Nicox announced that the FDA has approved the new drug application for Zerviate (cetirizine ophthalmic solution 0.24%; formerly AC-170), the first topical ocular formulation of the antihistamine cetirizine, for the treatment of ocular itching associated with allergic conjunctivitis.
"Receiving approval from the FDA for Zerviate is a huge milestone for Nicox and partnering discussions are underway for U.S. commercialization rights," Michele Garufi, Chairman and Chief Executive Officer of Nicox, said in a company news release. "We expect to further solidify our position as a leading ophthalmic R&D company with the anticipated FDA decision on Vyzulta, 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."
ZERVIATE CLINICAL TRIALS
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. 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," Michael Bergamini, Chief Scientific Officer and Executive Vice President of Nicox, said in the news release. "We'd like to thank the exceptional team that has worked on this project, both internally and externally."
Zerviate, the brand name approved by the FDA for cetirizine ophthalmic solution, 0.24% (formerly AC-170), is a novel formulation of cetirizine developed for the first time for topical application in the eye. Cetirizine, the active ingredient in Zyrtec, is a second generation antihistamine (H1 receptor antagonist) that binds competitively to histamine receptor sites to reduce swelling, itching, and vasodilation. Cetirizine, in approved oral formulations, has a well-characterized systemic efficacy and safety profile with world-wide exposure representing more than 300 million patient-years.
Approval of the Zerviate NDA on or before December 1, 2017 triggers a milestone payment in Nicox shares equivalent to $6.8 million. This payment will be made to the former shareholders of Aciex within 7 business days of the FDA approval date for Zerviate and will result in the issuance of new shares representing approximately 2.4% of the share capital.