Nicox files NDA at FDA for AC 170 (proprietary cetirizine eye drop formulation) for conjunctivitis

Nicox announced the submission of a New Drug Application (NDA) to the FDA for approval of AC 170, its novel proprietary cetirizine eye drop formulation, for the treatment of ocular itching associated with allergic conjunctivitis.

Based on clinical paediatric data generated with AC 170, the Company also requested a Priority Review, which, if obtained, could result in an FDA decision by the end of 2016 based on PDUFA (Prescription Drug User Fee Act) performance goals.

Nicox is seeking regulatory approval for AC 170 using the FDA’s Section 505(b)(2) regulatory pathway, which enables the Company to rely, in part, on the FDA’s prior findings of safety and efficacy for cetirizine and on the published literature in support of the NDA.