June 30, 2022
Conclusion of Joint Development Agreement forCorneal Endothelial Regenerative Medicine Product AE-101, andSeries B Funding through Third-Party Allocation of Shares
ActualEyes Inc. (President and CEO Iku Sugioka; headquartered in Kyoto Prefecture;
hereinafter, “ActualEyes”) announces the conclusion of a joint development agreement inJapan with D. Western Therapeutics Institute, Inc. (President and CEO Yuichi Hidaka;
headquartered in Nagoya, Aichi Prefecture; hereinafter, “DWTI”) regarding ActualEyes’ leadproduct candidate AE-101, and a Series B funding round through third-party allocation ofshares.
AE-101 is a novel cell injection therapy developed by ActualEyes for the indication of bullous
keratopathy, using cultured human corneal endothelial cells (hCECs) combined with a Rhoassociated kinase (ROCK) inhibitor. ActualEyes and DWTI have resolved to proceed withjoint development of AE-101 with a view to benefiting patients as soon as possible. Under
the terms of the agreement, ActualEyes and DWTI will undertake joint development of AE101 in Japan. DWTI will fund the development of AE-101 and therefore will be entitled to aportion of all income generated by AE-101 as a development partner. The two companies
plan to proceed with clinical trials in Japan, and file for manufacturing and marketing
authorization at the earliest possible juncture.
In addition, on this day ActualEyes conducted a Series B third-party allocation of new shares,
raising a total of 330 million yen. The issue of new shares was underwritten by two companies,
one being ActualEyes’ development partner, DWTI. This round of financing is a follow-up tothe third-party allocation of new shares announced in October 2019. Following this Series B
financing, plans call for additional fund-raising in the coming months.
ActualEyes is a bioventure with roots in Doshisha University, focused on development ofnovel ophthalmological drugs including regenerative therapies for corneal endothelial
dysfunction and pharmacological treatments for Fuchs’ endothelial corneal dystrophy(FECD). The corneal endothelium is essential for keeping the cornea transparent, butdamage can cause the cornea to become cloudy, leading to severely impaired vision. The
standard therapy at present is corneal keratoplasty (an organ transplant). However, due to aglobal shortage of donor corneas, a more effective mode of treatment is necessary. With thefunds raised this time, ActualEyes will pursue research and development into AE-101 inparticular, with a view to commercializing regenerative medicines for the treatment of corneal
endothelial dysfunction at an early stage and with stable quality. FECD is a corneal
endothelial disease said to affect approximately 4% of people aged 40 or over in the UnitedStates, and as the condition accounts for about 40% (the highest ratio) of corneal transplant
surgeries, there is great need for a new treatment option. ActualEyes is also engaged indevelopment of an eye drop targeting FECD.
About ActualEyes Inc. (headquartered in Kyotanabe, Kyoto Prefecture)
Founded based on the research of Noriko Koizumi, M.D., Ph.D. and Naoki Okumura, M.D.,
Ph.D. (ophthalmologists and professors at Doshisha University’s Department of BiomedicalEngineering), ActualEyes is engaged in research and development into both regenerative
medicines and pharmacological treatments for FECD and other forms of corneal endothelial
dysfunction.

For

moreinformation,pleasevisit

ActualEyes’

website(www.actualeyes.co.jp/en/).
About D. Western Therapeutics Research Institute, Inc. (headquartered in Nagoya, AichiPrefecture)
Based on the vision of bringing “Innovative New Drugs to the World from Japan,” D. WesternTherapeutics Institute (DWTI) is a bioventure aiming to deliver more effective new drugs assoon as possible to the patients who need them. DWTI’s strength is in the discovery of kinase
inhibitors, some of which already have been brought to market. Currently, DWTI is focusing
on the field of ophthalmology, to aid in selection of the optimal treatment for each patient. For
more information, please visit DWTI’s website (www.dwti.co.jp/english/).
Inquiries
ActualEyes Inc.
Masahiko Kato, Senior Director, General Administration
E-mail: masahiko.kato@actualeyes.co.jp