Omeros advances OMS103HP and OMS302 into Phase 3 clinical programs

May 19 2011

Omeros Corporation (NASDAQ: OMER) today announced that it is advancing two of its product candidates from its PharmacoSurgery™ platform – OMS103HP for arthroscopic meniscectomy and OMS302 for intra-ocular lens replacement surgery – into Phase 3 clinical development programs. Both of these product candidates are added to standard irrigation solutions and delivered intra-operatively to the operative site throughout the surgical procedure to preemptively block the molecular-signaling and biochemical cascade caused by surgical trauma and to provide clinical benefits both during and after surgery.

"I am pleased to report today that we have already begun advancing Phase 3 clinical programs for OMS103HP and OMS302," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros.  "Both of these drugs generated positive efficacy and safety data in large Phase 2 clinical trials and, based on our analysis of those data, we are optimistic that each drug's clinical benefits will be further demonstrated in its respective Phase 3 clinical program."

The OMS103HP Phase 3 clinical program will evaluate the drug's safety and efficacy in improving postoperative joint function and reducing pain following arthroscopic partial meniscectomy surgery. The program will consist of two randomized, double-blind, vehicle-controlled, multicenter trials to be conducted in North America and Europe. Omeros expects data from the North American trial in the first half of 2012. The Company is in discussions with European regulatory authorities regarding the second clinical trial and, assuming sufficient resources, plans to begin that trial during the fourth quarter of 2011. The primary endpoint for these trials will be performance on the Knee Injury and Osteoarthritis Outcome Score (KOOS), a validated patient-reported outcomes measure used in the successful Phase 2 meniscectomy trial.

OMS302 will be evaluated for safety and efficacy in patients undergoing intra-ocular lens replacement surgery. The trials will enroll both cataract surgery and refractive lens exchange patients. This clinical program will involve two randomized, double-blind, placebo-controlled, multicenter trials. The first trial will be conducted in North America and data are expected in the first half of 2012.  Omeros will initiate the second trial in Europe following discussions with regulators to ensure that data collected meet European expectations for marketing approval. The co-primary endpoints for these trials – maintenance of intraoperative pupil dilation (mydriasis) and reduction of postoperative pain – are the same as those achieved in the recently completed 221-patient Phase 2b trial.