Nicox announced that the FDA has accepted the company's new drug application 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 October 18, 2016. Such date is indicative and contingent upon the information (including data) to be eventually provided by Nicox in the review period, according to a company news release.
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.
AC-170 is a novel formulation of cetirizine, the active ingredient in Zyrtec 1, which has been developed for the first time 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 stabilizer that binds competitively to histamine receptor sites to reduce swelling, itching and vasodilation. Cetirizine, as an approved oral drug, has a well-characterized systemic safety and efficacy profile with worldwide exposure representing more than 300 million patient-years2-3-4. AC-170 is covered by two granted U.S. patents expiring in 2030 and 2032.
Approval of the AC-170 NDA prior to 1st December 2016 will trigger a milestone payment of $35 million in Nicox shares to ex-Aciex shareholders or $10 million in Nicox shares if approval of the NDA is received after this date. AC-170 was developed by Aciex Therapeutics, Inc., which became a wholly-owned subsidiary of Nicox in October 2014 and was subsequently renamed Nicox Ophthalmics, Inc.