TSH (TW-8432) had a successful performance in 2023, and there is another good news today. At the beginning of 2024, Taiwan's Food and Drug Administration (TFDA) has accepted the New Drug Application (NDA) for the TYRVAYA® Nasal Spray, after TSH announced in July 2023 to initiate registration and provide commercialization support for TYRVAYA® Dry Eye Disease Nasal Spray in Taiwan. If the review process proceeds smoothly, approval is expected by the end of 2024.

General Manager Sze Yuan Yang stated that TYRVAYA® is a new drug developed by the American pharmaceutical company Oyster Point Pharma to address dry eye disease. The drug received FDA approval and was successfully launched in the United States in 2021. TSH receives the commercialization support of Tyrvaya® in Taiwan from JIXING Pharmaceuticals and TSH will initiate registration of Tyrvaya®.

Dry eye is an ocular condition caused by various factors, characterized by damage to the tear film. A healthy tear film protects and lubricates the eyes, flushing away foreign particles. However, the current therapeutic drugs in Taiwan have not fully met the needs of patients. TSH Ophthalmology's new drug, TYRVAYA® Nasal Spray, is a highly selective cholinergic receptor agonist. Approved by the U.S. FDA as a preservative-free nasal spray in multi-dose packaging, it is designed to treat the signs and symptoms of dry eye syndrome. It promotes the natural secretion of tears in patients, making it suitable for individuals with mild to severe dry eye disease and providing a more convenient and safe treatment option.

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, bringing better treatment response and experience for patients with dry eye disease.

General Manager Sze Yuan Yang pointed out that the dry eye disease market is huge and growing rapidly. According to Global Data's "Dry Eye Syndrome: Global Drug Forecast and Market Analysis to 2028", the compound annual growth rate of dry eye disease from 2018 to 2028 is as high as 10.6%, and it is estimated that the global market value will reach the highest $11.1 billion by 2028. Taking into account this continuous growth trend, TSH is actively expanding the ophthalmology market, hoping to accelerate future business capabilities and meet the challenges of market potential.

About TYRVAYA® Nasal Spray
TYRVAYA® nasal spray (Varenicline solution nasal spray) is a highly selective cholinergic agonist that is U.S. FDA approved to treat signs and symptoms of dry eye disease as a multidose nasal spray. The parasympathetic nervous system controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose. The efficacy of varenicline solution 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.
 

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.
 

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.

• GlobalData. 2020 Dry Eye Syndrome – Global Drug Forecast and Market Analysis to 2028. May 30, 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.

• Kuo, Y. K., Lin, I. C., Chien, L. N., Lin, T. Y., How, Y. T., Chen, K. H., Dusting, G. J., & Tseng, C. L. (2019). Dry Eye Disease: A Review of Epidemiology in Taiwan, and its Clinical Treatment and Merits. Journal of clinical medicine, 8(8), 1227. https://doi.org/10.3390/jcm8081227