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Aerie Pharmaceuticals' Roclanda eye drops accepted for EU review

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Aerie Pharmaceuticals' Roclanda eye drops accepted for EU review

Aerie Pharmaceuticals Inc. said the European Medicines Agency accepted Roclanda's application for review.

The Durham, N.C.-based pharmaceutical company is seeking marketing approval for the eye drops to treat patients with ocular hypertension, or elevated pressure in the eye, who are at an increased risk of developing glaucoma, a disease that can lead to vision loss and blindness.

The EMA's Committee for Medicinal Products for Human Use is expected to give its decision on the medicine in late 2020, Aerie Pharmaceuticals said in a Jan. 2 press release.

Roclanda is marketed in the U.S. as Rocklatan. Aerie is studying the drug in a phase 3 trial called Mercury 3 and expects to complete the study in the second half of 2020.

The trial is not a requirement for the EU application but has been undertaken to support pricing and reimbursement activities in the EU, Aerie Pharmaceuticals said.