Corporation, in patients undergoing arthroscopic partial meniscectomy Surgery shows the drug provides significant reduction in pain. The trial's primary endpoint was the Symptoms Subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) � a patient-reported measure comprised of questions about knee swelling, clicking, catching and stiffness. In addition, pain measured in the early postoperative period was a secondary endpoint.

Although the Symptoms Subscale of the KOOS did not reach statistical significance, OMS 103HP achieved statistically significant (p=0.0003) reduction of postoperative pain. OMS 103HP also demonstrated improvement across pain-related assessments including postoperative narcotic usage (with more than twice as many OMS103HP-treated subjects taking no postoperative narcotics), incidence of inflammatory adverse events, tourniquet use, and crutch use as well as time to discontinuation of crutches and return to work. In this study OMS103HP was well tolerated. "The data from this trial are compelling and demonstrate the benefits of preemptive and multimodal treatment during surgery," states William E. Garrett, Jr. professor of orthopaedic surgery and team physician at Duke University.