Dry eye disease (DED)
Dry eye disease (DED) is a multifactorial disorder of the ocular surface resulting in visual impairment, eye pain, poor corneal wound healing, and tear film instability.
Normal tear film is fundamental to eye health and serves a multitude of functions that include providing a smooth corneal surface for clear vision, the ability of the eye to respond to changing environmental conditions, and suppression of inflammation and infection.
It is estimated that over 200 million people in China are impacted by DED, significantly influencing a person’s day-to-day quality of life. Despite the large prevalence and a significant disease burden, there remains large unmet need in DED as current therapies only target distinct components of the dry eye cycle, such as inflammation instead of re-establishing a healthy tear film.
Varenicline nasal spray, approved in the U.S. with the brand name of Tyrvaya, and OC-02 (simpinicline) nasal sprays contain nicotinic agonists, that bind to specific receptors in the nasal mucosa to elicit production of natural tears. Delivering Tyrvaya and OC-02 directly to the target tissue via a nasal spray is an innovative approach to the treatment of DED. The nasal spray delivery platform can provide both preservative free and preserved product formulations.
Our partner, Oyster Point Pharma, announced NDA approval of OC-01 Nasal Spray for the treatment of the signs and symptoms of dry eye disease in October 2021. OC-02 has been previously studied by Oyster Point Pharma in two Phase 2b clinical trials for dry eye disease. As part of the dry eye disease clinical development pathway in China, JIXING will initiate Phase 3 clinical study for OC-01 in 2H 2022 and Phase 1 and Phase 3 for OC-02 in 1H 2024.
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