SOPHIA ANTIPOLIS, France—Nicox S.A. (Euronext Paris: FR0013018124, COX), an ophthalmic research and discovery company, has announced that the Food and Drug Administration (FDA) has approved its new drug Zerviate (cetirizine ophthalmic solution 0.24%), the first topical ocular formulation of this antihistamine. The new drug is approved as a treatment for ocular itching associated with allergic conjunctivitis.

Cetirizine is the active ingredient in the allergy treatment Zyrtec.

“Receiving approval from the FDA for Zerviate is a huge milestone for Nicox and partnering discussions are under way for U.S. commercialization rights,” Michele Garufi, chairman and chief executive officer, said in a statement. “We expect to further solidify our position as a leading ophthalmic R&D company with the anticipated FDA decision on Vyzulta (a potential treatment for glaucoma), which is licensed worldwide to Bausch + Lomb, and the expected commencement of Phase 2 clinical trials for both NCX 4251 and NCX 470. This is an exciting time for Nicox, and we look forward to keeping you updated on our progress.”

The efficacy of Zerviate was established in three randomized, double-masked, placebo-controlled, conjunctival antigen challenge (Ora-CAC model of allergic conjunctivitis) clinical trials in patients with a history of allergic conjunctivitis, according to the Nicox announcement. Onset and duration were evaluated in two of these trials in which Zerviate demonstrated statistically and clinically significantly less ocular itching compared to vehicle at 15 minutes and 8 hours after treatment.

“Today, the approval of Zerviate is a testament to our team’s expertise and unwavering commitment to bringing new ophthalmic treatment options to patients,” chief scientific officer and executive vice president Michael Bergamini added. “We'd like to thank the exceptional team that has worked on this project, both internally and externally.”