EMA Panel Backs Netarsudil for Elevated Intraocular Pressure

Troy Brown, RN

September 20, 2019

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for netarsudil ophthalmic solution 0.02% (Rhokiinsa; Aerie Pharmaceuticals) for the treatment of adults with glaucoma or ocular hypertension.

The full indication is "reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension."

Netarsudil is a Rho kinase inhibitor that increases outflow of aqueous humor via the trabecular outflow pathway and reduces episcleral venous pressure.

Netarsudil ophthalmic solution 0.02% will be sold as an eyedrop solution containing 200 µ/mL.

"We are delighted that the CHMP has adopted a positive opinion for Rhokiinsa," Vicente Anido Jr, PhD, chairman and chief executive officer at Aerie, said in a company news release.

Netarsudil ophthalmic solution 0.02% was approved by the US Food and Drug Administration December 18, 2017, and is currently marketed as Rhopressa in the United States.

The company said it expects a decision from the European Commission in approximately 2 months; that decision will apply to all European Union member states plus Iceland, Liechtenstein, and Norway.

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