A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of AC-170 0.24% Ophthalmic Solution (Formula AFH-002) Compared to Vehicle (Formula AFH-001) in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
Phase of Trial: Phase III
Latest Information Update: 31 May 2017
At a glance
- Drugs Cetirizine (Primary)
- Indications Allergic conjunctivitis
- Focus Registrational; Therapeutic Use
- Sponsors Aciex Therapeutics
- 31 May 2017 According to a Nicox media release, the US FDA has approved the New Drug Application (NDA) for ZERVIATE1 (cetirizine ophthalmic solution 0.24%; formerly AC-170) for the treatment of ocular itching associated with allergic conjunctivitis. The approval was based on this and two other trials using the conjunctival antigen challenge (Ora-CAC model of allergic conjunctivitis).
- 19 Apr 2016 Primary endpoint (Ocular itching at defined time points up to 2 weeks) has been met, according to a Nicox media release.
- 22 Oct 2015 According to a Nicox media release, the company expects to submit a New Drug Application for cetirizine [AC-170] by the first half of 2016.