Omeros initiates enrollment in OMS302 Phase 2b clinical trial in patients undergoing cataract surgery

Jul 27 2010

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 receive a placebo of standard irrigation solution without drug. The co-primary endpoints of the study include the reduction of post-operative ocular pain and maintenance of mydriasis (pupil dilation). For more information regarding this trial, please view the study listing at www.clinicaltrials.gov. Positive results from this Phase 2b trial would enable Omeros potentially to initiate a Phase 3 clinical program of OMS302 in 2011.

A prior Phase 1/Phase 2 clinical trial of 61 patients undergoing age-related cataract extraction with lens replacement showed that patients treated with OMS302 reported less postoperative pain and demonstrated statistically significant improvement in maintenance of mydriasis during the surgical procedure compared to patients treated with vehicle control. There were no serious adverse events and no discontinuations due to adverse events.