Nicox’s ZERVIATE Receives IND Approval in China

Press Release

Nicox’s ZERVIATETM Receives IND Approval in China

September 22, 2020 – release at 7:30 am 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 ZERVIATE^TM (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/2020/0922/2020092200 ...

About ZERVIATE

ZERVIATE^TM (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.