A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 0.24% Ophthalmic Solution Used Twice Daily in Healthy Adult Subjects and in Pediatric Subjects With a History or Family History of Atopic Disease (Including Allergic Conjunctivitis)
Phase of Trial: Phase III
Latest Information Update: 28 Jul 2017
At a glance
- Drugs Cetirizine (Primary)
- Indications Allergic conjunctivitis
- Focus Adverse reactions; Registrational
- Sponsors Aciex Therapeutics
- 11 Apr 2017 According to Nicox media release, A Prescription Drug User Fee Act (PDUFA) date of September 8, 2017 was assigned by the US FDA for its decision on the revised NDA for ZERVIATE(cetirizine ophthalmic solution) for the treatment of ocular itching associated with allergic conjunctivitis, and revised NDA was submitted on March 8, 2017.
- 21 Jun 2016 According to Nicox media release, the U.S. 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 October 18, 2016.
- 19 Apr 2016 According to a Nicox media release, the company has submitted an NDA for AC-170 (cetirizine eye drop formulation) for the treatment of ocular itching associated with allergic conjunctivitis. The company also requested a Priority Review, which, if obtained, could result in an FDA decision by the end of 2016 based on Prescription Drug User Fee Act (PDUFA) performance goals.