Topical antihistamine for allergic conjunctivitis gains approval

Nicox, the French-based drugmaker, has announced FDA approval for its new topical ocular formulation of cetirizine (Zerviate) to treat ocular itching associated with allergic conjunctivitis.

The widely used second-generation antihistamine and H1 receptor antagonist binds competitively to histamine receptor sites to reduce swelling, itching and vasodilation. Nicox recommends twice daily instillation of 1 drop of cetirizine ophthalmic solution, 0.24% (formerly AC-170) approximately 8 hours apart.

The drug's efficacy was established in 3 randomized controlled trials, in which the drops significantly reduced ocular itching, both statistically and clinically, compared with placebo at 15 minutes and 8 hours after treatment.

Common adverse reactions included hyperemia, instillation site pain and reduced visual acuity, which occurred in 1% to 7% of patients.  

Discussions for U.S. commercialization rights are currently underway.