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# Nicox Submits NDA for Ocular Itching
- URL: https://www.fdaweb.com/nicox-submits-nda-for-ocular-itching/
- Published: 2016-04-20T12:00:00.000Z
- Updated: 2026-09-14T20:56:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135444

Nicox SA has submitted through its American subsidiary Nicox Ophthalmics, Inc., an NDA to FDA seeking approval of AC-170, its cetirizine eye drop formulation, for treating ocular itching associated with allergic conjunctivitis. The company says it is also seeking priority review based on clinical pediatric data generated with AC-170\. Nicox adds that the formulation of cetirizine, which is the active ingredient in Zyrtec, has been developed for the first time for topical application. Two Phase 3 safety and efficacy trials demonstrated statistically significant results for AC-170 compared to vehicle control (placebo) for the primary endpoint of ocular itching, according to the company.