FDA approves cetirizine ophthalmic solution 0.24%

FDA has approved the New Drug Application for cetirizine ophthalmic solution 0.24% (Zerviate—Nicox SA) for the treatment of ocular itching associated with allergic conjunctivitis.

FDA has approved the New Drug Application for cetirizine ophthalmic solution 0.24% (Zerviate—Nicox SA) for the treatment of ocular itching associated with allergic conjunctivitis. The efficacy of cetirizine ophthalmic solution 0.24% was demonstrated in three randomized, double-masked, placebo-controlled conjunctival antigen challenge clinical trials in patients with a history of allergic conjunctivitis. In two of the trials evaluating onset and duration, cetirizine ophthalmic solution 0.24% demonstrated statistically and clinically significantly less ocular itching compared with vehicle at 15 minutes and 8 hours after treatment. The recommended dose is one drop in each affected eye twice daily (about 8 hours apart). The most commonly reported adverse events were ocular hyperemia, instillation site pain, and reduction in visual acuity, according to Nicox.