Arctic Vision announces exclusive licensing agreement with ActualEyes to develop andcommercialize cell therapy to potentially replace corneal endothelial keratoplasty in Greater Chinaand South Korea-Arctic Vision to partner with ActualEyes to introduce novel approach of using cultured corneal
endothelial cells to treat corneal endothelial dysfunction and potentially replace corneal
endothelial keratoplasty.
Under the terms of the agreement, the deal is worth up to more than USD 35 million, including
upfront, regulatory milestone payments, and tiered royalties.

Shanghai, CHINA and Kyoto, JAPAN, May 14, 2021 /PRNewswire/ -- Arctic Vision, a clinical stage
biotech company focused on innovative ophthalmology therapies for pan-ocular diseases, andActualEyes, a clinical stage Japanese biotech company committed to the research and developmentof cell therapy for corneal endothelial diseases, today jointly announced an exclusive licensing
agreement for Arctic Vision to develop and commercialize ActualEyes’ lead product candidate, AE-101,
for the treatment of corneal endothelial dysfunction in Greater China (mainland China, Hong Kong,Macau and Taiwan) and South Korea.
Under the terms of the agreement, ActualEyes may receive up to more than USD 35 million payments,
including upfront payment, future regulatory milestones, and tiered royalties on net sales.
Corneal endothelial dysfunction is the result of severe endothelium damage caused by different
pathologies, including Fuchs’ endothelial corneal dystrophy (FECD), pseudophakic bullous keratopathy,
trauma, glaucoma, and endothelial keratitis, etc. It is estimated that over one million patients sufferfrom corneal endothelial dysfunction in China, and in the most severe cases, the most effective
treatment is corneal keratoplasty (penetrating keratoplasty and endothelial keratoplasty). However,
due to a severe shortage of donor corneas, less than ten percent of these patients in China may receive
a keratoplasty. At the same time, keratoplasty may have associated problems, such as potential graft
failure, infection, implant drop and unpredictable refractive state. Moreover, the keratoplasty
operation itself is demanding and technically challenging for surgeons.
AE-101 is a novel cell-injection therapy developed using cultured human corneal endothelial cells(hCECs) combined with a Rho-associated kinase (ROCK) inhibitor. Studies i,ii have demonstrated thatthe injection of hCECs supplemented with a ROCK inhibitor has strong efficacy and safety profiles inpatients with corneal endothelial dysfunction. The ground-breaking clinical research findings
published in the New England Journal of Medicine and Ophthalmology led by ActualEyes’ scientificfounders, Dr. Noriko Koizumi and Dr. Naoki Okumura, have shown that AE-101 can effectively restore
corneal endothelial function as well as vision, with no major treatment-relevant adverse reactions for
up to 5-years post-operation, which represents a paradigm shift in corneal regenerative medicine.
Dr. Eddy (Hoi Ti) Wu, Founder and CEO, Board Director of Arctic Vision, commented, “We are excited
to enter into this partnership with ActualEyes to further develop AE-101, a potent cell-therapy solution
for the treatment of corneal endothelial dysfunction. China is a market with high prevalence of corneal
diseases as well as huge unmet clinical need due to the shortage of donor corneas. The market
potential is tremendous for more accessible therapies with greater safety and efficacy. The licensingof AE-101 represents not only a corporate milestone of incorporating the first cell therapy in ourpipeline, but also our commitment to an overall portfolio strategy aimed to discover and deliver
breakthrough therapies for patients in China and Asia.”
Iku Sugioka, President and Chief Executive Officer of ActualEyes, said, “We look forward tocollaborating with Arctic Vision to develop our lead clinical candidate AE-101. The potential benefitsof cell therapy are significant for patients suffering from vison impairment or loss caused by corneal
endothelial dysfunction. From our previous research, AE-101 has great potential to provide a lessinvasive and more effective therapeutic modality compared to conventional surgical therapies. With
the compelling track records of Arctic Vision’s management team in research and commercial fronts,
we are confident that this partnership is the start of a long-term relationship to bring our novel AE101 therapy to broader markets in Asia.”***
About ActualEyes
Founded based on the research of Professors Noriko Koizumi and Naoki Okumura at Doshisha
University in Kyoto, Japan, ActualEyes is a Japan-based clinical stage biotech company committed to
the research and development of both cell therapy and pharmacological treatments for corneal
endothelial dysfunction, including Fuchs endothelial corneal dystrophy (FECD) and bullous
keratopathy. For more information, please visit www.actualeyes.co.jp
About Arctic Vision
Arctic Vision is a China-based clinical stage specialty ophthalmology company with a leading portfolioof breakthrough technologies. The company’s vision is to address ophthalmology’s unmet needs
through innovative therapies in China, Asia and globally. Arctic Vision was established by top-tier life
sciences investors and is led by an elite team of ophthalmic industry veterans with substantial andcompelling China and global experiences in both R&D and the commercialization of eye care products.
For more information, please visit www.arcticvision.com.
Arctic Vision contact:
Chris Fang
Senior Director, Corporate Development
chrisfang@arcticvision.com
ActualEyes contact:
Naoto Matsuda
Director, Corporate Planningnaoto.matsuda@actualeyes.co.jp

Kinoshita, Shigeru & Koizumi, Noriko et al. (2018). Injection of Cultured Cells with a ROCK Inhibitor for Bullous
Keratopathy. The New England journal of medicine. 378. 995-1003. 10.1056/NEJMoa1712770.
ii
Numa, Kohsaku & Imai, Kojiro et al. (2020). Five-Year Follow-up of First Eleven Cases Undergoing Injection ofCultured Corneal Endothelial Cells for Corneal Endothelial Failure. Ophthalmology. 128.
10.1016/j.ophtha.2020.09.002.
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