Omeros receives EMA CHMP positive opinion for Omidria for cataract, IOL replacement surgery

May 22 2015

Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for both large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, today announced that the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Omidria^® (phenylephrine and ketorolac injection) 1%/0.3%. Omidria is used during cataract surgery and other intraocular lens (IOL) replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and reduce postoperative eye pain. Cataract surgery and IOL 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.

The positive opinion adopted for Omidria by CHMP was supported unanimously by committee members and represents an intermediate step toward patient access to Omidria in Europe. No post-marketing follow-up studies or measures were recommended by CHMP for Omidria. Next, the CHMP opinion will be reviewed by the European Commission (EC), and the decision by the EC on approval of Omidria will be applicable to all European Union member states plus Iceland, Lichtenstein, and Norway. The EC decision is due approximately two months following CHMP's opinion. Decisions about price and reimbursement for Omidria occur on a country-by-country basis.

Omidria was approved by the U.S. Food and Drug Administration in 2014 and last month was made broadly available nationwide for commercial use. The company has received strongly positive feedback from ophthalmic surgeons, the product being used in cataract and IOL replacement surgery both with and without femtosecond laser and in routine as well as complicated cases, including those with intraoperative floppy iris syndrome (IFIS) and pseudoexfoliation, a common cause of glaucoma. Reimbursement for Omidria has been confirmed across each of the U.S. Medicare Administrative Contractor regions.

"We are pleased that CHMP unanimously endorsed the benefits of Omidria for both ophthalmic surgeons and their patients in Europe," stated 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."