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Omeros receives marketing authorization for Omidria in European Union

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The European Commission has granted marketing authorization for Omidria for use in cataract surgery and lens replacement procedures in the European Union, Omeros announced in a press release.

The approval allows for the marketing of Omidria (phenylephrine 1% and ketorolac 0.3%) in all EU member states and also Iceland, Lichtenstein and Norway.

“We have developed strong thought-leader support across Europe, and building on the growing success of Omidria in the U.S., we expect the product to be well received by European cataract surgeons,” Gregory A. Demopulos, MD, chairman and CEO of Omeros, said in the release.

The approval is based on the same clinical data as the U.S. approval by the FDA and follows a previously reported positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use, the release said.

Pricing and reimbursement for Omidria will be decided by individual countries.