- Arctic Vison will lead innovative transformative therapies for myopia and presbyopia, launching development and commercialization in China and South Korea
-Eyenovia, Inc. shall be entitled to receive aggregate payments of up to $45.75 million, including an upfront payment, development and commercialization milestone payments, and subsequent research and development expenses
Shanghai, China and New York, USA, August 11, 2020 – Arctic Vision and Eyenovia, Inc. (NASDAQ: EYEN) jointly announced on August 11 (U.S. time) the signing of an exclusive license agreement to advance the clinical development and commercialization of Eyenovia’s two flagship innovative ophthalmic therapies—MicroPine for the treatment of progressive myopia and MicroLine for the treatment of presbyopia (also known as farsightedness due to aging)—in Greater China (Mainland China, Hong Kong, Macau, and Taiwan) and South Korea. Arctic Vision (hereinafter referred to as “Arctic Vision”) is a clinical-stage biotechnology company dedicated to developing and commercializing innovative ophthalmic therapies in China and across Asia. Eyenovia, Inc. is a clinical-stage ophthalmic biopharmaceutical company developing a pipeline of products based on its MAP™ (Microdose Array Print) technology platform.Under the terms of the agreement, Eyenovia, Inc. is eligible to receive total potential payments of up to $45.75 million, including an upfront payment and additional payments tied to various clinical development milestones, such as the initiation of regulatory filings and approvals by Arctic Vison in China and South Korea, as well as reimbursements for related research and development expenses.
Dr. Eddy Wu, Founder and CEO of Arctic Vison, commented on the collaboration, stating, “Eyenovia, Inc. is a pioneer in the treatment of myopia and presbyopia using its novel MAP™ (MicroArray Precision) ‘micro-matrix drug film’ technology. We are fully committed to accelerating the development of MicroPine and MicroLine in Greater China and South Korea. In certain parts of Asia, the prevalence of childhood myopia has reached as high as 50%, and this figure continues to rise. Meanwhile, an increasing number of individuals aged 40 and above are gradually affected by age-related presbyopia, which currently can only be treated with medical devices or surgical interventions. Therefore, we are confident that MicroPine and MicroLine hold significant potential in addressing patient needs unmet by traditional eye drops. Furthermore, this collaboration plays a vital complementary role in expanding Arctic Vison’s innovative product pipeline. We believe that through this partnership, we will lead the Chinese ophthalmic treatment market toward an innovative future.”
Dr. Sean Ianchulev, CEO and Chief Medical Officer of Eyenovia, stated, “This licensing agreement with Arctic Vison will further help us expand our commercial footprint into some of the largest global markets for progressive myopia. As our therapeutic solutions continue to gain clinical validation, the financial support from this collaboration will also be used to advance the development of other products, including the planned U.S. launch of MicroStat next year, as well as the clinical R&D of our late-stage pipeline assets, such as MicroPine for the treatment of progressive myopia and MicroLine for improving near vision.”
On MicroPine for the Treatment of Myopia
MicroPine (atropine ophthalmic solution) is indicated for progressive myopia, a posterior segment ocular disorder commonly known as nearsightedness. It is estimated that nearly 5 million children in the United States suffer from progressive myopia, characterized by abnormal regulation of scleral axial elongation leading to increased myopic refractive error. In some cases, this may result in serious pathological changes, such as retinal atrophy, macular scleral staphyloma, retinal detachment, and visual impairment. MicroPine was developed with consideration for comfort and ease of use in pediatric patients, employing microdose delivery to minimize systemic and ocular drug exposure. Recent therapeutic evidence assessments and reviews by the American Academy of Ophthalmology indicate that low-dose atropine provides Level 1 (highest) evidence of efficacy for the treatment of progressive myopia (Ophthalmology 2017; 124: 1857-1866; Ophthalmology 2016; 123(2): 391-399). For additional clinical studies, please refer to the following feasibility and dose-exploration studies of atropine: ATOM2; ATOM 23; LAMP (all conducted by independent collaborative groups).
