China: On Tuesday, 13^th June 2023, Zhaoke Ophthalmology Limited announced that they have signed an agreement with US-based company Eyedetec Medical for the commercialization of Eye Lipid Mobilizer medical device for the treatment of dry eye disease and meibomian gland dysfunction. After the COVID-19 lockdowns and economic shutdowns, the prevalence of dry eye disease has increased especially among the young population across the globe. Ever since then   millions of people across the globe are suffering from dry eye disease due to their increased uscreen time. Dry Eye Disease is one of the most commonly observed ocular surface disorders and it can affect the layers of tears that cover our cornea. According to the National Health and Wellness Survey, 6.8 percent of the United States adult population (approximately 16.4 million people) have been diagnosed with Dry Eye Disease. Meibomian gland dysfunction affects generally the aging population, and it can affect tear film composition and evaporation of tears.

Eye Lipid Mobilizer is a proprietary medical device that stabilizes the oil layer of the eye's tear film to treat moderate to severe dry eye disease. This causes reduction in tear evaporation. Eye Lipid Mobilizer reduces the viscosity of the oil (meibum) by delivering heat to the eyelids through a novel combination of several mechanisms. Eye Lipid Mobilizer is a single device with three integrated mechanisms that can be worn securely and comfortably over patients' closed eyelids Firstly, this device reduces the viscosity of the oil (meibum) by delivering heat to the eyelids through a novel combination of several mechanisms. Secondly, it utilizes a novel method of resonant frequency stimulation which involves vibrating at a variety of frequencies to cause shear thinning to induce oil liquefaction and mobilization in the meibomian glands. Finally, neuromodulation activates the lacrimal functional unit to cause meibum to be expressed by the meibomian glands.

Preparations for U.S. FDA premarket submission of Eye Lipid Mobilizer by Eyedetec Medical are currently underway. When it is approved in the United States, Eye Lipid Mobilizer will be the first and only home-based treatment for dry eye disease which will be prescribed by the doctor. A clinical study that Eyedetec Medical carried out in the United States in February and March 2022 provided convincing evidence of the device's efficacy, and a human factors study that took place in March 2022 demonstrated that Eye Lipid Mobilizer is intuitive and simple for patients to learn and use. Eye Lipid Mobilizer has already received high industry recognition, including second place in the Winning Pitch Challenge presentations at Eyecelerator 2023, which took place on May 4 in San Diego and was held as part of ASCRS (American Society of Cataract and Refractive Surgery).

According to the Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, “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 branded eyepatches selling on Tmall, our lead innovative asset CsA Ophthalmic Gel under NDA (New Drug Application) review, and several other innovative asset candidates with different mechanisms of action. We will continue to explore partnership opportunities with both domestic and international pharmaceutical companies and achieve our goal to become a global leader in ophthalmology.”

According to TechSci Research, the agreement for commercialization of Eye Lipid Mobilizer benefits both Zhaoke Ophthalmology Limited and Eyedetec Medical to gain access to the drug candidate and to assess its potential for commercialization which will enhance their portfolio for the treatment of dry eye disease and can develop a brilliant revenue in the coming years. The Zhaoke Ophthalmology Limited  is targeting to develop the first-ever solution for dry eye disease which will be prescribed by doctors. Also, the development and launches of new medical devices remarkably demand dry eye disease treatment and meibomian gland dysfunction treatment among those who are suffering from these diseases. Launching this device can enhance the demand for the ocular disease treatment market and can create drastic changes in the market due to more accessible of this device to patients around the globe along with this can ensure that the treatments are safe and effective. It can increase the awareness of dry eye disease treatment by using this device and its potential benefits.  With the launch of the ELM, the device has created a novel class of ophthalmic solutions and enhanced the research and development activities among the competitors.