Core Insights - Tenpoint Therapeutics, Ltd. has received FDA approval for the commercialization of BRIMOCHOL™ PF (2.75%/0.1%), an innovative eye drop for the treatment of presbyopia, which will be marketed as YUVEZZI™ in the U.S. [1][2] - The approval follows the successful completion of Phase 3 clinical trials, with the BRIO I study demonstrating the combination therapy's superiority over individual therapies [1] - The BRIO II study showed that BRIMOCHOL™ PF significantly improved binocular uncorrected near visual acuity (BUCNVA) by three lines or more, with no significant decline in binocular uncorrected distance visual acuity (BUCDVA) [1] Clinical Trial Results - In the BRIO II study, BRIMOCHOL™ PF was well-tolerated, with no serious treatment-related adverse events reported during over 72,000 treatment days [2] - The incidence of eye redness (conjunctival hyperemia) as a side effect was low, with a report rate of 2.8% for BRIMOCHOL™ PF compared to 10.7% for those receiving only carbachol [2] Commercial Strategy - The approval serves as a strong catalyst for the company's commercialization strategy, having established a partnership network that includes eight commercial partners across the Asia-Pacific region and the Middle East [2] - With FDA recognition, the company anticipates accelerating the market entry of BRIMOCHOL™ PF, marking a significant global milestone [2]

Core Insights - Tenpoint Therapeutics, Ltd. has received FDA approval for the commercialization of BRIMOCHOL™ PF (2.75%/0.1%), an innovative eye drop for the treatment of presbyopia, which will be marketed as YUVEZZI™ in the U.S. [1][2] - The approval follows the successful completion of Phase 3 clinical trials, with the BRIO I study demonstrating the combination therapy's superiority over individual therapies [1] - The BRIO II study showed significant improvement in binocular uncorrected near visual acuity (BUCNVA), with a statistically significant increase of three lines or more, while binocular uncorrected distance visual acuity (BUCDVA) did not decline by one line or more [1] Clinical Trial Results - In over 72,000 treatment days monitored during the BRIO II study, BRIMOCHOL™ PF exhibited good tolerability, with no serious treatment-related adverse events observed [2] - The incidence of eye redness as a side effect was low, with only 2.8% of subjects experiencing this adverse event compared to 10.7% in those receiving only carbachol [2] Commercial Strategy - The FDA approval serves as a strong catalyst for the company's commercialization strategy, with established partnerships across the Asia-Pacific region and the Middle East [2] - The company anticipates that FDA recognition will expedite the market entry of BRIMOCHOL™ PF, marking a significant global milestone [2]

Zhaoke Ophthalmology Limited （於英屬處女群島註冊成立並於開曼群島存續的有限公司） 兆科眼科有限公司 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 對 因 本 公 告 全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 （股份代號：6622） 兆科眼科的夥伴TENPOINT THERAPEUTICS, LTD. 接 獲FDA在美國 就BRIMOCHOL™ PF發出的批准 本 公 告 由 兆 科 眼 科 有 限 公 司（「本公司」）董 事 會（「董事會」）自 願 作 出。 本 公 司 董 事 會 欣 然 宣 佈，本 公 司 的 夥 伴Tenpoint Therapeutics, Ltd.（「Tenpoint」）已 接 獲 美 國 食 品 藥 品 監 督 管 理 局（「FDA」）批 准 商 業 化 卡 巴 膽 鹼 及 酒 石 酸 溴 莫 尼 丁 滴 眼 液（2.75%/0.1%）的 監 管 批 准。此 滴 眼 液 於 臨 床 試 驗 期 間 ...