Cyclosporine Eye Drops 0.09% for the Treatment of Dry Eye Disease Obtains Clinical Trial Notice
2020-06-30 21:56

Reference is made to the announcement of China Medical System Holdings Limited dated 27 June 2019 (the ¡°Previous Announcement¡±) related to signing a License Agreement of Cyclosporine A, 0.09% eye drops (the name in the clinical trial notice currently obtained issued by the National Medical Products Administration of the People¡¯s Republic of China is ¡°Cyclosporine Eye Drops 0.09%¡±) (the ¡°Product¡±) for the treatment of dry eye disease with Sun Pharmaceutical Industries Ltd.. The Product is a nanotechnology enabled-formulation in a clear, preservative-free, aqueous solution, and has been approved by the U.S. Food and Drug Administration under CEQUATM brand name for commercialisation in the USA. 

The Company is pleased to announce that the Product has been granted a clinical trial notice issued by the National Medical Products Administration of the People¡¯s Republic of China on 30 June 2020 and agreed to carry out a clinical trial regarding increasing tear secretion in patients with keratoconjunctivitis sicca, namely a randomized, double-blind, placebo-controlled, multi-center clinical study on the safety and effectiveness of Cyclosporine Eye Drops 0.09% for the treatment of keratoconjunctivitis sicca. The Group is currently actively preparing for initiating the clinical trial of the Product.