HONG KONG, 11 April 2025 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology”, “Zhaoke” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs, is pleased to announce that the first patient was recently enrolled in the Phase II clinical trial of one of Zhaoke’s core drug candidates, BRIMOCHOLTM PF, an innovative treatment for presbyopia. At the same time, the Company is also delighted to announce a partnership with Lunatus Marketing & Consulting FZCO (“Lunatus”) based in Dubai (UAE), a leading pharmaceutical company in the Middle East and North Africa region, for the commercialization of BRIMOCHOLTM PF in the Gulf Cooperation Council (“GCC”) countries.
Zhaoke Ophthalmology Recruits First Patient for Phase II Clinical Trial for BRIMOCHOLTM PF
Upon receiving the regulatory approval from the National Medical Products Administration (“NMPA”) of China for the Investigational New Drug (“IND”) applications for BRIMOCHOLTM PF in 2024, Zhaoke Ophthalmology recently began the Phase II clinical trial.
The Phase II clinical trial is a multi-centre, randomized, double-blind, crossover and placebo-controlled study. The main objective of the trial is to evaluate the efficacy and safety of BRIMOCHOLTM PF eye drop in Chinese presbyopia patients. Led by Professor Qu Jia from Eye Hospital of Wenzhou Medical University as the Principal Investigator, the trial will involve 14 centres and will enrol 119 patients. On 24 March 2025, the Company recruited the first patient for the trial.
Entering into distribution and supply agreement with Lunatus for GCC Market Expansion
Simultaneously with advancing the clinical development of BRIMOCHOLTM PF, Zhaoke Ophthalmology is excited to announce the third out-licensing deal for BRIMOCHOLTM PF, opening a new market for its drug.
On 21 March 2025, Zhaoke Ophthalmology entered into a distribution and supply agreement with Lunatus for the commercialization of BRIMOCHOLTM PF in the GCC countries. Under the terms of the agreement, Zhaoke Ophthalmology will grant Lunatus the exclusive rights to import, distribute, promote, market and sell BRIMOCHOLTM PF in the Kingdom of Saudi Arabia, the UAE, Kuwait, Oman, Bahrain, and Qatar. As part of the agreement, Lunatus will obtain the relevant local drug registrations on behalf of the Company. Zhaoke will be eligible to receive milestone payments based on certain achievements.
Previously, Zhaoke Ophthalmology established partnerships with Kwangdong Pharmaceutical Co., Ltd., a leading Korean pharmaceutical company, and AFT Pharmaceuticals Limited, a leading manufacturer and distributor of healthcare products based in New Zealand, for the commercialization of BRIMOCHOLTM PF in the South Korean market and the ANZ (Australia and New Zealand) markets respectively.
Progress in International Markets with NDA Submission to FDA by Tenpoint Therapeutics
This drug has also achieved notable progress in international markets. On 8 April 2025, Zhaoke Ophthalmology’s partner Tenpoint Therapeutics Ltd. (“Tenpoint”), announced that it had submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for BRIMOCHOLTM PF to treat presbyopia. Tenpoint was created through the merger of Tenpoint Therapeutics Ltd. and Visus Therapeutics, Inc., and is a global, clinical-stage biotech company developing groundbreaking treatments to address issues resulting from the aging of eyes.
Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, commented, “Zhaoke is excited about our progress made with BRIMOCHOLTM PF, one of our most important innovative assets. The recruitment of the first patient for BRIMOCHOLTM PF’s Phase II clinical study marks another important milestone for Zhaoke as we continue to progress towards the drug's arrival and commercialization in China. We are also encouraged by our partner Tenpoint’s recent successful NDA submission for BRIMOCHOLTM PF to the FDA, as it strengthens our confidence in the drug. Meanwhile, I am also thrilled about our strategic partnership with Lunatus, which opens a new chapter for Zhaoke as we expand into the Middle East markets. Adhering to our globalization approach, we have been dedicating efforts in expanding our global footprints and monetizing our drug assets.”
Dr. Lina Kouatly, President and CEO of Lunatus, said, “We are thrilled to collaborate with Zhaoke as the marketing authorization holder for BRIMOCHOLTM PF, a groundbreaking eye drop developed for the treatment of presbyopia. This partnership aligns seamlessly with our mission to introduce innovative healthcare solutions to the Middle East market, addressing unmet medical needs and enhancing the quality of life for patients across the region.”
Henric Bjarke, Chief Executive Officer at Tenpoint Therapeutics, commented, “The submission of the U.S. NDA for BRIMOCHOLTM PF marks a significant milestone for our company. As we accelerate the build-out of our commercial team in preparation for the anticipated launch in the first half of 2026, we look forward to collaborating closely with the FDA throughout the NDA review process. We are also excited about the progress made by our partner Zhaoke Ophthalmology in advancing the clinical development and commercialization of this innovative treatment.”
About BRIMOCHOLTM PF
BRIMOCHOLTM PF is a pupil-modulating eye drop designed to be a once-daily, preservative-free therapeutic to correct the loss of near vision associated with presbyopia. It is a fixed-dose combination of carbachol (a cholinergic agent) and brimonidine tartrate (an alpha-2 agonist). BRIMOCHOLTM PF reduces the size of the pupil, resulting in a “pinhole effect” which only allows centrally focused light rays to enter the eye, thereby sharpening both near and intermediate images.
About Presbyopia
Presbyopia is the 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 Lunatus Marketing & Consulting FZCO
Lunatus is a leading healthcare enterprise that serves as the essential bridge connecting international healthcare companies to the dynamic markets of the Arabian Gulf and Middle East. Headquartered in Dubai with a strong regional presence, Lunatus offers turnkey solutions ensuring seamless market entry and long-term growth for its partners, as well as a portfolio of innovative and advanced Lunatus products.
Lunatus’ strength lies in the professionalism and dedication of its team. This expertise has propelled partnered brands to leading positions in their respective categories, including consistent top-three rankings in IQVIA reports. By leveraging deep local knowledge and an expansive network of partners, Lunatus delivers agile, scalable, and impact-driven strategies designed to meet the unique needs of the region’s healthcare landscape.
About Tenpoint Therapeutics Ltd.
Tenpoint Therapeutics Limited is a global, clinical-stage biotech company developing groundbreaking treatments to rejuvenate vision in the aging eye. Its pipeline includes paradigm-shifting treatments for ophthalmic indications with the greatest need and global market potential, including presbyopia, cataracts and geographic atrophy. Tenpoint’s leadership team includes ophthalmic industry luminaries with track records of successful approvals and commercialization of blockbuster drugs. A privately held company, Tenpoint Therapeutics is backed by AdBio Partners, British Patient Capital, Eight Roads, EQT Life Sciences, F-Prime Capital, Hillhouse Capital Management, Qiming Venture Partners USA, Sofinnova Partners, and UCL Technology Fund. To learn more, visit 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-ccessible.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.
