Omeros has reported unsuccessful results from the Phase 3 programme evaluating OMS103HP in patients undergoing arthroscopic anterior cruciate ligament (ACL) reconstruction surgery.
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OMS103HP did not meet the pre-specified endpoints of these studies.
No conclusions were made regarding the drug-effect due to confounding factors in the studies.
Omeros chairman and chief executive officer Gregory Demopulos said the analysis of the data does not demonstrate a lack of drug effect nor does it appear to undermine the viability of the Phase 3-ready OMS103HP programme for meniscectomy surgery.
OMS103HP is a proprietary combination of ketoprofen, amytriptyline, and oxymetazoline that is injected into standard arthroscopic irrigation solutions and perfused through the joint in low concentrations during surgery.
OMS103HP is intended for use during arthroscopic surgery to improve postoperative joint motion and function and reduce postoperative pain.
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