NDA for Novel Glaucoma, Ocular Hypertension Drug Submitted to FDA
Aerie announced the submission of its New Drug Application (NDA) to the Food and Drug Administration (FDA) for Rhopressa (netarsudil ophthalmic solution) 0.02% to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.
The NDA submission was supported by data from Rocket 1 and Rocket 2, two Phase 3 registration trials for Rhopressa in patients with glaucoma or ocular hypertension. The company is also investigating Rhopressa in a fixed dose combination with latanoprost (Roclatan), with two Phase 3 trials, Mercury 1 and Mercury 2, currently underway.
Rhopressa is a novel, once daily, ophthalmic solution designed to lower IOP via three different mechanisms. It increases fluid outflow through the trabecular meshwork by inhibiting Rho Kinase (ROCK), reduces fluid production in the eye by inhibiting norepinephrine transporter (NET), and lowers episcleral venous pressure.
For more information visit Aeriepharma.com.