On Jun. 2, 2014, Omeros announced that the U.S. Food and Drug Administration (FDA) had 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 was 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.

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.

With FDA approval of Omidria, Omeros was completing preparations for a late summer/early fall 2014 U.S. product launch.