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

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] Group 1: Clinical Trial Results - The approval follows the successful completion of Phase 3 clinical trials, with the first key Phase 3 study (BRIO I) demonstrating that the combination therapy is more effective than individual active drug compounds [1] - In the second placebo-controlled Phase 3 study (BRIO II), BRIMOCHOL PF met all primary endpoints for near vision improvement, showing a statistically significant increase in binocular uncorrected near visual acuity (BUCNVA) by three lines or more, while binocular uncorrected distance visual acuity (BUCDVA) did not decrease by one line or more [1] Group 2: Safety and Tolerability - During the monitoring of over 72,000 treatment days in the BRIO II study, BRIMOCHOL PF was well-tolerated, with no treatment-related serious adverse events observed [2] - The incidence of eye redness (conjunctival hyperemia) as a reported adverse event was low, with a rate of 2.8% in BRIMOCHOL PF recipients compared to 10.7% in those receiving only carbachol [2] Group 3: Commercial Strategy - The FDA approval serves as a strong catalyst for the company's commercialization strategy, as it has established a partnership network for BRIMOCHOL PF, including eight commercial partners across the Asia-Pacific region and the Middle East [2] - With FDA recognition, the company anticipates accelerating the market entry of the drug, marking a significant global milestone [2]