TSH Biopharm Announces TFDA Approval of TYRVAYA® Nasal Spray for Dry Eye Treatment
2024.11.18
Taipei, Taiwan, [2024/11/18] – TSH Biopharm (TW-8432) today announced a significant milestone with the approval of TYRVAYA® for Dry Eye Nasal Spray by the Taiwan Food and Drug Administration (TFDA). This marks the second drug approval for TSH this year.
TYRVAYA, a novel nasal spray developed by Oyster Point Pharma, offers a groundbreaking treatment option for millions worldwide suffering from dry eye disease. Having received FDA approval in 2021, TYRVAYA is now poised to transform the lives of Taiwanese patients. Through a strategic partnership with CORXEL Pharmaceuticals, TSH Biopharm accelerated the regulatory process and commercialization of TYRVAYA in Taiwan, securing approval in less than a year.
Dry eye disease is a multifactorial ocular surface disease characterized by a damaged tear film, which causes discomfort and potentially leads to more serious eye problems. TYRVAYA, a highly selective cholinergic agonist, works by stimulating the production of natural tears. In clinical trials involving 1,403 patients, TYRVAYA demonstrated significant improvements in signs and symptoms of dry eye disease as early as two weeks after treatment. Furthermore, after 4 weeks of use, the average amount of natural tear film produced was still significantly increased, highlighting the product’s potential to enhance patients’ quality of life.
Citing data from Fortune Business Insights, TSH Biopharm General Manager Sze Yuan Yang noted that the global dry eye disease treatment market is poised to reach $11.3 billion by 2030, driven by a 7% compound annual growth rate. Moreover, statistics from Taiwan's Ministry of Health and Welfare indicate a 70% increase in outpatient visits for dry eye disease over the past decade, indicating that market demand is rising.
"With TYRVAYA, we are excited to offer a revolutionary new treatment option for dry eye disease patients in Taiwan," said Yang. "This approval underscores our commitment to addressing unmet medical needs and further strengthens our market position."
About TYRVAYA® Nasal Spray
TYRVAYA nasal spray is a highly selective cholinergic agonist that is approved by Taiwan TFDA, U.S. FDA, and China NMPA, 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. Guided by a mission of dedication, innovation, and excellence, the company strives to provide superior healthcare services across all stages of medical care—before, during, and after treatment. With a patient-centered approach at the core of its product development, TSH Biopharm is committed to advancing niche products through clinical research and commercialization. The company aspires to be the best partner for international startups seeking collaboration opportunities in Asia. For more information, please visit www.tshbiopharm.com.
Reference
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