HONG KONG, 29 January 2026 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology”, “Zhaoke” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company, is thrilled to announce that its partner Tenpoint Therapeutics, Ltd. (“Tenpoint”) has obtained 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%, which was known as BRIMOCHOL™PF during clinical trials, and which will have the trade name YUVEZZI™ in the U.S. as an innovative drug for the treatment of presbyopia.
This FDA approval represents a major validation for BRIMOCHOLTM PF, a core asset in Zhaoke’s global portfolio. The drug is licensed from Tenpoint, a commercial-ready biotech company focused on groundbreaking therapies for age-related vision conditions.
The approval follows Tenpoint's successful Phase 3 clinical trials. The first pivotal Phase 3 BRIO I study demonstrated the benefit of the combination therapy over the individual monotherapy active drug components. In the second vehicle-controlled Phase 3 BRIO II study, BRIMOCHOLTM PF achieved all primary near-vision improvement endpoints with statistically significant three-lines or greater improvement in binocular uncorrected near visual acuity (BUCNVA), without the loss of one line or more in binocular uncorrected distance visual acuity (BUCDVA).
In addition, BRIMOCHOLTM PF was well-tolerated with no serious treatment-related adverse events observed in the over 72,000 treatment days monitored in the BRIO II study. Eye redness was not a commonly reported side effect in clinical trials of the drug. In BRIO I and BRIO II the reports of adverse events of ocular hyperemia (eye redness) were low. In BRIO II, the rate of reported adverse events of ocular hyperemia (eye redness) was lower in subjects receiving BRIMOCHOLTM PF (2.8%) than carbochol alone (10.7%).
For Zhaoke Ophthalmology, this approval acts as a powerful catalyst for its pre-established commercialization strategy. The Company has built a partnership network for BRIMOCHOLTM PF that now extends to eight commercial partners across Asia-Pacific, including South Korea, Australia, New Zealand, Thailand, Indonesia, the Taiwan/Hong Kong/Macau regions, Singapore, and Vietnam as well as the Middle East. With this FDA endorsement, Zhaoke is anticipated to accelerate the launch of the drug, marking a significant global milestone. This achievement underscores Zhaoke’s successful execution of its globalization strategy, transforming regulatory success into widespread patient access.
Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, commented, “I am delighted for our partner Tenpoint, on receiving this FDA approval. This is a critical milestone for Tenpoint, that reflects their years of dedication and scientific rigor. Beyond its significance in the U.S., this approval provides strong momentum for accelerating the commercialization of BRIMOCHOLTM PF in selected APAC and the Middle East markets where we have carefully built our strategic footprint. This brings us a step closer to delivering a high-quality treatment to the hundreds of million people in these territories of Zhaoke who are affected by presbyopia. We are truly excited about the opportunity to translate this regulatory success into meaningful benefits for patients throughout the region. As our global presence continues to expand, it will enable us to bring Zhaoke’s other innovative products to even more communities, helping us make a lasting difference in eye health.”
About BRIMOCHOLTM PF and BRIO II Phase 3 Study
BRIMOCHOLTM PF is an investigational, preservative-free, once daily eyedrop to correct for the loss of near vision associated with aging. BRIO II is a 3-arm, multicenter, randomized, double-masked, safety and efficacy study of BRIMOCHOLTM PF (carbachol/brimonidine tartrate fixed-dose combination) topical ophthalmic solution vs. carbachol monotherapy topical ophthalmic solution vs. a vehicle topical ophthalmic solution in subjects with emmetropic phakic or pseudophakic presbyopia (NCT05135286). The study enrolled 629 subjects across forty-seven sites in the United States.
About Presbyopia
Presbyopia is the gradual loss of near vision associated with aging, making it difficult to perform tasks like reading fine print. It typically begins in adults in their 40s[1] and becomes almost universal by age 50[2]. Presbyopia impacts billions of people globally[3] with approximately 600 million adults affected in China, South Korea and Southeast Asia[4]. In Australia, the total number of prevalence cases reached over 13.5 million in 2023, according to GlobalData[5]. Reading glasses are the most common solution for near-vision correction; however, many people find glasses inconvenient or prefer not to wear them for aesthetic reasons. There are currently no approved presbyopia-correcting therapeutics in many countries across the Asia-Pacific region.
About Tenpoint Therapeutics Ltd.
Tenpoint Therapeutics Ltd. is a global biotechnology company focused on the commercialization of YUVEZZI™ (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, the first and only dual-agent eye drop for the treatment of presbyopia, a condition that affects nearly 128 million people in the U.S. and approximately 2 billion people globally. By understanding real-world needs and partnering with eye care professionals, Tenpoint is working to bring innovation to the aging eye. For more information, please visit: www.tenpointtherapeutics.com/
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[1] World report on vision. (2019). Retrieved 29 April, 2022, from https://www.who.int/docs/default-source/documents/world-vision-report-post-launch-accessible.pdf?sfvrsn=1b29f0e7_2
[2] Polat, U., Schor, C., Tong, JL. et al. Training the brain to overcome the effect of aging on the human eye. Sci Rep 2, 278 (2012). https://doi.org/10.1038/srep00278
[3] Market Scope, Global Presbyopia-Correcting Surgery Market Report. April 2012.
[4] Tenpoint Therapeutics data on file
[5] GlobalData’s Epidemiology Market Size Search extracted on 18 December 2024.
