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FDA approves Omidria for intraocular lens replacement surgery
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Omeros Corp. announced that the U.S. Food and Drug Administration has approved the use of phenylephrine and ketorolac injection during cataract and IOL replacement surgeries, according to a press release.
Phenylephrine and ketorolac injection 1% / 0.3% (Omidria, Omeros Corp.) is a combination of an anti-inflammatory agent and a mydriatic agent; it is the only FDA-approved product designed to prevent intraoperative miosis and reduce postoperative pain, according to the release.
In phase 3 clinical trials, the product demonstrated statistically significant efficacy compared with placebo for the prevention of miosis and reduction of postoperative pain, according to the press release.
Eric B. Donnenfeld
The approval does not require any additional post-marketing studies, except for the previously agreed upon study of the drug’s use in pediatric patients, according to the release. If successfully completed, the drug would be eligible for an additional 6 months of U.S. marketing exclusivity.
“The approval and near-term market launch of Omidria could not come at a better time,” Eric B. Donnenfeld, MD, Ocular Surgery News Cornea/External Disease Editorial Board Member, said in the press release. “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.”
The product is expected to launch in late summer or early fall.
Perspective
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Richard L. Lindstrom, MD
The approval of Omidria from Omeros gives us our first FDA-approved intracameral drug to enhance the safety and comfort of cataract surgery. Most of us put epinephrine in the balanced salt solution bottle during cataract surgery to help maintain pupillary dilation, but this is a very off-label use. Every year, this type off-label drug usage becomes riskier from a safety and regulatory perspective. Omidria gives us the combined benefit of phenylephrine and ketorolac for intraoperative use during cataract surgery. The data from two prospective, randomized trials show reduced intraoperative miosis and intraoperative pain as a meaningful benefit. It will be nice to have this FDA-approved alternative to the off-label epinephrine available. Market penetration will depend on pricing and third-party reimbursement, or lack thereof. I am very interested in accessing this new product for my patients.
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