European Commission grants marketing authorization for Roclanda
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The European Commission has granted marketing authorization for Roclanda to reduce IOP in adults with primary open-angle glaucoma or ocular hypertension, according to a press release from Aerie Pharmaceuticals.
Roclanda (netarsudil 0.02% and latanoprost 0.005% ophthalmic solution) is authorized for patients who have insufficient IOP reduction with prostaglandin or netarsudil monotherapy, the release said.
“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 non-inferior to Ganfort,” Vicente Anido Jr., PhD, chairman and CEO of Aerie, said in the release.
The authorization is valid in all 27 EU countries, as well as Iceland, Norway and Liechtenstein. In order to receive a license in the United Kingdom, Aerie will complete further administrative steps, although no reexamination of clinical data is expected, the release said.
The drug was approved in the United States in March 2019 under the name Rocklatan.
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