08 August 2017
Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, has been informed by its partner Bausch + Lomb (a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.) of the receipt of a Complete Response Letter from the U.S. FDA concerning latanoprostene bunod ophthalmic solution, 0.024% which resulted in the attached press release issued by Valeant yesterday. The text of this press release is copied below.
VALEANT PHARMACEUTICALS RECEIVES COMPLETE RESPONSE LETTER FROM THE FDA FOR LATANOPROSTENE BUNOD OPHTHALMIC SOLUTION, 0.024% NDA
LAVAL, QUEBEC, Aug. 7, 2017 – Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an investigative intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.
The CRL from the FDA only refers to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb’s manufacturing facility in Tampa, Fla. The FDA did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.
Valeant will work closely with the FDA to determine the appropriate next steps for the NDA.