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Nicox receives FDA approval of Zerviate for ocular itching

Issue: July 2017

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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.