Aerie Pharmaceuticals Inc. said the European Medicines Agency has accepted the application of its eye therapy Rhokiinsa for review and expects to make a decision during the second half of 2019.
The therapy is used to lower fluid pressure within the eyes of patients with open-angle glaucoma, a condition that leads to irreversible blindness, and ocular hypertension, a condition that causes high blood pressure within the eyes.
The treatment is approved in the U.S. and marketed under the Rhopressa brand name.
Durham, N.C.-based Aerie's CEO, Vicente Anido Jr., said if the drug is approved in Europe, the company will then seek approval for its other eye therapy called Roclatan.
Roclatan, which is already being reviewed in the U.S., is a fixed-dose combination of Aerie's Rhopressa with latanoprost, which is sold by Pfizer Inc. under the Xalatan brand name.