FDA Approves Allergic Conjunctivitis Treatment Zerviate

The U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Zerviate, a treatment for ocular itching associated with allergic conjunctivitis.

Zerviate (cetirizine ophthalmic solution .24%) is the first topical ocular formulation of Nicox’s antihistamine cetirizine. The new treatment underwent 3 randomized, double-masked, placebo-controlled trials to prove its efficacy prior to FDA approval.

The results of the clinical conjunctival antigen challenge trials measured the treatment’s efficacy in patients with histories of allergic conjunctivitis. In 2 of these trials, Zerviate provided less ocular itching compared to vehicle at 15-minute and 8-hour markers after treatment.

About 1-7% of patients treated with either Zerviate or vehicle in clinical trials reported adverse reactions such as hyperemia, instillation site paint, and reduction in visual acuity.

Cetirzine, the active ingredient in Zyrtec, binds competitively to histamine receptor sites to reduce swelling, itching, and vasodilation. The treatment will be recommended at a dose of one drop in each affected twice daily, approximately 8 hours apart.

Partnering discussions on federal commercialization rights are currently underway for Zerviate. Due to its NDA approval prior to December of this year, a milestone payment in Nicox shares equal to $6.8 million will be triggered.

Nicox executives lauded the “milestone approval” on Wednesday.

“Today, the approval of ZERVIATE is a testament to our team’s expertise and unwavering commitment to bringing new ophthalmic treatment options to patients,” Michael Bergamini, Chief Scientific Officer and Executive Vice President of Nicox, said. “We’d like to thank the exceptional team that has worked on this project, both internally and externally.”

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