Nicox receives FDA approval of Zerviate (cetirizine ophthalmic solution) 0.24%

Nicox

31 May 2017 - U.S. patent protection until at least 2030.

Nicox today announced that the U.S. FDA has approved the new drug application for Zeviate (cetirizine ophthalmic solution 0.24%; formerly AC-170) the first topical ocular formulation of this well-known anti-histamine, for the treatment of ocular itching associated with allergic conjunctivitis.

The efficacy of Zerviate was established in three randomised, double-masked, placebo-controlled, conjunctival antigen challenge (Ora-CAC 3 model of allergic conjunctivitis) clinical trials in patients with a history of allergic conjunctivitis. Onset and duration were evaluated in two of these trials in which Zerviate demonstrated statistically and clinically significantly less ocular itching compared to vehicle at 15 minutes and 8 hours after treatment.

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Michael Wonder

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Michael Wonder

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Outcome , US , Submission