Aerie Pharmaceuticals announced that it has submitted the marketing authorization application (MAA) for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% with the European Medicines Agency (EMA). Should the MAA for Roclanda be accepted for review by the EMA, an opinion from the Committee for Medicinal Products for Human Use is expected in approximately 12 months. Roclanda is currently marketed in the United States as Rocklatan.
The MAA submission for Roclanda was predicated on the receipt of a marketing authoriation for Rhokiinsa (netarsudil ophthalmic solution) 0.02%, which the European Commission granted last week. Rhokiinsa is marketed as Rhopressa in the United States.
“Our regulatory team and other internal support groups worked tirelessly to complete the Roclanda MAA filing so quickly after the receipt of the Rhokiinsa marketing authorization,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release. “In Europe, fixed-dose combinations with prostaglandins are frequently prescribed for the reduction of intraocular pressure associated with glaucoma. If approved, the combination of our Rho kinase inhibitor with a prostaglandin would be a first for Europe, and we look forward to working with the EMA in the coming months with the goal of bringing this potential new treatment to patients. As EMA review of the Roclanda MAA begins, we will be completing and analyzing our Mercury 3 study, which compares Roclanda to the leading fixed-dose combination product in the European Union. We expect results from this study will be reported next year, which should support our pricing and reimbursement activities.”