SEATTLE & HONG KONG–(BUSINESS WIRE)–Visus Therapeutics, Inc. (“Visus”), a clinical-stage pharmaceutical company focused on developing innovative ophthalmic therapies to improve the vision of people around the world, and Zhaoke Ophthalmology Limited (“ZKO”) , a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of treatments that address significant unmet medical needs, today announced an exclusive license agreement for the development and commercialization of BRIMOCHOL™ PF and Carbachol PF in Greater China, South Korea and select known in Southeast Asia. BRIMOCHOL PF and Carbachol PF are investigational, preservative-free therapeutics developed as long-acting, once-daily eye drops to correct near vision loss associated with presbyopia.
Under the terms of the agreement, ZKO will be responsible for the clinical development and regulatory approval of BRIMOCHOL PF and Carbachol PF in the designated territories and thereafter for the commercialization activities of the products. Visus will receive an upfront payment of US$15 million and potentially up to US$115 million in regulatory, commercialization and sales-oriented milestones. In addition, Visus will receive tiered royalties on future sales of these products in the contract territories. ZKO will leverage the significant clinical development experience and plans implemented by Visus for its currently ongoing Phase 3 studies to meet the required clinical requirements and bring the products to market quickly.
“We are excited to partner with Zhaoke Ophthalmology, an innovation-driven company with a highly experienced commercial team and a robust research, clinical and manufacturing infrastructure,” said Ben Bergo, co-founder and chief executive officer of Visus Therapeutics. “Our market research shows that there is a strong demand for long-acting eye drops to correct presbyopia in China, and we look forward to working with Zhaoke Ophthalmology to accelerate clinical development and expand our lead candidates in Greater China, South Korea and select countries.” to bring to market Southeast Asian markets.”
“Zhaoke Ophthalmology is excited to partner with Visus to potentially launch the first once-a-day eye drops for presbyopia correction in Greater China, South Korea and select Southeast Asian markets. After extensive analysis of other eye drops in development to correct presbyopia, Zhaoke Ophthalmology is confident that BRIMOCHOL PF and Carbachol PF have the potential to become the best-in-class drugs for the treatment of presbyopia, backed by Visus’ unparalleled leadership team with experience in the field Ophthalmology category,” said Dr. Li Xiaoyi (Benjamin), Chairman and Chief Executive Officer of Zhaoke Ophthalmology Limited. “We will be the first ophthalmic pharmaceutical company in China with innovative drugs in late-stage clinical development covering the three major frontal diseases of the eye, namely dry eye, myopia and presbyopia. We will continue to expand our world-leading pipeline of ophthalmic compounds in both anterior and posterior regions and bring these promising investigational therapeutics to market in China and beyond as quickly as possible.”
ZKO’s clinical development plans include the near-term submission of a new drug application to the Center for Drug Evaluation in China for CsA Ophthalmic Gel for dry eye, continued patient enrollment in the Phase 3 NVK002 study in myopia, and the start of the clinical trial in China for presbyopia according to the ongoing Phase 3 study of BRIMOCHOL PF and Carbachol PF in the United States.
Presbyopia is the age-related loss of near vision that makes it difficult to perform tasks such as reading fine print. It typically begins when adults are in their 40s1 and becomes almost universal by age 50.2 Presbyopia affects more than 2.1 billion people worldwide3 with about 600 million patients in China, South Korea and Southeast Asia.4 Reading glasses are the most common solution for near vision correction. However, many people find glasses uncomfortable or prefer not to wear them for aesthetic reasons. There are currently no approved therapeutics to correct presbyopia in China, South Korea or Southeast Asia.
About BRIMOCHOL™ PF and Carbachol PF
BRIMOCHOL™ PF and Carbachol PF are pupil modulating eye drops developed as once-daily, preservative-free therapeutics to correct the near vision loss associated with presbyopia. BRIMOCHOL PF is a fixed-dose combination of carbachol (a cholinergic drug) and brimonidine tartrate (an alpha-2 agonist). Carbachol PF is a proprietary, preservative-free formulation of carbachol monotherapy. Both investigational therapies reduce the size of the pupil, resulting in a “pinhole effect” that allows only centrally focused light rays to enter the eye, resulting in sharper near and intermediate images. The result is a clear view for close-up tasks like reading or using a smartphone, and intermediate tasks like looking at a computer screen. In the Phase 2 VIVID study, both formulations met the primary and secondary endpoints, demonstrating a 3-line improvement in near vision with no loss in distance vision for up to nine hours.4 BRIMOCHOL PF and Carbachol PF were well tolerated with no serious side effects. 4 Pivotal Phase 3 studies began in March 2022, with preliminary topline data expected in Q4 2022.
About Vision Therapeutics
Visus Therapeutics, with offices in Seattle, Washington and Irvine, California, is a clinical-stage pharmaceutical company focused on developing innovative ophthalmic therapies to improve the vision of people around the world. The company is developing novel once-daily pupil modulating therapeutics to correct near vision loss associated with presbyopia. In parallel, Visus Therapeutics is focused on advancing its pipeline of early-stage ophthalmic drug candidates with applications in corneal wound healing, glaucoma and age-related macular degeneration. For more information, visit: www.visustx.com and follow us on LinkedIn, Twitter (@VisusTx) and Instagram.
About Zhaoke Ophthalmology Limited
Founded in 2017, Zhaoke Ophthalmology Limited (SEHK: 6622) is a leading ophthalmology pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs in the world. The company was listed on the main board of the Hong Kong Stock Exchange on April 29, 2021. Zhaoke Ophthalmology has a comprehensive drug portfolio of innovative and generic treatments covering five major eye conditions in both the anterior and posterior regions of the eye. Many of the drugs are manufactured at the state-of-the-art and fully operational CMC and manufacturing facilities in Nansha, Guangzhou. Visit www.zkoph.com for more information.
1 World report to see. (2019). Retrieved on April 29, 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 effects of aging on the human eye. Scientific Rep 2, 278 (2012). https://doi.org/10.1038/srep00278
3 Market Scope, Global Presbyopia-Correcting Surgery Market Report. April 2012.
4 Visus Therapeutics data are available.