FDA Clears Cetirizine Eye Drops for Allergic Conjunctivitis
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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.
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@nimmy 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.