Nicox receives FDA approval of ZERVIATE1 (cetirizine ophthalmic solution) 0.24%.
Nicox S.A., an international ophthalmic R&D company, announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ZERVIATE1 (cetirizine ophthalmic solution 0.24%; formerly AC-170) the first topical ocular formulation of this well-known antihistamine, for the treatment of ocular itching associated with allergic conjunctivitis.
“Receiving approval from the U.S. FDA for ZERVIATE is a huge milestone for Nicox and partnering discussions are underway for U.S. commercialization rights,” commented Michele Garufi, Chairman and Chief Executive Officer of Nicox. “We expect to further solidify our position as a leading ophthalmic R&D company with the anticipated FDA decision on VyzultaTM2, 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.”
Following discussion with the AMF, the Company has requested the suspension of trading in Nicox shares today, Wednesday May 31, 2017. Trading is expected to recommence shortly after the issuance of this press release
ZERVIATE CLINICAL TRIALS
The efficacy of ZERVIATE was established in three randomized, double-masked, placebo-controlled, conjunctival antigen challenge (Ora-CAC®3 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,” commented Michael Bergamini, Chief Scientific Officer and Executive Vice President of Nicox, adding “We’d like to thank the exceptional team that has worked on this project, both internally and externally.”