EU Regulators Approve Omidria for Lens Replacement Surgery


May 22, 2015

European Union (EU) drug regulators have recommended approval of phenylephrine and ketorolac injection (Omidria, Omeros) for lens replacement eye surgery.

Phenylephrine maintains intraoperative mydriasis, or pupil enlargement, and prevents intraoperative miosis, or pupil constriction. Ketorolac is a nonsteroidal anti-inflammatory drug that relieves acute postoperative pain. The two ingredients are added to a standard irrigating solution.

Yesterday's decision by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) comes roughly 1 year after the US Food and Drug Administration approved phenylephrine and ketorolac injection for the same indication.

Eye pain and anterior chamber inflammation are the most common adverse events associated with the drug, according to an EMA news release.

The recommendation now goes to the European Commission, the executive branch of the EU, for final approval.

More information is available on the EMA website.


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