Image: Nicox
Paris-listed international ophthalmic company Nicox, on Friday said that its exclusive licensee has said 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.
Nicox, headquartered in Sophia Antipolis, France, 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%.
Nixon, which is a part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes, has a drug-candidate pipeline that 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.
About Latanoprostene
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.