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"cataract", "European Medicine Agency", "Omeros Corporation", "Omidria®"

European Medicines Agency Committee Gives Positive Opinion On Omidria

European Medicines Agency Committee Gives Positive Opinion On Omidria

Omeros Corporation a company focused on discovering, developing and commercializing small-molecule and protein therapeutics, recently announced that the EMA (European Medicines Agency) Committee for Medicinal Products for Human Use (CHMP) provided a favourable opinion on the company’s drug candidate Omidria (phenylephrine and ketorolac injection) 1%/0.3%.

Omidria contains the mydriatic (pupil-dilating) agent phenylephrine together with the anti-inflammatory agent ketorolac and was developed for use during cataract or other IOL replacement surgery to preserve mydriasis (pupil dilation), reduce eye pain following surgery and prevent miosis (pupil constriction).

CHMP’s favourable outlook on Omidria represents a step ahead on the development and commercialization of the product in Europe. The CMHP considered that no more studies assessing the product are needed, however the European Commission (EC) will now review CHMP’s opinion for the commercialization of the product in the European Union, Norway, Iceland and Lichtenstein. This decision should be made within the next two months and each country has the right to establish the prices and reimbursement for Omidria. The drug received the approval from the FDA in 2014 and is now commercialized in the US.

Ophthalmic surgeons have given a positive feedback about the product, which is being used in cataract and IOL replacement surgery with as well as without femtosecond laser. Omidria is used both in routine and complicated cases such as in those patients with pseudoexfoliation and intraoperative floppy iris syndrome (IFIS), a well known cause of glaucoma. The U.S. Medicare Administrative Contractor regions confirmed the reimbursement for the product.

“We are pleased that CHMP unanimously endorsed the benefits of Omidria for both ophthalmic surgeons and their patients in Europe,” stated in a recent press release Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “Omeros controls the worldwide rights to Omidria, and our independent product launch in the U.S. 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.”

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