• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Aerie’s contract manufacturer faces regulatory hurdle

August 9, 2017 By Sarah Faulkner

AerieAerie Pharmaceuticals (NSDQ:AERI) said today that its contract manufacturer received a complete response letter from the FDA regarding a regulatory application for one of the manufacturer’s own product candidates.

The rejection letter reportedly cites a CGMP inspection at the facility as reasoning for the CRL. The facility also manufactures Aerie’s Rhopressa ophthalmic solution, which the FDA is set to approve or reject by February of next year. Aerie reported that it doesn’t think the manufacturer’s regulatory obstacle will impact the decision deadline for Rhopressa.

“Based on Aerie’s understanding of the contract manufacturer’s CAPA (Corrective and Preventative Actions) and other activities at the manufacturing site, and PDUFA dates later in 2017 for other products manufactured at that site, we currently believe it is probable that open issues will be resolved prior to the February 28, 2018 PDUFA date for Rhopressa,” the company said in prepared remarks.

The unnamed contract manufacturer reportedly told Aerie that it is working closely with the FDA to determine next steps.

In March, Aerie resubmitted a New Drug Application for the company’s Rhopressa eye drops. The initial NDA was withdrawn in October last year, after a contract manufacturer was not prepared for its pre-approval inspection.

Aerie shares held steady last week after the pharmaceutical company missed EPS estimates on Wall Street with its second quarter results.

The Irvine, Calif.-based company posted a net loss of -$28.4 million, or -82¢ per share, with its bottom line down -22.5% compared with the same period last year.

Adjusted to exclude 1-time items, earnings per share were -63¢, a penny behind consensus on The Street.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Contract Services, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Aerie Pharmaceuticals

IN CASE YOU MISSED IT

  • Medtronic enrolls first patient in study for Onyx liquid embolic system
  • BD issues voluntary recall on certain Alaris infusion pump modules
  • Sequel Med Tech expects full twiist launch in the fall
  • Insulet hires new chief HR officer from J&J
  • Breakthrough T1D, Mattel debut Barbie doll with type 1 diabetes

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS