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Press Release

Nicox announces that its Exclusive Licensee Submits response to CRL for latanoprostene bunod ophthalmic solution, 0.024%

Posted on: 18 Aug 17
Press Release
Nicox announces that its Exclusive Licensee Submits response to CRL for latanoprostene bunod ophthalmic solution, 0.024%

August 18, 2017
Sophia Antipolis, France


Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today announced that its exclusive licensee has informed Nicox that it has submitted a response to the Complete Response Letter (CRL) received from the U.S. Food and Drug Administration (FDA) on August 7, 2017 concerning the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024% for the reduction of intraocular pressure in patients with glaucoma or ocular hypertension.

About latanoprostene bunod

Latanoprostene bunod is a single agent therapy eye drop with a dual mode of action. Upon instillation in the eye, latanoprostene bunod works by metabolizing into two moieties, latanoprost acid and butanediol mononitrate, each targeting a specific pathway; the first, latanoprost acid, a prostaglandin F2-alpha analog, primarily works within the uveoscleral pathway to increase aqueous humor outflow and the second, butanediol mononitrate, releases nitric oxide to increase outflow through the trabecular meshwork and Schlemm's canal.
About Nicox
Nicox S.A. is an international ophthalmic company developing innovative solutions to help maintain vision and improve ocular health. By leveraging its proprietary expertise in nitric oxide donation and other technologies, the Company is developing an extensive portfolio of novel drug candidates that target multiple ophthalmic conditions, including glaucoma. Nicox currently has one product, through its exclusive licensee, at the review stage with the U.S. Food and Drug Administration (FDA), latanoprostene bunod ophthalmic solution, 0.024%, and one product with an approved NDA, ZERVIATE (cetirizine ophthalmic solution) 0.24%. In addition our promising drug-candidate pipeline includes a next-generation of stand-alone nitric-oxide donors and exploratory novel NO-donating compounds, as well as repurposing of existing molecules with the potential to offer novel approaches to treat a range of ophthalmic conditions. Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker symbol: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes.

For more information on Nicox, its products or pipeline, please visit:
Analyst coverage
Bryan, Garnier & Co   Hugo Solvet   Paris, France
Invest Securities   Martial Descoutures   Paris, France
Gilbert Dupont   Damien Choplain   Paris, France


The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.


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The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.

Risks factors which are likely to have a material effect on Nicox's business are presented in the 4th chapter of the 'Document de référence, rapport financier annuel et rapport de gestion 2016' filed with the French Autorité des Marchés Financiers (AMF) on March 29, 2017, and in the updated and additional risk factors as of August 14, 2017, which are available on Nicox's website (
Nicox S.A.
Drakkar 2
Bât D, 2405 route des Dolines
CS 10313, Sophia Antipolis
06560 Valbonne, France
T +33 (0)4 97 24 53 00
F +33 (0)4 97 24 53 99


Last updated on: 21/08/2017

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