Nicox holds successful pre-NDA meeting with FDA on AC-170 clinical package
January 26, 2015
Sophia Antipolis, France.
Nicox S.A. (NYSE Euronext Paris: COX), the international ophthalmic company, today announced that it has held a positive pre-New Drug Application (NDA) meeting with the United States Food and Drug Administration (FDA) regarding AC-170, a topical ocular formulation of cetirizine developed for the treatment of ocular itching associated with allergic conjunctivitis. The purpose of the meeting was to discuss the clinical package for AC 170, and based on the available efficacy and safety data, the Agency recommended submission of the NDA. Nicox will hold an additional pre-NDA meeting regarding the Chemistry, Manufacturing and Controls (CMC) data package, which is expected to take place in the first quarter of 2015. Nicox will update the market in due course on the expected NDA submission date.
AC-170 is a novel formulation of cetirizine being developed for the first time for topical application in the eye. Cetirizine is a second-generation histamine H1-receptor antagonist and a leading antihistamine which has been marketed for more than 25 years. AC-170 has been developed for the treatment of ocular itching associated with allergic conjunctivitis by Aciex Therapeutics, Inc., which became a wholly-owned subsidiary of Nicox in October 2014.