Apr 1 2011
Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, bleeding and disorders of the central nervous system, today reported the outcome from its Phase 3 program evaluating OMS103HP in patients undergoing arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. OMS103HP did not meet the pre-specified endpoints of these studies.
No conclusions could be made regarding drug effect due to confounding factors in the studies.
"Given the strength of the data from previous clinical studies of OMS103HP, we are obviously disappointed and surprised by the outcome. Our analysis of the data does not demonstrate a lack of drug effect nor does it appear to undermine the viability of our Phase 3-ready OMS103HP program for meniscectomy surgery," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "As we learn more from our data analysis, we will provide additional information on our plans for OMS103HP. In the meantime, we are continuing to advance our pipeline, including our ophthalmology program, for which we recently announced positive Phase 2b data, and our successful GPCR program."