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]
兆科眼科-B(06622)：Tenpoint接获FDA在美国就BRIMOCHOL PF发出的批准