Aerie Pharmaceuticals announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of the marketing authorization application (MAA) for Rhokiinsa (netarsudilophthalmic solution) 0.02%. The recommended indication is the reduction of elevated IOP 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 approximately 2 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,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release. “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 IOP in patients with open-angle glaucoma or ocular hypertension.