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