Tuesday, August 5, 2014

Topic: FDA Approves Omidria for Use in Cataract and Other Intraocular Lens Replacement Procedures

FDA Approves Omidria for Use in Cataract and Other Intraocular Lens Replacement Procedures
Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Food and Drug Administration (FDA) has approved Omidria (phenylephrine and ketorolac injection) 1%/0.3% for use during cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative pain. The approval comes with no post-marketing commitments other than the previously agreed study of Omidria for use in pediatric patients, which, if successfully completed, makes the drug eligible for an additional six months of marketing exclusivity in the U.S.Omidria, the first commercial product from Omeros' PharmacoSurgery® platform, is a proprietary combination of a mydriatic (pupil-dilating) agent and an anti-inflammatory agent that is added to irrigation solution standardly used during cataract surgery and other ILR procedures (e.g., refractive lens exchange), collectively the most common surgical procedures performed in the U.S. at nearly four million annually. Omidria is the only FDA-approved product for intraocular use that prevents intraoperative miosis and reduces postoperative pain, providing consistent and predictable management of both of these ILR-related problems for ophthalmic surgeons and their patients. To read more, please click on this link: http://www.chronicintractablepainandyou.net/apps/forums/topics/show/12978624-fda-approves-omidria-for-use-in-cataract-and-other-intraocular-lens-replacement-procedures