Advertisement Omeros' Omidria gets EMA committee positive opinion for cataract and IOL procedures - Pharmaceutical Business review
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Omeros’ Omidria gets EMA committee positive opinion for cataract and IOL procedures

US-based biopharmaceutical firm Omeros has received positive opinion from the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) for Omidria (phenylephrine and ketorolac injection) 1%/0.3%, for use during cataract surgery and other intraocular lens (IOL) replacement procedures.

Omidria helps to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction) as well as to reduce postoperative eye pain.

The company’s PharmacoSurgery product Omidria, which contains the mydriatic (pupil-dilating) agent phenylephrine and the anti-inflammatory agent ketorolac, was developed for use during cataract or other IOL replacement surgery.

Cataract surgery and IOL replacement are among the most common surgical procedures worldwide and this year about 3.9 million of them are expected to be performed in Western Europe alone.

Omeros chairman and chief executive officer Gregory Demopulos said: "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."

The US Food and Drug Administration approved Omidria in 2014 and it was made available nationwide for commercial use last month.

Omeros is focused on 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 (CNS).