Aerie Pharmaceuticals announced the European Commission (EC) has granted a marketing authorization for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% for 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 marketing authorization application (MAA) for Roclanda was accepted for review by the European Medicines Agency (EMA) in January 2020. Aerie received a positive scientific opinion recommending approval of the Roclanda MAA from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in November 2020.
“The receipt of the EC marketing authorization for Roclanda, which is the only fixed-dose combination IOP-lowering therapy with a prostaglandin analogue that does not include a beta blocker, is an important regulatory milestone for Aerie on the heels of the recently reported successful interim topline data from our Mercury 3 clinical trial which demonstrated efficacy that was noninferior to Ganfort,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release. “We are preparing for pricing discussions in Germany while continuing our evaluation of collaboration opportunities for Europe, and the receipt of this marketing authorization represents an important step in furthering all of those discussions.”
Roclanda was approved by the FDA in March 2019 under the trade name Rocklatan for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. Rhokiinsa was granted a marketing authorization by the EC in November 2019 for the reduction of elevated IOP in adult patients with primary open-angle glaucoma or ocular hypertension. Rhokiinsa was approved by the FDA in December 2017 under the trade name Rhopressa for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension.
The marketing authorization is valid in all 27 countries of the European Union, plus Iceland, Norway and Liechtenstein. As the EC decision was received after the end of the Brexit transition period, Aerie will complete a further administrative step in order to obtain a license in the United Kingdom. No reexamination of clinical data by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is expected.