BioCentury
ARTICLE | Clinical News

Aerie's Roclatan under FDA review with March PDUFA

July 27, 2018 6:18 PM UTC

Aerie Pharmaceuticals Inc. (NASDAQ:AERI) said FDA accepted for review an NDA for Roclatan netarsudil/latanoprost to reduce intraocular pressure (IOP) in glaucoma or ocular hypertension. The PDUFA date is March 14, 2019.

Roclatan met its primary endpoint of reducing IOP vs. either of its two components in the two Phase III Mercury 1 and Mercury 2 trials for the indications...