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, 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.
CORXEL acquired the Greater China rights for Varenicline nasal spray in August 2021 from Oyster Point Pharma. In February 2023, Varenicline solution nasal spray was approved in Macao SAR, and since April 2023, it has been available in Boao Lecheng International Medical Tourism Pilot Zone as an imported drug for patients with urgent clinical needs. In July 2023, the new drug application was formally accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the PRC. In November 2024, NMPA Approved the New Drug Application for Varenicline Solution Nasal Spray.
Reference:
- Song P, Xia W, Wang M, et al. Variations of dry eye disease prevalence by age, sex, and geographic characteristics in China: a systematic review and meta-analysis. Journal of global health (2018); 8(2):020503.
- Liu, Ning-ning, et al. Prevalence of and Risk Factors for Dry Eye Symptom in Mainland China: A Systematic Review and Meta-Analysis. Journal of Ophthalmology (2014); 2014(3):748654–8.
- Jie Y, Xu L, Wu YY, Jonas JB. Prevalence of dry eye among adult Chinese in the Beijing Eye Study. Eye (Lond) (2009); 23(3):688-93.
- Liu, Sun, Zhang, et al (2020). "Consensus of Chinese dry eye experts: Definition and Classification." Chin J Ophthalmol 56(6):418-422
- Liu, Sun, Zhang, et al (2020). "Consensus of Chinese dry eye experts: treatment." Chin J Ophthalmol 56(12):907-913
