BioCentury
ARTICLE | Clinical News

Valeant gets second CRL for Vyzulta

August 11, 2017 4:08 PM UTC

Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) said FDA issued a second complete response letter for Vyzulta latanoprostene bunod to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Valeant said the CRL cites CGMP inspection issues at the company's Bausch + Lomb manufacturing facility in Tampa, Fla., and did not identify any safety or efficacy concerns. Valeant said it will work closely with FDA on next steps. The first CRL was issued in July 2016 (see BioCentury, Aug. 1, 2016).

In 2014, Nicox S.A. (Euronext:COX) exercised its option to co-promote the nitric oxide (NO)-donating prostaglandin F2-alpha analog in the U.S. under a 2010 deal granting Bausch + Lomb exclusive, worldwide rights to develop and commercialize the product. Valeant acquired Bausch + Lomb in 2013 (see BioCentury, March 8, 2010 & Sept. 8, 2014)...