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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Cite this: EMA Panel Backs Netarsudil for Elevated Intraocular Pressure - Medscape - Sep 20, 2019.