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Thursday, January 2, 2020

Roclanda marketing authorization application accepted in Europe - Healio

The European Medicines Agency has accepted and will review the marketing authorization application for Roclanda, Aerie Pharmaceuticals announced in a press release.

Roclanda (netarsudil and latanoprost ophthalmic solution 0.02%/0.005%), marketed as Rocklatan in the Unites States, is indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension.

“We are delighted that the European regulatory authorities have accepted our Roclanda filing for review. If approved, Roclanda, the combination of our Rho kinase inhibitor with a prostaglandin analog, would be the first fixed-dose combination of its kind in Europe,” Vicente Anido Jr., PhD, chairman and CEO at Aerie, said in the release.

An opinion on the application is expected later this year.

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Roclanda marketing authorization application accepted in Europe - Healio
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