SEATTLE, April 30, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the European Medicines Agency (EMA) has confirmed that the Company's planned Marketing Authorization Application (MAA) for its ophthalmology product OMS302 can be submitted and reviewed under the EMA's centralized procedure. OMS302, which contains mydriatic (pupil-dilating) and anti-inflammatory agents, is the Company's product being developed for use during intraocular lens replacement, including cataract surgery and refractive lens exchange. EMA's Committee for Medicinal Products for Human Use granted this eligibility for OMS302 because it represents a significant therapeutic innovation.
The EMA's centralized procedure allows submission of a single MAA that, when approved, authorizes the drug to be marketed in all European Union member states and European Free Trade Association countries rather than requiring separate national approvals. The centralized process can significantly accelerate widespread commercialization in Europe. Omeros intends to submit a New Drug Application for OMS302 to the U.S. Food and Drug Administration this quarter and an MAA to European regulators in mid-2013.
"The determination that OMS302 qualifies for centralized filing underscores the product's therapeutic innovation and allows Omeros to pursue more rapid commercialization throughout Europe," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "OMS302 promises significant benefits to ophthalmic surgeons and their patients, and we look forward to launching it in the U.S. and Europe next year."
About Omeros' OMS302 Program OMS302 is Omeros' product being developed for use during intraocular lens replacement (ILR), including cataract surgery and refractive lens exchange. OMS302 is a proprietary combination of the mydriatic (pupil dilating) agent phenylephrine and the anti-inflammatory agent ketorolac. Omeros recently completed its successful OMS302 Phase 3 clinical program and expects to submit a New Drug Application to the U.S. Food and Drug Administration this quarter and a Marketing Authorization Application to the European Medicines Agency in mid-2013.ILR involves replacement of the original lens of the eye with an artificial intraocular lens. These procedures are typically performed to replace a lens opacified by a cataract or to correct a refractive error of the lens (i.e., refractive lens exchange). OMS302 is added to standard irrigation solution used in ILR and delivered within the eye to maintain intraoperative mydriasis (pupil dilation), to prevent surgically induced miosis (pupil constriction), and to reduce postoperative pain and irritation. Maintenance of mydriasis is critical to the safety and surgical ease of the procedure. Intraoperative pupil constriction increases the risk of injury to intraocular structures and can substantially prolong surgical time.