18 August 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 F2α 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.