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Omeros Corporation
today
reported results from its first pivotal Phase 3 clinical trial evaluating
OMS103HP in patients undergoing arthroscopic partial meniscectomy surgery. In
this multicenter, double-blind, Phase 3 clinical trial comparing OMS103HP to
vehicle control in 344 subjects, the 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 (p=0.0003) 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' second
OMS103HP Phase 3 trial remains on track and will begin in the first half of
2013.
"The data from this Phase 3 trial are compelling and demonstrate the benefits
of preemptive and multimodal treatment during surgery," stated William E.
Garrett, Jr., M.D., Ph.D, professor of orthopaedic surgery and team physician
at Duke University. "Early postoperative pain is predominantly inflammatory
pain, and control of postoperative pain and inflammation is critical to
functional recovery in arthroscopy patients. While OMS103HP demonstrated
positive KOOS data in the Phase 2 trial, the absence of similar data in this
trial does not detract from the drug's therapeutic value in light of its
reduction of inflammatory pain. Arthroscopy patients with significant early
postoperative pain and inflammation generally face a slower and more difficult
recovery."
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.
Inhibiting inflammation and resultant postoperative pain is critical to the
management of arthroscopy patients. Comprised of only anti-inflammatory active
ingredients without any anesthetic agents, such as lidocaine or bupivacaine,
and delivered directly to the joint in the arthroscopic irrigation solution,
use of OMS103HP avoids the frequently reported damage to cartilage cells due
to intraarticular delivery of local anesthetics as well as the detrimental
effects of systemically delivered analgesics.
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.
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