CHMP recommends Rhokiinsa for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.- Aerie Pharmaceuticals. </p>
Aerie Pharmaceuticals, Inc. 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.
Comment: 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.