Nicox announced that the Food and Drug Administration (FDA) has approved Zerviate (cetirizine ophthalmic solution) 0.24% for the treatment of ocular itching associated with allergic conjunctivitis. 

Zerviate is the first topical ocular formulation of cetirizine, a second generation antihistamine. It works by binding competitively to histamine receptor sites to decrease swelling, itching, and vasodilation. Cetirizine is currently available in oral formluations for the relief of allergic symptoms.

The FDA approval was supported by data from three randomized, double-masked, placebo-controlled conjunctival antigen challenge (Ora-CAC model) clinical trials that enrolled patients with allergic conjunctivitis. Two of the trials that evaluated onset and duration showed Zerviate led to statistically and clinically significantly less ocular itching vs. vehicle at 15 minutes and 8 hours after treatment.

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Discussions regarding product launch are underway.

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