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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

福爾馬製藥和eyenovia計劃在美國推出新獲FDA批准的眼科藥品
Benzinga ·  09/09 15:02

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。


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