FDA Clears Cetirizine Eye Drops for Allergic Conjunctivitis

Megan Brooks


June 01, 2017

The US Food and Drug Administration (FDA) has approved the first topical ocular formulation of the antihistamine cetirizine for the treatment of ocular itching associated with allergic conjunctivitis.

The efficacy of cetirizine ophthalmic solution 0.24% (Zerviate, Nicox SA) was demonstrated in three randomized, double-masked, placebo-controlled, conjunctival antigen challenge clinical trials in patients with a history of allergic conjunctivitis, according to a company news release.

In two of these trials evaluating onset and duration of effect, Zerviate demonstrated statistically and clinically significantly less ocular itching compared with vehicle at 15 minutes and 8 hours after treatment, the company said.

Cetirizine is a second-generation antihistamine (H1 receptor antagonist) that binds competitively to histamine receptor sites to reduce swelling, itching, and vasodilation.

"Cetirizine, in approved oral formulations, has a well-characterized systemic efficacy and safety profile with world-wide exposure representing more than 300 million patient-years," the company notes.

The recommended dose of Zerviate is one drop in each affected eye twice daily, approximately 8 hours apart.

The most commonly reported adverse reactions are ocular hyperemia, instillation site pain, and reduction in visual acuity, which occurred in roughly 1% to 7% of patients treated with Zerviate or vehicle in clinical trials.

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