Aerie Pharmaceuticals announced that the European Medicines Agency (EMA) has accepted for review the marketing authorization application (MAA) for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%. Roclanda is currently marketed as Rocklatan in the United States, where it is indicated for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. An opinion from the EMA’s Committee for Medicinal Products for Human Use on the MAA for Roclanda is expected in late 2020.
“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 Chief Executive Officer at Aerie, said in a company news release. “As EMA review continues of the Roclanda MAA, we expect to complete and analyze our Mercury 3 study in the second half of 2020. The Mercury 3 study, which compares Roclanda to the leading fixed-dose combination product in Europe, is not a requirement for EMA approval, but rather is designed to support pricing and reimbursement activities in Europe.”