The US Food and Drug Administration (FDA) has approved phenylephrine and ketorolac injection (Omidria, Omeros Corporation) 1%/3% for use during cataract surgery or intraocular lens replacement (ILR), according to a company statement.
The drug prevents intraoperative miosis (pupil constriction) and reduces postoperative pain.
Omidria is a proprietary combination of a pupil-dilating agent (phenylephrine) and an anti-inflammatory agent (ketorolac) that is added to the standard irrigating solution used during cataract surgery and other ILR procedures, including refractive lens exchange. Collectively, these surgical procedures are the most common surgical procedures performed in the United States (almost 4 million annually).
The drug is the only such product approved by the FDA.
"Omidria is an important advance in cataract and lens replacement surgery," Richard L. Lindstrom, MD, adjunct clinical professor emeritus at the University of Minnesota's Department of Ophthalmology in Minneapolis and past president of both the American Society of Cataract and Refractive Surgeons and the International Society of Refractive Surgery, said in the company statement. "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."
The decision follows a review of data from pivotal trials in which all patients were given standard pupil-dilating and anesthetic agents before surgery. Patients who received the drug experienced statistically significant and clinically meaningful improvement in miosis prevention and postoperative pain reduction relative to placebo.
Ocular adverse reactions in the studies occurred at 2% to 24% and were similar between the treatment groups and the placebo groups; they included eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation. Systemic exposure of phenylephrine may cause elevated blood pressure. The drug must be diluted before use and is not approved for use in children.
"The approval and near-term market launch of Omidria could not come at a better time," Eric B. Donnenfeld, MD, clinical professor of ophthalmology at New York University, Rockville Center, New York, and immediate-past president of the American Society of Cataract and Refractive Surgery said in the company statement. "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 [nonsteroidal anti-inflammatory drugs]."
The company has no postmarketing requirements except for those in place for studies among pediatric patients, which, if successfully completed, mean that the drug will be eligible for an additional 6 months of marketing exclusivity in the United States.
Omeros expects to launch the drug in the United States in late summer/early fall 2014.
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Cite this: FDA Approves Omidria for Cataract Surgery, Lens Replacement - Medscape - Jun 02, 2014.