The FDA has approved Omeros’ phenylephrine and kertorolac injection 1%/0.3% (Omidria) for use during cataract surgery or IOL replacement (ILR) to maintain pupil size by preventing intraoperative miosis and to reduce postoperative pain.
Seattle-The FDA has approved Omeros’ phenylephrine and kertorolac injection 1%/0.3% (Omidria) for use during cataract surgery or IOL replacement (ILR) to maintain pupil size by preventing intraoperative miosis and to reduce postoperative pain.
The approval comes with no post-marketing commitments other than the previously agreed study of the drug for use in pediatric patients, which, if successfully completed, makes the drug eligible for an additional 6 months of marketing exclusively in the United States.
"The FDA approval of (the drug) 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," said Gregory A. Demopulos, MD, chairman and chief executive officer of Omeros. "We have continued to round out our commercialization team and are focused on obtaining European approval for (the drug), securing Medicare pass-through reimbursement and successfully launching the product in the United States later this year.”
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The drug is a proprietary combination of a mydriatic agent and an anti-inflammatory agent that is added to irrigation solution standardly used during cataract surgery and other ILR procedures.
In pivotal trials-in which all patients received standard pupil-dilating and anesthetic agents prior to surgery-the drug 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 drug and placebo groups, and included eye irritation, posterior capsule opacification, increased IOP, and anterior chamber inflammation.
With the drug’s approval, Omeros is completing preparations for a late summer or early fall 2014 U.S. product launch.
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