Sze Yuan Yang, General Manager of TSH Biopharm, announced today (7/11) that TSH is entering into the field of ophthalmology. According to research findings, approximately 3 million people in Taiwan are suffering from dry eye disease. Recognizing this target market, TSH's inaugural ophthalmology product is Tyrvaya® nasal spray, a new drug developed by Oyster Point Pharma in the United States for the treatment of dry eye disease. TSH receives the commercialization support of Tyrvaya® in Taiwan from JIXING Pharmaceuticals and TSH will initiate registration of Tyrvaya®.

Dry eye disease is a multifactorial ocular surface disease characterized by a damaged tear film, requiring continuous treatment and care. The natural tear film in humans, containing growth factors and antibacterial components, can protect and moisturize the eyes, wash away foreign substances, and form a smooth surface that serves as the primary refractive surface of the eye. The current treatment options cannot fully meet the needs of patients. Therefore, TSH has introduced Tyrvaya®, the world's first nasal spray for the treatment of dry eye disease. Through this new route of administration, Tyrvaya® enhances the secretion of natural tear film, making it suitable for patients with mild to severe dry eye disease and providing a more convenient and safe medication option to patients.

According to data from two clinical trials involving a total of 940 patients with dry eye disease, patients experienced an increase in tear production on average after just one dose. The symptoms and signs of dry eye were significantly improved during the 2-week period of Tyrvaya® use. Furthermore, after 4 weeks of use, the average amount of natural tear film produced was still significantly increased. The use of Tyrvaya® nasal spray to enhance the secretion of natural tear film brings better treatment response and experience for patients with dry eye disease.

Tyrvaya® nasal spray obtained FDA approval as a new drug in 2021 and was launched in the United States. TSH and JIXING officially start collaboration and initiate the registration and commercialization preparation for Tyrvaya® in Taiwan. “We are very pleased to build strategic partnership with TSH, and believe that TSH's industry experience and commercialization capabilities will provide strong support for the commercialization of Tyrvaya® nasal spray in Taiwan in the future.” said Sandy Mou, Chief Executive Officer of JIXING. “We will work closely with TSH to make this product a new treatment option for dry eye patients.”

About Tyrvaya nasal spray
Tyrvaya nasal spray is a highly selective cholinergic agonist that is U.S. FDA approved to treat the signs and symptoms of dry eye disease as a multidose nasal spray. The parasympathetic nervous system, the "rest and digest" system of the body, controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose. The efficacy of Tyrvaya nasal spray in dry eye disease is believed to be the result of varenicline's activity at heteromeric sub-type(s) of the nicotinic acetylcholine (nACh) receptor where its binding produces agonist activity and activates the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Varenicline binds with high affinity and selectivity at human α4β2, α4α6β2, α3β4, α3α5β4 and α7 neuronal nicotinic acetylcholine receptors. The exact mechanism of action is unknown at this time.

About TSH Biopharm
TSH Biopharm starts in the field of chronic diseases and adheres to the principles of integrity and honesty. With a focus on innovation and excellence, our mission is to provide superior healthcare services for all stages of patient care. Our core products are centered around "patient-centric" treatments, including cardiovascular medications, gastrointestinal medications, and central nervous system medications. We cultivate the niche market of chronic diseases while simultaneously pursuing a dual-engine strategy to pioneer precision medicine and offer comprehensive treatment options. For more information, please visit www.tshbiopharm.com.

About JIXING 
JIXING is a biopharmaceutical company headquartered in Shanghai committed to bringing innovative science and medicines to underserved patients in China with serious and life-threatening diseases. Backed by RTW Investments, LP, JIXING was founded in 2019 and partners with global biotechnology companies to develop and commercialize novel, innovative therapeutics to treat unmet medical needs in cardiovascular and ophthalmic diseases. With a strong and further developing asset pipeline, seasoned management team, and patient-centric focus, JIXING is dedicated to delivering a meaningful and lasting impact on patients in China.

References: 

• Wirta, D., Vollmer, P., Paauw, J., et al.& ONSET-2 Study Group. Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease: the ONSET-2 Phase 3, Randomized Trial. Ophthalmology 2021; -:1-9. https: //doi.org/10.1016/j.ophtha.2021.11.004.
• Wirta, D., Torkildsen, G. L., Boehmer, B., Hollander, D. A., Bendert, E., Zeng, L., ... & Nau, J. (2022). ONSET-1 phase 2b randomized trial to evaluate the safety and efficacy of OC-01 (varenicline solution) nasal spray on signs and symptoms of dry eye disease. Cornea.
• Market-Scope. 2020 Dry Eye Products Report: A Global Market Analysis for 2019 to 2025. October 2020.
• Uchino M., Schaumberg D.A. Dry Eye Disease: Impact on Quality of Life and Vision. Curr. Ophthalmol. Rep. 2013; 1:51–57. doi: 10.1007/s40135-013-0009-1.
• Tsubota K, Pflugfelder S, Liu Z, et al. Defining dry eye from a clinical perspective. Int J Mol Sci 2020; 21 (23):9271. doi: 10.3390/ijms21239271.
• 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. doi: 10.7189/jogh.08.020503.