EU approves Omidria (phenylephrine and ketorolac injection) for use in cataract surgery- Omeros Corp

Omeros Corporation announced that the European Commission has granted marketing authorization for Omidria (phenylephrine 1% and ketorolac 0.3% injection) in the European Union for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. This approval allows for the marketing of Omidria in all EU member states plus Iceland, Liechtenstein, and Norway.

Approval in the EU is based on the same clinical data that were the basis for the US approval received from the FDA last year and follows the previously reported unanimous positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use. Decisions about price and reimbursement for Omidria occur on a country-by-country basis.