Omeros Corp. (OMER) Thursday reported results from its first pivotal Phase 3 trial evaluating OMS103HP in patients undergoing arthroscopic partial meniscectomy surgery.
The double-blind Phase 3 trial compared OMS103HP with vehicle control in 344 subjects, and its pre-specified primary endpoint was the Symptoms Subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) - a patient-reported measure that is comprised of questions about knee swelling, clicking, catching and stiffness. In addition, pain measured in the early postoperative period was a pre-specified secondary endpoint.
Although the Symptoms Subscale of the KOOS did not reach statistical significance, OMS103HP achieved statistically significant reduction of postoperative pain. The pain reduction data were similar in magnitude to those in the Phase 2 clinical trial.
OMS103HP also demonstrated improvement across a series of 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, a number of which also achieved statistical significance.
In this study, as in the earlier clinical trials, OMS103HP was well tolerated.
Given the strength and consistency of the data in this Phase 3 clinical trial, Omeros said its second OMS103HP Phase 3 trial remains on track and will begin in the first half of 2013.
OMS103HP, added to standard irrigation solution used during arthroscopy, is Omeros' proprietary PharmacoSurgery product designed to provide a multimodal approach to reduce pain and inflammation following arthroscopic surgery.
Results from this first Phase 3 arthroscopic meniscectomy clinical trial are expected to be presented at an upcoming major orthopedic sports medicine meeting. Omeros also plans to publish the results in a leading peer-reviewed arthroscopy journal.
by RTT Staff Writer
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