Nicox S.A. has reported the U.S. FDA has approved the New Drug Application (NDA) for ZERVIATE (cetirizine ophthalmic solution 0.24%; formerly AC-170) -- reportedly the first topical ocular formulation of this well-known antihistamine, for the treatment of ocular itching associated with allergic conjunctivitis.
ZERVIATE is reportedly a novel formulation of cetirizine developed for the first time for topical application in the eye. The efficacy of ZERVIATE was reportedly established in three randomized, double-masked, placebo-controlled, conjunctival antigen challenge clinical trials in patients with a history of allergic conjunctivitis.
According to Nicox, partnering discussions are now underway for U.S. commercialization rights for ZERVIATE.
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