Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” 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 today that its Investigational New Drug (“IND”) applications for BRIMOCHOL PF and CARBACHOL PF were approved by the National Medical Products Administration of China (“NMPA”) recently. Based on the Clinical Trial Permission Notification approved by the NMPA, the Company will conduct a clinical trial in China on subjects with presbyopia.

On 25 April 2023, Zhaoke Ophthalmology announced that its partner, Visus Therapeutics Inc. (“Visus”), had announced positive top-line results from its Phase III pivotal BRIO-I trial of BRIMOCHOL PF. BRIO-I met the pre-specified primary study endpoints agreed upon with the FDA in the US and the EMA/MHRA in the EU/UK. BRIMOCHOL PF demonstrated the contribution of elements as a once-daily, fixed-dose combination over both active comparators carbachol and brimonidine monotherapies. In addition to BRIO-I, Visus is currently running BRIO-II, a pivotal Phase III, six-month plus six-month safety and efficacy study. Following the read-out of the vehicle-controlled BRIO-II, Visus expects to file a New Drug Application for BRIMOCHOL PF with the US FDA.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and Chief Executive Officer of Zhaoke Ophthalmology, said, “Presbyopia is the loss of vision associated with aging and is impacting billions of people globally. This includes approximately 600 million adults in China, South Korea and Southeast Asia where there are currently no approved presbyopia-correcting drug solutions. As a result, we are genuinely excited to be among the first wave of companies in the region to focus on providing an alternative treatment for presbyopia patients besides reading glasses as soon as possible. Our IND applications for BRIMOCHOL PF and CARBACHOL PF also position Zhaoke Ophthalmology as the first pharmaceutical company in China with ongoing clinical studies in all three major front-of-the-eye diseases, namely dry eye disease, myopia and presbyopia.”

ABOUT BRIMOCHOL PF AND CARBACHOL PF

BRIMOCHOL PF and Carbachol PF are pupil-modulating eye drops designed to be once-daily, preservative-free therapeutics to correct for the loss of near vision 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 proprietary, preservative-free formulation of carbachol monotherapy. Both investigational therapies reduce the size of the pupil resulting in a “pinhole effect” so that only centrally focused light rays are able to enter the eye, thereby sharpening near and intermediate images. The result is clarity of vision for near tasks like reading or using a smartphone, and intermediate tasks, such as looking at a computer screen. In the VIVID Phase 2 study, both formulations met primary and secondary endpoints, demonstrating a 3-line improvement in near visual acuity with no loss of distance vision out to nine hours.[1] BRIMOCHOL PF and Carbachol PF were well tolerated with no serious adverse events.¹

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 when adults are in their 40s[2] and becomes almost universal by age 50[3]. Presbyopia impacts billions of people globally with approximately 600 million adults affected by it in China, South Korea and Southeast Asia[4]. 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 China, South Korea or Southeast Asia.

About the License Agreement with Visus Therapeutics

In May 2022, the Company signed an exclusive licensing agreement with Visus for the development and commercialization of BRIMOCHOL PF in Greater China, South Korea and selected Southeast Asian territories. For details of the licensing agreement in relation to BRIMOCHOL PF, please refer to “Voluntary Announcement – Reaching Exclusive LicensingAgreement to Commercialize BRIMOCHOL PF and CARBACHOL PF In Greater China,South Korea and Select Southeast Asian Markets for the Treatment of Presbyopia”dated 11 May 2022 [Link].

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Reference

[1] Visus Therapeutics data on file

[2] World report on vision. Geneva: World Health Organization; 2019. License: CC BY-NC-SA 3.0 IGO. Retrieved January 23, 2024, from https://www.who.int/docs/default-source/documents/world-vision-report-post-launch-accessible.pdf?sfvrsn=1b29f0e7_2

[3] 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

[4] Market Scope, Global Presbyopia-Correcting Surgery Market Report. April 2012.