TSH Biopharm (東生華) announced yesterday (18th) that its innovative nasal spray for dry eye treatment, TYRVAYA, branded as "星特潤" in Taiwan, has received approval as a new drug from Taiwan's Food and Drug Administration (TFDA). This marks the second successful drug approval obtained by TSH Biopharm this year.

According to Sze Yuan Yang (楊思源), General Manager of TSH Biopharm, TYRVAYA was first approved by the U.S. Food and Drug Administration (FDA) in 2021 and has since been successfully launched in the United States. Developed by the U.S.-based pharmaceutical company Oyster Point Pharma, this groundbreaking treatment will provide a novel therapeutic option for patients suffering from dry eye in Taiwan.

Last year, TSH Biopharm partnered strategically with Ji Xing Pharmaceuticals (箕星藥業) to expedite the regulatory approval and commercialization process for TYRVAYA in Taiwan. Through this collaboration, TSH Biopharm obtained the drug approval within less than a year, demonstrating the company’s efficiency and execution capabilities in introducing new drugs and expanding market reach.

Dry eye disease is a complex, multifactorial condition affecting the ocular surface, often characterized by tear film dysfunction that significantly impacts patients’ quality of life. TYRVAYA represents a highly selective cholinergic receptor agonist that stimulates the production of natural tears, addressing this unmet medical need.

Clinical trials involving 1,403 patients with dry eye showed that after just two weeks of using TYRVAYA, both symptoms and signs of the condition improved. Continued use for four weeks further enhanced natural tear production, highlighting the treatment's potential to significantly improve patients' quality of life.

Resource: 東生華 乾眼症藥獲TFDA核准將上市