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Aerie Pharmaceuticals gets recommendation for Rhokiinsa in the European Union

European Commission will in about two months decide on the Committee for Medicinal Products for Human Use’s positive opinion, recommending approval of Rhokiinsa in EU, developed by Aerie Pharmaceuticals, for reduction of elevated intraocular pressure  in adult patients.

DURHAM, N.C.–(BUSINESS WIRE)–Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of the marketing authorisation application (MAA) for Rhokiinsa® (netarsudil ophthalmic solution) 0.02%. The recommended indication is the reduction of elevated intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension.

The CHMP positive opinion is a scientific recommendation for marketing authorisation referred to the European Commission for a final decision on the Company’s MAA. The final decision is expected in approximately two months and will be applicable to all European Union member states plus Iceland, Norway and Liechtenstein.

“We are delighted that the CHMP has adopted a positive opinion for Rhokiinsa®,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “We look forward to the European Commission’s final decision on the MAA for Rhokiinsa® and, if approved, we plan to submit the MAA for Roclanda®, marketed as Rocklatan® in the United States, shortly thereafter.”

Rhokiinsa® is currently marketed as Rhopressa® in the United States and is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

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