Aerie Pharmaceuticals Receives Marketing Authorization of Roclanda in Great Britain

Aerie Pharmaceuticals announced that Roclanda 50 micrograms/ml + 200 micrograms/ml eye drops solution (latanoprost + netarsudil) has received marketing authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain. Roclanda is indicated 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 (reference Great Britain Summary of Product Characteristics).

Roclanda was granted a marketing authorization by the European Commission (EC) in January 2021 for the same indication. The EC marketing authorization is valid in all 27 countries of the European Union, plus Iceland, Norway and Liechtenstein. Through the EC marketing authorization, Roclanda is also authorized in Northern Ireland. As the EC decision was received after the end of the Brexit transition period, Aerie was required to complete a further administrative step in order to obtain authorization in Great Britain, which has now been granted.

“The authorization of Roclanda in Great Britain, the only fixed-dose combination IOP-lowering therapy with a prostaglandin analogue that does not include a beta blocker, is another important regulatory milestone for Aerie on the heels of the receipt of the EC marketing authorization for Roclanda in January,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in company news release. “We continue to evaluate our potential collaboration opportunities in Europe and this authorization is another important step in furthering those discussions.”

Roclanda was authorized 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.