The Food and Drug Administration (FDA) has completed its initial 60–day review of the New Drug Application (NDA) for Rhopressa (netarsudil; Aerie) 0.02% and determined that it’s sufficiently complete to permit a substantive review.
The NDA submission was supported by data from two Phase 3 registration trials for Rhopressa, Rocket 1 and Rocket 2. Additionally, results from Mercury 1, the initial Phase 3 registration trial for Aerie’s combination product Roclatan (netarsudil/latanoprost ophthalmic solution), was also included in the application as supportive data.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of February 28, 2018 to complete the review and make a decision on the NDA. The agency has also notified the company that no review issues were identified and that it’s currently planning to hold an advisory committee.
Rhopressa is a novel, once daily, ophthalmic solution designed to lower intraocular pressure 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.