Omeros Corp. 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 United States.
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 United States 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.
“Omidria is an important advance in cataract and lens replacement surgery,” stated Richard Lindstrom, adjunct clinical professor emeritus at the University of Minnesota’s Department of Ophthalmology and past president of both the American Society of Cataract and Refractive Surgeons and the International Society of Refractive Surgery. “Miosis and postoperative pain are frequent and largely unpredictable, and their occurrence can make the procedure more difficult for the surgeon and unpleasant postoperatively for the patient. While not changing their surgical routine, the use of Omidria will better allow ophthalmic surgeons to control the operative experience and, I expect, will improve surgical outcomes.”
In pivotal trials in which all patients received standard pupil-dilating and anesthetic agents prior to surgery, Omidria demonstrated statistically significant and clinically meaningful improvement in the prevention of miosis and reduction of postoperative pain relative to placebo. Ocular adverse reactions in the trials were similar between the Omidria and placebo groups and included eye irritation, posterior capsule opacification, increased intraocular pressure and anterior chamber inflammation.
“The approval and near-term market launch of Omidria could not come at a better time,” stated Eric Donnenfeld, clinical professor of ophthalmology at New York University and immediate-past president of the American Society of Cataract and Refractive Surgery. “With increasingly restrictive regulations around compounding, surgeons are looking for a safe and effective FDA-approved product to improve surgical outcomes by maintaining pupil dilation during lens replacement surgery and that quickly resolves postoperatively, potentially allowing faster recovery of vision. In addition, the anti-inflammatory ketorolac in Omidria could reduce the need for preoperative NSAIDs.”
With FDA approval of Omidria, Omeros is completing preparations for a late summer/early fall 2014 U.S. product launch.
“The FDA approval of Omidria is the first of what we expect will be a long line of product approvals for Omeros given our deep pipeline of products, many of which are currently in clinical trials,” stated Gregory Demopulos, chairman and chief executive officer of Omeros. “We have continued to round out our commercialization team and are focused on obtaining European approval for Omidria, securing Medicare pass-through reimbursement and successfully launching the product in the United States later this year. In parallel, our premier clinical and non-clinical programs are advancing, and we look forward to sales of Omidria significantly defraying future development costs of our rich pipeline.”
Date: June 2, 2014