Formosa Pharma and Eyenovia Set to Launch New FDA-Approved Ophthalmic Drug in US
Formosa Pharma and Eyenovia Set to Launch New FDA-Approved Ophthalmic Drug in US
Formosa Pharmaceuticals, Inc. (hereinafter referred to as "Formosa Pharma," 6838.TW) announced the successful first shipment to the United States of its new ophthalmic drug, Clobetasol Propionate Ophthalmic Suspension, 0.05% (APP13007), manufactured by Bora Pharmaceuticals Ophthalmic (hereinafter referred to as "Bora," 6472.TW). Formosa Pharma's U.S. partner, Eyenovia, Inc. (NASDAQ:EYEN), has initiated the pre-launch activities for APP13007 and is expected to begin commercialization in late September.
臺灣福姆製藥股份有限公司(以下簡稱"福姆製藥",6838.TW)宣佈其由寶辣藥品眼科(以下簡稱"寶辣",6472.TW)生產的新眼科藥物克比他唑丙酸酯眼用懸濁液0.05%(APP13007)成功首次向美國發貨。福姆製藥的美國合作伙伴eyenovia公司(NASDAQ:EYEN)已經啓動了APP13007的預發行活動,並預計將於九月底開始商業化。
APP13007, developed through Formosa Pharma's proprietary APNT nanotechnology platform, is the first drug approved by the U.S. FDA for ophthalmic use utilizing the super-potent corticosteroid, clobetasol propionate. Almost 7 million ophthalmic surgeries are performed annually in the U.S., and the ophthalmic steroid and steroid-combination drug market is valued at USD $1.3 billion. According to a recent survey conducted by Eyenovia of 100 U.S. ophthalmic surgeons, efficacy and cost were identified as the most important factors when choosing a treatment for postoperative inflammation and pain. APP13007 offers a more convenient dosing regimen with its proven efficacy, requiring only twice-daily administration compared to other treatments that require up to four doses per day.
通過福姆製藥專有的APNt納米技術平台開發的APP13007是美國FDA批准的第一種使用超強糖皮質類固醇克比他唑丙酸酯眼用的藥物。美國每年進行近700萬次眼科手術,眼科類固醇和類固醇複合藥物市場價值達到13億美元。根據eyenovia對100位美國眼科外科醫生進行的最近調查,療效和成本被確定爲選擇術後炎症和疼痛治療時最重要的因素。APP13007提供更爲便利的用藥方案,已被證明具有療效,僅需每天兩次給藥,而其他治療可能需要每天多達四次給藥。
譯文內容由第三人軟體翻譯。