The European Union drug regulators have recommendded the approval of Omeros Corporation’s Omidria, aphenilephrine and ketorolac injection. The drug is designed to improve clinical outcomes of patients undergoing ophthalmological procedures.
Omidria is used during cataract surgery and other intraocular lens (IOL) replacement procedures to maintain intraoperative mydriasis (pupil dilation), prevent miosis (pupil constriction) and reduce postoperative eye pain. Cataract surgery and IOL replacement are two of the most common surgical procedures worldwide.
The decision made by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) received the unanimous support of the committee members and embodies an intermediate step towards patient access to Omidria in the EU. The recommendation is now being sent to the European Commission for final approval.
Omidria has already been approved by the US Food and Drug Administration (FDA) one year ago. Last month, Omidria was even available for commercial uses nationwide. The Seattle-based company has received strongly positive feedback from ophthalmic surgeons.
According to Gregory A. Demopulos, chairman and chief executive officer of Omeros, “We are pleased that CHMP unanimously endorsed the benefits of Omidria for both ophthalmic surgeons and their patients in Europe. Omeros controls the worldwide rights to Omidria, and our independent product launch in the US is progressing nicely. For Omidria in Europe, we plan to partner for marketing and distribution, and we look forward to the European Commission’s decision in July“.