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Nicox receives FDA approval of Zerviate for ocular itching
The FDA has approved the new drug application for Zerviate to treat ocular itching associated with allergic conjunctivitis, according to a Nicox press release.
Zerviate is the first topical ocular formulation of the antihistamine cetirizine.
“Receiving approval from the U.S. FDA for Zerviate is a huge milestone for Nicox, and partnering discussions are underway for U.S. commercialization rights,” Michele Garufi, Nicox chairman and CEO, said in the release.
The drug’s efficacy was previously studied in three randomized, double-masked, placebo-controlled, conjunctival antigen challenge clinical trials, in which it was shown to demonstrate less ocular itching compared with vehicle.
Perspective
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Allergic disease is a common condition that clinicians both inside and outside of ophthalmology encounter with regularity. Patients often suffer from redness, itching and watery eyes. Zerviate is a new formulation of cetirizine (cetirizine ophthalmic solution 0.24%) and is the first topical ocular formulation of this second-generation antihistamine. It was recently approved by the FDA and is a welcome addition to the portfolio of drugs available to treat ocular allergy. The approval was supported by data from three randomized controlled trials, including placebo-controlled conjunctival antigen challenge.
Allergic conjunctivitis can be persistent and frustrating for patients and clinicians alike. Having a new option to treat this condition will add positively to how we approach and manage the disease.