Zhaoke Ophthalmology Limited announce that the Investigational New Drug applications of BRIMOCHOL PF and Carbachol PF have been approved by the National Medical Products Administration of China recently. Based on the Clinical Trial Permission Notification approved by NMPA, the Company will conduct the trial in China on subjects with presbyopia. On April 25, 2023, the Company announced that its partner ­ Visus Therapeutics Inc. ("Visus") had announced positive top-line results from its Phase 3 pivotal BRIO-I trial.

BRIO-I met the pre-specified primary study endpoints agreed upon with the US-FDA and EMA/MHRA, demonstrating the contribution of elements for the once-daily, fixed-dose combination, BRIMOCHOL PF, over both active comparators carbachol and brimonidine monotherapies. Besides BRIO-I, Visus is conducting another study, BRIO-II, a Pivotal Phase 3, 6-month plus 6-month safety and efficacy study. Following the read-out of the vehicle-controlled BRIO-II, Visus expects to file a New Drug Application ("NDA") with the US FDA.

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 and becomes almost universal by age 50. Presbyopia impacts billions of people globally with approximately 600 million adults affected in China, South Korea and Southeast Asia.

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.

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 .

BRIMOCHOL PF and Carbachol PF were well tolerated with no serious adverse events. With offices in Seattle, Washington, and Irvine, California, Visus Therapeutics is a clinical stage pharmaceutical company focused on developing multi-targeted ophthalmic therapies for indications in both the front and back of the eye formulated in novel, sustained delivery platforms.