Omeros Corporation has reported unsuccessful results from the Phase III programme evaluating OMS103HP in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery.
OMS103HP did not meet the pre-specified endpoints of these studies, and no conclusions were made regarding drug effects due to confounding factors.
Omeros chairman and CEO Gregory Demopulos said that the analysis of the data did not demonstrate a lack of drug effect or undermine the viability of the Phase III-ready OMS103HP programme for meniscectomy surgery.
OMS103HP is a proprietary combination of ketoprofen, amytriptyline and oxymetazoline, which is injected into standard arthroscopic irrigation solutions and perfused through the joint in low concentrations during surgery.
It is intended for use during arthroscopic surgery to improve post-operative joint motion and function and reduce post-operative pain.