SEATTLE, Aug. 26 Omeros Corporation today announced thepublication of the results from a Phase 1/Phase 2 trial investigating OMS103HPin arthroscopic anterior cruciate ligament (ACL) reconstruction surgery.OMS103HP is an investigational drug product that is added to arthroscopicirrigation solution and is designed to improve postoperative knee function andmotion, reduce postoperative pain and allow patients an earlier return towork. The article titled "Novel Drug Product to Improve Joint Motion andFunction and Reduce Pain After Arthroscopic Anterior Cruciate LigamentReconstruction" appeared in the June 2008 edition of Arthroscopy: The Journalof Arthroscopic and Related Surgery.
The article reports on a prospective, double-blind, vehicle-controlledstudy of 30 evaluable patients undergoing arthroscopic allograft ACLreconstruction. Patients were randomized across two arms to receive eitherstandard arthroscopic irrigation solution or the same solution with OMS103HPadded to it. Patients were monitored for safety, and efficacy endpointsassessed over the 30-day postoperative period included measurements of kneefunction and motion, leg muscle strength, pain and return to work.
Results of the study demonstrated a statistically significant improvementin knee function, range of motion, quadriceps and hamstring muscle strength,pain management and return to work in OMS103HP-treated patients. The incidenceof adverse events and abnormal clinical laboratory values for OMS103HP and thecontrol arm were similar.
"We are pleased that Arthroscopy, a well-respected and peer-reviewedjournal, chose to publish these clinical results obtained using OMS103HP, themost clinically advanced of our PharmacoSurgery product candidates," saidGregory A. Demopulos, M.D., Chairman and CEO of Omeros. "We look forward tocompleting our ongoing Phase 3 clinical program further evaluating the safetyand efficacy of OMS103HP."
OMS103HP is a proprietary combination of active pharmaceutical ingredientswith known anti-inflammatory, analgesic and vasoconstrictive activities. Ifapproved, OMS103HP will be the first commercially available drug product forthe improvement of function following arthroscopic surgery.
About Omeros Corporation
Omeros Corporation is a clinical-stage biopharmaceutical company committedto discovering, developing and commercializing products focused oninflammation and disorders of the central nervous system. Omeros' mostclinically advanced product candidates are derived from its proprietaryPharmacoSurgery(TM) platform designed to improve clinical outcomes of patientsundergoing arthroscopic, ophthalmological, urological and other surgical andmedical procedures. Omeros has four ongoing PharmacoSurgery(TM) clinicaldevelopment programs, and its lead product candidate, OMS103HP, is beingevaluated in Phase 3 clinical trials for use during arthroscopic surgery toimprove postoperative joint function and reduce postoperative pain. Omeros isalso building a diverse pipeline of preclinical programs targetinginflammation and central nervous system disorders. For more information onOmeros, visit the Company's Web site at www.omeros.com.
SOURCE Omeros Corporation