A

glaucoma drug developed by Aerie Pharmaceuticals (AERI) is currently under review by FDA regulators at the agency’s Rockville, Md., campus, but the decision to approve or reject more likely hinges on the rehabilitation of a dysfunctional manufacturing facility located 900 miles to the south in Tampa, Fla.

Time and circumstances don’t work in Aerie’s favor. The manufacturing facility where Aerie’s drug Rhopressa is made is owned by Bausch & Lomb, a unit of troubled specialty pharmaceuticals firm Valeant Pharmaceuticals (VRX). The plant has a long history of FDA quality control violations Bausch & Lomb can’t seem to fix.

This is a STAT Plus article and you can unlock it by subscribing to STAT Plus today. It's easy! Your first 30 days are free and if you don't enjoy your subscription you can cancel any time.
Already a subscriber? Log in here.

Leave a Comment

Please enter your name.
Please enter a comment.

Sign up for our Morning Rounds newsletter

Your daily dose of news in health and medicine.