The companies will collaborate to commercialize therapeutic option in Greater China, South Korea and Select Southeast Asian Markets for the treatment of presbyopia, expanding access to long-acting, presbyopia-correcting eye drops for approximately 600 million patients.
Visus Therapeutics Inc. and Zhaoke Ophthalmology Limited (“ZKO”) today announced an exclusive licensing agreement for the development and commercialization of BRIMOCHOL PF and Carbachol PF in Greater China, South Korea and select Southeast Asian territories.
According to Visus, BRIMOCHOL PF and Carbachol PF are investigational, preservative-free therapeutics designed to be long-acting, once-daily eye drops to correct for the loss of near vision associated with presbyopia.
Under the terms of the agreement, ZKO will be responsible for clinical development and regulatory approval for BRIMOCHOL PF and Carbachol PF in the specified territories, and subsequently the commercialization activities for the products. Visus will receive an upfront payment of $15 million and will potentially receive up to $115 million in regulatory, commercialization and sales-driven milestones. Additionally, Visus will earn tiered royalties on future sales of these products in the contracted territories. ZKO will leverage the considerable clinical development experience and plans that Visus has implemented for its currently enrolling Phase 3 studies to fulfill the requisite clinical requirements and bring the products to market quickly.
ZKO’s clinical development plans include submitting a new drug application to the Center for Drug Evaluation in China for CsA Ophthalmic Gel for dry eye in the near term, continuing patient recruitment for NVK002 Phase 3 study for myopia, as well as launching the clinical study in China for presbyopia corresponding to the ongoing Phase 3 study of BRIMOCHOL PF and Carbachol PF in the United States.
Ben Bergo, co-founder and chief executive officer at Visus Therapeutics, noted that the company was existed about the opportunity to work with ZKO.
“Our market research indicates there is high demand for a long-acting, presbyopia-correcting eye drop in China, and we are excited to collaborate with Zhaoke Ophthalmology to accelerate the clinical development and launch our lead candidates in Greater China, South Korea and select Southeast Asian markets,” he said in a statement.
“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 the best-in-class drugs for the treatment of presbyopia, which is backed by the Visus leadership team’s unparalleled experience in the ophthalmology category,” Dr. Li Xiaoyi (Benjamin), chairman of the board of directors and CEO at Zhaoke Ophthalmology Limited, said in the release. . “We will become the first ophthalmic pharmaceutical company in China with innovative drugs in advanced clinical development covering the three major front of the eye diseases, namely, dry eye, myopia and presbyopia. We will continue to further expand our world-leading pipeline of ophthalmic assets in both the front and back of the eye and advance these promising investigational therapeutics to market in China and beyond as quickly as possible.”