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 that the Company has entered into an exclusive license, supply and distribution agreement (“the Agreement”) with Eyedetec Medical, Inc. (“Eyedetec Medical”), a leading US-based company specializing in medical devices for the treatment of dry eye disease (“DED”) and meibomian gland dysfunction.

Under the terms of the Agreement, Eyedetec Medical grants Zhaoke Ophthalmology exclusive rights to register, import, promote, distribute, market and sell the Eye Lipid Mobilizer™ (“ELM™”), a medical device that is designed to treat DED and meibomian gland dysfunction, in Greater China (mainland China, Hong Kong, Macau and Taiwan), South Korea and the ASEAN countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam) ("Territory”).

ELM is a proprietary medical device that is intended to treat moderate to severe DED by stabilizing the oil layer of the eye’s tear film. The result is decreased tear evaporation and a healthy ocular surface. By uniquely combining several mechanisms, ELM delivers heat to the eyelids to lower the viscosity of the oil (i.e. meibum). Next, it utilizes a novel form of resonant frequency stimulation (vibration at a range of frequencies to induce liquefaction and mobilization of the oil in the meibomian glands as a result of shear thinning). Finally, the lacrimal functional unit is activated through neuromodulation to induce expression of meibum from the meibomian glands. ELM incorporates these three integrated mechanisms within one device that is comfortably and safely worn over patients’ closed eyelids.

Eyedetec Medical is currently preparing for ELM’s U.S. FDA premarket submission. Upon clearance in the U.S., ELM will become the first and only physician-prescribed therapy that treats the root cause of dry eye disease at home. Eyedetec Medical’s clinical IRB study conducted in the U.S. demonstrated compelling evidence of efficacy of the device, and a human factor study demonstrated that ELM is intuitive and easy for patients to learn and use.

ELM has already received high recognition from the industry, including winning second place (out of 50 submissions) in The Winning Pitch Challenge presentations at Eyecelerator 2023 during ASCRS (American Society of Cataract and Refractive Surgery) on May 4 in San Diego.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “We are delighted to partner with Eyedetec Medical to have the exclusive rights to commercialize ELM in the Greater China, South Korea and the ASEAN countries. Zhaoke Ophthalmology is strategically focused on treatments that cover both the front and back-of-the-eye ophthalmic diseases, including DED.

We always strive to deliver the best treatment options with a combination of drugs and medical devices to patients. This partnership has expanded our medical device portfolio and enabled us to cover a wider range of severity of DED patients in the region. ELM will become an integral part of our DED portfolio, which currently comprises Baodeshi (堡得视®) branded eyepatches selling on Tmall, our lead innovative asset Cyclosporine A Ophthalmic Gel under NDA (New Drug Application) review by the NMPA, and other innovative asset candidates with different mechanisms of action. We will continue to explore partnership opportunities with both domestic and international pharmaceutical and medical device companies, and achieve our goal to become a global leader in ophthalmology.”

Dr. Barry J Linder, MD, MS, Founder, President & CEO of Eyedetec Medical, said, “Eyedetec views this new partnership with Zhaoke Ophthalmology as a major inflection point in our business plan to bring highly innovative solutions for dry eye patients to the marketplace. With the ELM, we have reimagined dry eye treatment, and have created a solution that is remarkably effective, affordable, and convenient. As the incidence of evaporative dry eye disease continues to grow around the world, the markets in Greater China, S Korea, and ASEAN countries are especially attractive, with large numbers of tech savvy patients that want innovative treatments delivered in the comfort of their homes. We look forward to working with Zhaoke to launch ELM in the Territory.”

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About Eyedetec Medical, Inc.
Eyedetec Medical, Inc., is a medical device company with a mission to research and develop a portfolio of novel technologies to address the growing problem of dry eye disease. For mild dry eye disease, Eyedetec currently sells the EyeGiene® Insta-Warmth System, comprised of a convenient, portable, reusable eye mask, with single use, disposable Warming Wafers calibrated to deliver therapeutic heat to the surface of the eyelids.
For more information, please visit www.eyedetec.com and www.eyegiene.com .