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Omeros Enrolls First Patient in Phase 2b Clinical Trial Evaluating OMS302 in Patients Undergoing Cataract Surgery

Tue, 07/27/2010 - 4:35am
Bio-Medicine.Org

SEATTLE, July 27 /PRNewswire-FirstCall/ -- Omeros Corporation (Nasdaq: OMER), a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced that it has enrolled the first patient in its Phase 2b clinical trial evaluating OMS302 in patients undergoing cataract surgery.  OMS302, added to standard irrigation solution used during ophthalmologic surgery, is Omeros' proprietary PharmacoSurgery™ product in development to maintain mydriasis (pupil dilation) and reduce postoperative pain and inflammation following cataract and other lens replacement surgery.

"Building on the solid foundation of the Phase 1/Phase 2 OMS302 data reported last year, we are pleased to enroll the first patient in our Phase 2b trial, which is using a full-factorial design to compare the individual agents in OMS302 to the proprietary drug product itself," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "There are over three million cataract procedures performed annually in the U.S. alone, and OMS302 has the potential to maintain pupil dilation, making the operation easier for the surgeon and safer for the patient, and to reduce postoperative inflammation, improving patient outcomes."

Approximately 200 patients will be enrolled in the multicenter, randomized, double-blind, vehicle-controlled Phase 2b clinical trial. Patients will be randomized into one of four parallel treatment groups of equal size. The first arm will receive OMS302, the second and third will receive only the mydriatic agent and the anti-inflammatory agent, respectively, and the fourth arm will

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