European Commission approves Rhokiinsa marketing authorization
A marketing authorization for Rhokiinsa, for the reduction of elevated IOP in open-angle glaucoma or ocular hypertension, has been approved by the European Commission, according to a press release.
Known as Rhopressa in the United States, Rhokiinsa (netarsudil ophthalmic solution 0.02%, Aerie Pharmaceuticals) was accepted for review by the European Medicines Agency in October 2018 and received a positive scientific opinion recommending approval from the EMA’s Committee for Medicinal Products for Human Use earlier this year.
“Importantly, this approval also sets the stage for our filing of an MAA for Roclanda (netarsudil 0.02% and latanoprost 0.005% ophthalmic solution) with the EMA by early 2020, and we would expect that review process would take approximately 1 year. In the interim, we look forward to our Rocklatan, known as Roclanda in Europe, Mercury 3 data expected by mid-2020. These data will help set the stage for our commercialization strategy in Europe,” Vicente Anido Jr., PhD, Aerie chairman and CEO, said in the release.
The Rhokiinsa authorization is valid in all European Union countries, as well as Iceland, Norway and Liechtenstein.