Posted by Michael Wonder on 09 Oct 2018
Aerie Pharmaceuticals announces drug application for regulatory approval accepted for review in Europe
9 October 2018 - EMA will begin review of the marketing authorisation application for Rhokiinsa (netarsudil ophthalmic solution) 0.02%, currently marketed as Rhopressa in the United States.
Aerie Pharmaceuticals today reported that the EMA has accepted for review the marketing authorisation application for Rhokiinsa (netarsudil ophthalmic solution) 0.02%. Rhokiinsa is currently marketed as Rhopressa in the United States and is indicated for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension.
An opinion from the EMA’s Committee for Medicinal Products for Human Use on the application for Rhokiinsa is expected in the second half of 2019.
