Nicox’s ZERVIATE Receives IND Approval in China
September 22, 2020
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its partner, Ocumension Therapeutics, has received approval from China’s Center for Drug Evaluation of the National Medical Products Administration to carry out Phase 3 clinical trials on ZERVIATETM (cetirizine ophthalmic solution), 0.24% for the treatment of ocular itching associated with allergic conjunctivitis. ZERVIATE, the first topical ocular form of cetirizine, is licensed exclusively to Ocumension Therapeutics in the Chinese and in the majority of South East Asian markets. The Phase 3 trial is expected to start in Q4 2020.
Dr. José Boyer, Vice President and Head, Clinical Development at Nicox, said: “The submission of the IND in China was the result of an effective collaboration between the development teams at Ocumension and Nicox. This approval allows Ocumension to accelerate the Phase 3 program for the approval of ZERVIATE in China, and we look forward to continuing to support them in the next steps of bringing ZERVIATE to commercialisation there.”
The Press Release by Ocumension can be found here: https://www1.hkexnews.hk/listedco/listconews/sehk/2020/0922/2020092200013.pdf
ZERVIATETM (cetirizine ophthalmic solution), 0.24% is a novel formulation of cetirizine developed and approved for the first time for topical application in the eye for the treatment of ocular itching associated with allergic conjunctivitis. Cetirizine, the active ingredient in ZYRTEC®, is a second-generation antihistamine (H1 receptor antagonist) that binds competitively to histamine receptor sites. Cetirizine, in approved oral formulations, has a well-characterized systemic efficacy and safety profile with worldwide exposure resulting from 20 years of oral use. ZERVIATE was developed by Nicox as the first and only formulation of cetirizine for topical application in the eye.
ZERVIATE was launched in the United States in March 2020 by Eyevance Pharmaceuticals, Nicox’s exclusive U.S. licensee, and is also licensed exclusively to Samil Pharmaceutical in South Korea and to ITROM Pharmaceutical Group in the Gulf and Arab markets.
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 outside of the white surface of the eye and the inner surface of the eyelids. It 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