The oral form of cetirizine is one of the most extensively used oral therapeutic for allergic rhinitis. The food and drug association (FDA) approved the first ophthalmic formulation of cetirizine (second-generation histamine-1 (H1) receptor antagonist) for use in treating ocular itching associated with allergic conjunctivitis in May 2017. This article is an update on FDA approval of ophthalmic formulation of cetirizine.
Approximately, allergic conjunctivitis is observed in 30-71% of patients with allergic rhinitis. The approval of cetirizine ophthalmic solution 0.24% was on the basis of the new drug application (NDA) which demonstrated the efficacy, safety, and tolerability of the drug in 3 phases III randomized, double-masked, vehicle-controlled clinical trials using the conjunctival antigen challenge (CAC) model. Results of the clinical trial The results reported that rapid onset…
