Aerie Pharmaceuticals announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of the marketing authorization application (MAA) for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%. The recommended indication is the reduction of elevated IOP in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction.
The CHMP positive opinion is a scientific recommendation for marketing authorization, which is referred to the European Commission for a final decision on the company’s MAA. The final decision is expected in approximately 2 months and will be applicable to all European Union member states plus Iceland, Norway, and Liechtenstein.
“We are delighted that the CHMP has adopted a positive opinion for Roclanda,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release. “We look forward to the European Commission’s final decision on the MAA for Roclanda, which is expected by early next year.”
Roclanda is currently marketed as Rocklatan in the United States and is indicated for the reduction of elevated IOP in patients with open-angle glaucoma or hypertension.