Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today 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."
About Zerviate
Zerviate, the brand name approved by the U.S. 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®4, 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-years5,6,7.
Approval of the Zerviate NDA on or before 1st December 2017 triggers a milestone payment in Nicox shares equivalent to $6.8 million8. 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.
Important Information about Zerviate
INDICATION: Zerviate (cetirizine ophthalmic solution) 0.24% is indicated for treatment of ocular itching associated with allergic conjunctivitis.
DOSAGE AND ADMINISTRATION: The recommended dose is one drop in each affected eye twice daily (approximately 8 hours apart).
IMPORTANT SAFETY INFORMATION
The most commonly reported adverse reactions occurred in approximately 1-7% of patients treated with either Zerviate or vehicle. These reactions were ocular hyperemia, instillation site pain, and reduction in visual acuity.
About Allergic Conjunctivitis
Allergic conjunctivitis occurs when an allergic reaction causes conjunctivitis. Conjunctivitis is an inflammation of the thin layer of tissue that lines the white surface of the eye and the inner surface of the eyelids. It is a common eye disease, especially in children, and may affect one or both eyes. The signs and symptoms may include eye redness, excessive watering, itchy burning eyes, discharge, blurred vision and increased sensitivity to light. It is estimated that more than 75 million people suffer from allergic conjunctivitis in the U.S.9 and the prevalence ranges from 20% to 40%...
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