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Ocumension Therapeutics
歐康維視生物
(Incorporated in the Cayman Islands with limited liability)
(Stock Code:1477)
VOLUNTARY ANNOUNCEMENT
PHASE III CLINICAL TRIAL OF OT-1001 (ZERVIATE)
APPROVED IN CHINA
The board (the "Board") of directors of Ocumension Therapeutics (together with its subsidiaries, the "Group") is pleased to announce that one of the Group's pipeline, OT-1001 (ZERVIATE),
- potent and highly selective histamine-1 receptor antagonist with anti-allergic properties, has recently been approved by the Center for Drug Evaluation of the National Medical Products Administration of the People's Republic of China to carry out its phase III clinical trial in China, for the treatment of ocular itching associated with allergic conjunctivitis.
Studies have shown that OT-1001 (ZERVIATE) has better effectiveness and safety compared to existing anti-allergic therapeutic agents. OT-1001 (ZERVIATE) has a rapid onset of action, and the effect is able to last for at least 8 hours after administration. OT-1001 (ZERVIATE) covers a wider range of patients. In addition to treating adult patients, it is the only opthalmic antihistamine approved by the United States Food and Drug Administration for treating pediatric patients of two years and older, which is able to meet the current clinical needs of treating pediatric patients with allergic conjunctivitis.
The approval of OT-1001 (ZERVIATE) for phase III clinical trial in China indicates that the late-stage clinical and commercialized product pipeline of the Group has been further enriched. The Group will actively advance the phase III clinical trial of OT-1001 (ZERVIATE), and strive to commercialize the product as soon as possible, with the aim of bringing a new solution for the clinical treatment of allergic conjunctivitis.
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INFORMATION ON OT-1001 (ZERVIATE)
ZERVIATE was developed by Nicox Ophthalmics, Inc. (together with its subsidiaries and affiliates, "Nicox"). It is the first and only topical ophthalmic formulation of antihistamine cetirizine approved by the United States Food and Drug Administration to treat ocular itching associated with allergic conjunctivitis. The Group obtained an exclusive license from Nicox to develop, make, have made, import, export, use, distribute, market, promote, offer for sale and sell (or otherwise commercialize) ZERVIATE in the Greater China region in March 2019, and extended the exclusive rights to 11 countries in Southeast Asia in March 2020.
By order of the Board of
Ocumension Therapeutics
Dr. Lian Yong CHEN
Chairman and Executive Director
Shanghai, the People's Republic of China, September 22, 2020
As of the date of this announcement, the Board comprises Dr. Lian Yong CHEN, Mr. Ye LIU, Dr. Zhaopeng HU and Dr. Wei LI as executive Directors, Mr. Yanling CAO and Mr. Lefei SUN as non-executive Directors, and Mr. Ting Yuk Anthony WU, Mr. Lianming HE, and Mr. Yiran HUANG as independent non-executive Directors.
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