International ophthalmic company Nicox SA announced today it had submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) through its American subsidiary Nicox Ophthalmics, Inc. for approval of AC-170 — a proprietary cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis.
Additionally, the company requested a Priority Review based on clinical pediatric data associated with AC-170. If given the Priority Review, the FDA could reportedly provide a decision by the end of 2016 based on PDUFA (Prescription Drug User Fee Act) performance goals.
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