晖致RYZUMVI获FDA批准新增老花眼适应症 为该用途唯一商业化产品再拓市场
Pittsburgh讯——晖致公司（Viatris，纳斯达克：VTRS）10月16日经PR Newswire宣布，美国食品药品监督管理局（FDA）已批准其RYZUMVI（0.75%酚妥拉明滴眼液）用于治疗成人老花眼（presbyopia）。该药此前已在美国获批用于药物诱导的瞳孔散大，是目前美国唯一商业化供应该用途的FDA批准产品，此次获批将其适应症扩展至老花眼。
RYZUMVI由Opus Genetics开发，晖致依据双方的全球许可协议持有该产品在美国的独家商业化权利。晖致表示，正在为该药的老花眼适应症在美国物色商业化合作伙伴。公告披露的老花眼临床安全性数据显示，常见不良反应包括结膜充血（发生率21%）和滴药部位刺激（16%）。
晖致总部位于美国，在Pittsburgh、上海和海得拉巴设有全球中心，产品组合涵盖品牌药、仿制药、生物类似药和非处方药等。老花眼是随年龄增长出现的近视力下降，晖致称此次批准扩大了该药在美国眼科市场的应用范围。
Viatris Wins FDA Approval of RYZUMVI for Presbyopia, Expanding Its Eye-Care Line
PITTSBURGH — Viatris Inc. (Nasdaq: VTRS) announced on October 16 via PR Newswire that the U.S. Food and Drug Administration has approved RYZUMVI (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia in adults. The product was already approved in the United States for pharmacologically induced mydriasis and is the only commercially available FDA-approved product for that use; the new decision expands its indications to presbyopia.
RYZUMVI was developed by Opus Genetics, and Viatris holds exclusive U.S. commercialization rights under a global licensing agreement between the companies. Viatris said it is exploring a U.S. partner to commercialize the product for presbyopia. Safety data in the release showed conjunctival hyperemia in 21% of patients and instillation site irritation in 16%.
Viatris is headquartered in the United States with global centers in Pittsburgh, Shanghai and Hyderabad, and a portfolio spanning branded medicines, generics, biosimilars and over-the-counter products. Presbyopia is the age-related loss of near vision.
发布：GSM·美国（发布链接）
图片来源：晖致公司官方标志 / Viatris official logo
GSM Global · 本篇英文版 English edition of this story
