FDA Clears Cetirizine Eye Drops for Allergic Conjunctivitis

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The US Meals and Drug Administration (FDA) has permitted the primary topical ocular formulation of the antihistamine cetirizine for the therapy of ocular itching related to allergic conjunctivitis.

The efficacy of cetirizine ophthalmic answer 0.24% (Zerviate, Nicox SA) was demonstrated in three randomized, double-masked, placebo-controlled, conjunctival antigen problem medical trials in sufferers with a historical past of allergic conjunctivitis, in response to an organization information launch.

In two of those trials evaluating onset and period of impact, Zerviate demonstrated statistically and clinically considerably much less ocular itching in contrast with automobile at quarter-hour and eight hours after therapy, the corporate mentioned.

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

“Cetirizine, in permitted oral formulations, has a well-characterized systemic efficacy and security profile with world-wide publicity representing greater than 300 million patient-years,” the corporate notes.

The really useful dose of Zerviate is one drop in every affected eye twice every day, roughly 8 hours aside.

Probably the most generally reported antagonistic reactions are ocular hyperemia, instillation web site ache, and discount in visible acuity, which occurred in roughly 1% to 7% of sufferers handled with Zerviate or automobile in medical trials.

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