On MicroLine for the Treatment of Presbyopia
MicroLine is a pharmacological treatment for presbyopia. Presbyopia cannot be prevented; it results from the age-related hardening of the crystalline lens within the eye, leading to a gradual loss of the eye’s ability to focus on near objects. This condition affects nearly 113 million people in the United States. Current treatment options are typically based on medical devices, such as reading glasses and contact lenses. The efficacy of pilocarpine ophthalmic solution in improving near vision through miosis is well established, with its mechanism of action relying on the pinhole effect to create an increased depth of focus. Eyenovia, Inc. believes that administering pilocarpine using its high-precision MAP™ technology can deliver meaningful improvements in near vision while enhancing tolerability and usability.
Optejet® and MicroRx for Ophthalmic Treatment
Eyenovia, Inc.’s Optejet® microdose formulation and delivery platform for ophthalmic therapy utilizes high-precision piezoelectric printing technology to deliver a dose of 6–8 μL, which is consistent with the tear film capacity of the human eye. We are confident that the volume of ophthalmic solution delivered via Optejet® is only one-quarter of that administered by conventional eye drops, thereby reducing overtreatment and exposure to drugs or preservatives. Eyenovia’s patented microfluidic jetting technology is specifically designed for rapid and gentle ocular surface delivery, administering the solution to the ocular surface in approximately 80 milliseconds without being affected by the blink reflex. The successful application of Optejet® has been demonstrated; in various clinical settings, the successful administration rate exceeded 85% after basic training, compared to only 40%–50% for traditional eye drops. Furthermore, its smart electronic devices and mobile e-health technologies can track and improve patient adherence⁴.
1. https://www.aaojournal.org/article/S0161-6420(17)31675-5/pdf
2. Chua WH, Balakrishnan V, Chan YH, et al. Atropine for the treatment of childhood myopia. Ophthalmology. 2006;113(12):2285-2291. doi:10.1016/j.ophtha.2006.05.062
3. Chia A, Chua WH, Cheung YB, et al. Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology. 2012;119(2):347-354. doi:10.1016/j.ophtha.2011.07.031
4. Rudnicka, A. R., Kapetanakis, V. V.,Wathern, A. K., Logan, N. S., Gilmartin, B., Whincup, P. H., Owen, C. G. Globalvariations and time trends in the prevalence of childhood myopia, a systematicreview and quantitative meta-analysis: Implications for aetiology and earlyprevention. British Journal of Ophthalmology, 100(7), 882-890.doi:10.1136/bjophthalmol-2015-307724
Arctic Vision is a China-based, clinical-stage ophthalmic biotechnology company with a leading portfolio of breakthrough therapeutic products. The company’s vision is to address unmet medical needs in the field of ophthalmic diseases by providing innovative therapies in China, Asia, and globally. Founded with support from top-tier life science investors, Arctic Vision is led and managed by an elite industry team with extensive and distinguished experience in the research, development, and commercialization of ophthalmic products both in China and worldwide. For more information, please visit www.arcticvision.com.
Eyenovia, Inc. (NASDAQ: EYEN) is a clinical-stage ophthalmic biopharmaceutical company dedicated to developing a product pipeline based on its MAP™ (Microdose Array Printer) platform. Eyenovia’s current R&D pipeline focuses on the late-stage clinical development of microdose therapeutics for presbyopia, myopia progression, and pupil dilation. For more information, please visit www.eyenovia.com.
Forward-Looking Statements
Except for historical information, all statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, expressions of Arctic Vison’s intentions, beliefs, expectations, strategies, forecasts, or any other statements related to our future activities or other future events or conditions, including estimated market opportunities in China and our candidate products. These statements are based on current expectations, estimates, and projections regarding our business, partially based on management’s assumptions, and are not guarantees of future performance. They involve risks, uncertainties, and assumptions that are difficult to predict. Any forward-looking statement speaks only as of the date of this press release, and we undertake no obligation to update any forward-looking statements.
For more information:
Arctic Vision Contact:
Chris Fang
Senior Director, Corporate Development
chrisfang@arcticvision.com / communications@arcticvision.com
