European Commission grants marketing authorization for Omeros’ Omidria

This approval allows for the marketing of Omidria in all EU member states plus Iceland, Lichtenstein, and Norway. Cataract surgery and lens replacement are among the most common surgical procedures worldwide, with approximately 3.9 million of them expected to be performed in Western Europe alone in 2015.

"European ophthalmic surgeons are excited by the approval of Omidria in the EU," said Roberto Bellucci, MD, professor of ophthalmology at the University of Verona, Italy, director of the Ophthalmic Unit at the Hospital of Verona, and current president of the European Society for Cataract and Refractive Surgeons.

"For the first time, we will have a product that provides consistent and predictable management of intraoperative miosis – a problem that can be challenging for surgeons. I expect that use of Omidria will translate into better outcomes for our patients and, together with the drug’s ability to reduce postoperative pain, will improve patient satisfaction following cataract surgery."

Approval in the EU is based on the same clinical data that were the basis for the U.S. approval received from the U.S. Food and Drug Administration 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.

"We are pleased with the European Commission’s decision to allow commercialization of Omidria throughout the EU and other European countries," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros.

"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."

Omeros’ PharmacoSurgery product Omidria contains the mydriatic (pupil-dilating) agent phenylephrine and the anti-inflammatory agent ketorolac and was developed for use during cataract or other IOL replacement surgery. The FDA has approved Omidria for use during cataract surgery or IOL replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain.