The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Aerie Pharmaceuticals’ (NASDAQ:AERI) marketing authorization application (MAA) for Rhokiinsa solution.
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 authorization referred to the European Commission for a final decision on the company’s MAA. The final decision is expected in about two months and will be applicable to all European Union member states plus Iceland, Norway and Liechtenstein.
“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 U.S., shortly thereafter,” Vicente Anido, Jr., chairman and CEO of Aerie, said in a statement.
Rhokiinsa is currently marketed as Rhopressa in the U.S. and is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.