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 researching and developing, manufacturing and commercializing 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 parts of Southeast Asia. BRIMOCHOL PF and Carbachol PF are investigational preservative-free therapeutic products designed to be 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 specified territories, and then for product commercialization activities. Visus will receive an upfront payment of $15 million and potentially receive up to $115 million in regulatory, marketing and sales-focused stages. In addition, Visus will earn tiered royalties on future sales of these products in the contracted territories. ZKO will leverage the extensive clinical development experience and plans Visus has in place for its enrolling Phase 3 studies to meet required clinical requirements and bring products to market quickly.
“We are thrilled to partner with Zhaoke Ophthalmology, an innovation-driven company with a highly experienced business team and strong research, clinical and manufacturing infrastructure,” said Ben Bergo, Co-Founder and Chief Executive Officer. from Visus Therapeutics. “Our market research indicates that there is strong demand for a long-acting eye drop that corrects presbyopia in China, and we are excited to collaborate with Zhaoke Ophthalmology to accelerate clinical development and launch our lead candidates in Greater China, South Korea and select Southeast Asian Markets.
“Zhaoke Ophthalmology is excited to join Visus in potentially launching the first once-daily presbyopia corrective eye drops in Greater China, South Korea and select Southeast Asian markets. After extensive analysis of other presbyopia-correcting eye drops in development, Zhaoke Ophthalmology is confident that BRIMOCHOL PF and Carbachol PF have the potential to become best-in-class medications for the treatment of presbyopia, which is backed by Visus’ unparalleled management team experience in the ophthalmology category,” said Dr. Li Xiaoyi (Benjamin), Chairman of the Board and General Manager of Zhaoke Ophthalmology Limited. “We will become the leading ophthalmic pharmaceutical company in China with innovative drugs in advanced clinical development covering the three main fronts of eye diseases, namely dry eye, myopia and presbyopia. We will continue to expand our pipeline of leading ophthalmic actives to the front and back of the eye and bring these promising investigational therapeutics to market in China and beyond as quickly as possible. »
ZKO’s clinical development plans include submitting a new drug application to the China Drug Evaluation Center for CsA ophthalmic gel for short-term dry eye, continuing to enroll patients for the study of phase 3 NVK002 for myopia, as well as the launch of the clinical study in China. for presbyopia corresponding to the ongoing Phase 3 study of BRIMOCHOL PF and Carbachol PF in the United States.
Presbyopia is the loss of near vision associated with aging, which makes it difficult to perform tasks such as reading fine print. It usually starts when the adults are in their 40s1 and becomes almost universal at age 50.2 Presbyopia affects more than 2.1 billion people worldwide3 with approximately 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 impractical or prefer not to wear them for aesthetic reasons. There are currently no approved presbyopia corrective treatments in China, South Korea, or Southeast Asia.
About BRIMOCHOL™ PF and Carbachol PF
BRIMOCHOL™ PF and Carbachol PF are pupil modulating eye drops designed as once-daily, preservative-free therapeutics to correct near vision loss associated with presbyopia. BRIMOCHOL PF is a fixed dose combination of carbachol (a cholinergic agent) and brimonidine tartrate (an alpha-2 agonist). Carbachol PF is a patented preservative-free formulation of carbachol monotherapy. Both experimental therapies reduce the size of the pupil, resulting in a “pinhole effect” so that only centrally focused light rays can enter the eye, thus emphasizing near and intermediate images. The result is clarity of vision for close tasks like reading or using a smartphone, and tasks in between, like looking at a computer screen. In the Phase 2 VIVID study, both formulations met both primary and secondary endpoints, demonstrating a 3-line improvement in near visual acuity with no loss of distance vision for up to nine hours.4 BRIMOCHOL PF and Carbachol PF were well tolerated with no serious adverse events. 4 Phase 3 pivotal trials began in March 2022, with interim preliminary data expected in Q4 2022.
About Visus Therapeutics
With offices in Seattle, Washington, and Irvine, California, Visus Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative ophthalmic therapies to improve vision for people around the world. The company is developing novel, once-daily pupil modulating therapies designed 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 LinkedInTwitter (@VisusTx) and instagram.
About Zhaoke Ophthalmology Limited
Founded in 2017, Zhaoke Ophthalmology Limited (SEHK:6622) is a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs worldwide . The company was listed on the main board of the Hong Kong Stock Exchange on April 29, 2021. Zhaoke Ophthalmology has a comprehensive portfolio of innovative and generic medicines covering five major eye diseases both front and back of the eye. eye. Many drugs are produced in its state-of-the-art and fully functional CMC and production facilities in Nansha, Guangzhou. For more information, please visit www.zkoph.com.
1 World Vision Report. (2019). Retrieved 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 representative 2, 278 (2012). https://doi.org/10.1038/srep00278
3 Market Scope, Global Corrective Presbyopia Surgery Market Report. April 2012.
4 Visus Therapeutics data archived.