FDA assigns Prescription Drug User Fee Act (PDUFA) goal date of 18 October 2016
Nicox, the international ophthalmic company, has announced that the US Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for AC-170, a novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis.
The FDA also granted Priority Review and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of 18 October 2016. The date is indicative and contingent upon the information (including data) to be provided by Nicox in the review period.
The October PDUFA date means Nicox now has decisions expected from the FDA on two of its compounds, AC-170 and latanoprostene bunod, by the end of 2016.
About AC-170: AC-170 is a novel formulation of cetirizine, the active ingredient in Zyrtec, which has been developed for topical application in the eye for the treatment of ocular itching associated with allergic conjunctivitis. Cetirizine is a second generation antihistamine and mast cell stabiliser that binds competitively to histamine receptor sites to reduce swelling, itching and vasodilation.
About allergic conjunctivitis: Allergic conjunctivitis occurs when an allergic reaction causes conjunctivitis. Conjunctivitis is an inflammation of the thin layer of tissue that lines the white surface of the eye and the inner surface of the eyelids.
It is estimated that more than 75 million people suffer from allergic conjunctivitis in the US and the prevalence ranges from 20% to 40%. The annual US market for the treatment of allergic conjunctivitis totals more than $800m.