Nov. 20, 2013
/PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today reported that the U.S. Food and Drug Administration (FDA) accepted the proposed brand name Omidria™ for OMS302, the Company's proprietary product in development for use in intraoperative lens replacement (ILR) surgery. FDA's acceptance of the proprietary brand name is subject to the Agency's final determination prior to any approval of the product's New Drug Application (NDA) and market launch, expected in 2014. Omeros earlier received allowance of the trademark application for Omidria from the U.S. Patent and Trademark Office.
The FDA reviews proposed proprietary names, taking into account potential for confusion between the proposed name and the names of marketed drugs and pending products for which marketing applications are currently under review. The brand name Omidria was also submitted to the European Medicines Agency (EMA), with a decision anticipated later this year. Omeros recently registered Omidria as a European Community Trade Mark.
"Throughout branding analyses conducted with ophthalmic surgeons and nurses using both regulatory and marketing criteria, Omidria scored very high globally – across the US,
as well as in
Gregory A. Demopulos
, M.D., chairman and chief executive officer of Omeros. "With FDA's acceptance, we can now accelerate the development of the Omidria brand in preparation for the product's anticipated market launch in 2014."
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' NDA for OMS302 has been accepted for filing by the FDA and its MAA for OMS302 has been validated by the EMA.