ZHAOKE OPHTH-B (06622) announced that its partner, Tenpoint Therapeutics, Ltd. (Tenpoint), has received regulatory approval from the U.S. Food and Drug Administration (FDA) for the commercialization of carbachol and brimonidine tartrate ophthalmic solution (2.75%/0.1%). Known as BRIMOCHOL™ PF during clinical trials, this eye drop will be marketed in the United States under the brand name YUVEZZI™, serving as an innovative treatment for presbyopia. This approval follows Tenpoint's successful completion of Phase 3 clinical trials. The first key Phase 3 BRIO I study demonstrated that the combination therapy offered advantages over the individual active ingredient compounds. In the second placebo-controlled Phase 3 BRIO II study, BRIMOCHOL™ PF met all primary endpoints for improvement in near vision, showing a statistically significant improvement of three lines or more in binocular uncorrected near visual acuity (BUCNVA), with no loss of one line or more in binocular uncorrected distance visual acuity (BUCDVA). Furthermore, BRIMOCHOL™ PF demonstrated a favorable tolerability profile across more than 72,000 treatment days monitored in the BRIO II study, with no treatment-related serious adverse events observed. Ocular redness was not a commonly reported side effect in the drug's clinical trials. The reporting rates for adverse events of ocular hyperemia (eye redness) were low in both the BRIO I and BRIO II studies. In the BRIO II study, the incidence of ocular hyperemia (eye redness) adverse events reported by subjects receiving BRIMOCHOL™ PF (2.8%) was lower than that reported by subjects receiving carbachol alone (10.7%). For Zhaoke Ophthalmology, this approval serves as a powerful catalyst prior to finalizing its commercialization strategy. The company has already established a partnership network for BRIMOCHOL™ PF, which currently includes eight commercial partners across the Asia-Pacific region (including South Korea, Australia, New Zealand, Thailand, Indonesia, Taiwan/Hong Kong/Macau, Singapore, and Vietnam) and the Middle East. Bolstered by FDA recognition, Zhaoke anticipates it can accelerate the drug's market entry, marking a significant global milestone.