Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 330

Omeros Corporation Initiates Sales of OMIDRIA® in Europe

Posted by fidest press agency su giovedì, 26 luglio 2018

Omeros Corporation (NASDAQ: OMER) today announced initial sales of OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3% in Europe. OMIDRIA, approved and commercially available in the U.S., is also approved in the European Union (EU) for use in cataract and lens replacement surgery to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. These sales satisfy the “sunset clause” provision in the EU and maintain the ongoing validity of the European marketing authorization for OMIDRIA, allowing Omeros continued flexibility in its partnering, sales and pricing strategies for OMIDRIA throughout Europe.The “sunset clause” requires a medicinal product to be placed on the market in at least one European country within three years of the European Commission granting the product marketing authorization; otherwise, that authorization is no longer valid. Following successful completion of required testing, labeling, packaging and release for its European use, OMIDRIA has been made available on a limited basis in the EU, satisfying the clause and preserving the company’s options for European commercialization while Omeros continues building utilization and value for OMIDRIA in the U.S. Pass-through status and separate payment for OMIDRIA by the Centers for Medicare and Medicaid Services are scheduled to re-initiate in the U.S. on October 1.


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