Omeros Corporation announced that the European Medicines Agency (EMA) has confirmed that OMS103HP is eligible to be submitted for marketing approval in the European Union (EU) through the EMA centralized procedure. OMS103HP is Omeros' lead product candidate currently in a phase III clinical programme evaluating the drug's safety and ability to improve postoperative joint function and reduce pain following Anterior Cruciate Ligament (ACL) reconstruction surgery. Omeros continues to expect the release of phase III results this quarter.

For eligible drugs, the centralized procedure permits the submission of a single marketing application to the EMA that, if approved, allows the drug to be marketed in all EU member states, as well as Iceland and Norway, rather than requiring independent national approvals. OMS103HP qualified for the centralized procedure as a significant therapeutic innovation and because it provides a new alternative to patients in preventing disease. National procedures can take more than two years to grant marketing approval, and the centralized procedure can reduce that time to commercialization in the relevant countries by as much as 12 months.

“We are pleased that EMA views OMS103HP as worthy of centralized review, potentially accelerating our drug's European market launch,” stated Gregory A. Demopulos, MD, chairman and chief executive officer of Omeros. “We are working towards database lock and look forward to unblinding and analyzing the data later this quarter.”

OMS103HP is being developed for use during arthroscopic surgery to reduce postoperative pain and improve postoperative joint motion and function. OMS103HP is injected into standard arthroscopic irrigation solutions and perfused through the joint in low concentrations during surgery. It is currently being evaluated in a phase III clinical programme for Anterior Cruciate Ligament (ACL) surgery and has also completed a phase II clinical trial for meniscectomy surgery. If approved, OMS103HP would be the first commercially available drug delivered directly to the surgical site to improve function following arthroscopic surgery.

Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system and its clinically advanced product candidates are derived from its proprietary PharmacoSurgery platform designed to improve clinical outcomes of patients undergoing a wide range of surgical and medical procedures.