Core Viewpoint - Tenpoint Therapeutics, Ltd. has received FDA approval for the commercialization of BRIMOCHOL PF, an innovative eye drop treatment for presbyopia, which will be marketed as YUVEZZI in the U.S. [1] Group 1 - The approval follows the successful completion of Phase 3 clinical trials, with the first key Phase 3 study (BRIO I) demonstrating the combination therapy's superiority over individual therapies [1] - The second Phase 3 study (BRIO II) achieved 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 - During the BRIO II study, BRIMOCHOL PF showed good tolerability with no serious treatment-related adverse events reported, and the incidence of eye redness was low [2] - The report rate of eye redness for subjects receiving BRIMOCHOL PF was 2.8%, significantly lower than the 10.7% for those receiving only carbachol [2] Group 3 - This FDA approval serves as a strong catalyst for the company's commercialization strategy, with a partnership network established across the Asia-Pacific region and the Middle East, including eight commercial partners [2] - With FDA recognition, the company anticipates accelerating the market entry of BRIMOCHOL PF, marking an important global milestone [2]
兆科眼科-B(06622)：Tenpoint接获FDA在美国就BRIMOCHOL? PF发出的批准