OMS103 is our PharmacoSurgery® product candidate designed for use during arthroscopic partial meniscectomy surgery. OMS103 is added to standard arthroscopic irrigation solutions and perfused through the joint during surgery. Each active ingredient in OMS103 was selected for its anti-inflammatory action, and each agent interacts with discrete molecular targets involved in the acute inflammatory response.
In 2010 we completed a successful Phase 2 trial in patients undergoing partial meniscectomy surgery that demonstrated statistically significant clinical benefits in functional recovery, range of motion and pain reduction. In 2012, we completed a multicenter, double-blind, Phase 3 clinical trial evaluating OMS103 in patients undergoing arthroscopic partial meniscectomy surgery. The pre-specified primary endpoint was the Symptoms Subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). In addition, pain measured in the early postoperative period was a pre-specified secondary endpoint. Although the Symptoms Subscale of the KOOS did not reach statistical significance, OMS103 achieved statistically significant (p=0.0003) reduction of postoperative pain compared to placebo. The pain reduction data were similar in magnitude to those in an earlier Phase 2 clinical trial. OMS103 also demonstrated improvement across a series of pain-related assessments and was well tolerated in this study.
OMS103 is encompassed by our PharmacoSurgery patent portfolio. The relevant patents and patent applications in this portfolio are directed to combinations of agents, generic and/or proprietary to us or to others, drawn from therapeutic classes such as pain and inflammation inhibitory agents and vasoconstrictive agents, delivered locally and intraoperatively to the site of medical or surgical procedures, including arthroscopy. As of February 16, 2018, we owned three issued U.S. patents and three pending U.S. patent applications, together with 36 issued patents and eight pending patent applications in foreign markets, that are directed to OMS103.