Announcement of Application for Manufacturing and Marketing Approval for Cultured
Autologous Corneal Epithelium (Development name: EYE-01M)- First application for a regenerative medical product in the field of ophthalmology in Japan March 20, 2019Japan Tissue Engineering Co., Ltd.
Fujifilm subsidiary Japan Tissue Engineering Co., Ltd. (J-TEC; head officein Gamagori, Aichi Prefecture; President: Kenichiro Hata) has filed an
application with the Ministry of Health, Labour and Welfare for manufacturingand marketing approval of cultured autologous corneal epithelium(development name: EYE-01M) for the treatment of corneal epithelial stem
cell deficiency*.
This application, made for a custom development project commissioned byophthalmic medical device maker Nidek Co., Ltd. (Gamagori, Aichi
Prefecture, President: Motoki Ozawa), is the first application for marketing
approval for a regenerative medical product in the ophthalmology field inJapan.
EYE-01M“EYE-01M” is cultured in sheets after corneal epithelial cells are harvested
from the limbus of the patient’s own corneal tissue and is then transplanted back to the patient in order toreconstruct the corneal epithelium and thereby improve visual acuity and other clinical symptoms (eyepain, feeling of a foreign body, lacrimation, feeling of dryness, etc.).
Under commission to develop “EYE-01M” by Nidek, J-TEC introduced technology for culturing corneal
cells from Professor Graziella Pellegrini and Professor Michele De Luca of the University of Modena andReggio Emilia in Italy and from Professor Koji Nishida (Ophthalmology) of Graduate School ofMedicine/Faculty of Medicine, Osaka University, and has been conducting a clinical trial since October
2014.
J-TEC is presently drawing upon the knowhow that it accumulated and the systems it established in thedevelopment of Japan’s first regenerative medical product, autologous cultured epidermis “JACE”, to pourits energies into the custom development and manufacturing business for regenerative medicine. The goal
is to provide one-stop and seamless support, not only the development of its own products, but also forContract Development and Manufacturing Organization (CDMO) projects that develop investigational
products and engage in commercial production, as well as Contract Research Organization (CRO)projects that engage in pharmaceutical consulting and conduct clinical trials, from the earliest phase ofregenerative medical product development through to the post-marketing stage. The application for
manufacturing and marketing approval for “EYE-01M” is part of a contract development projectcommissioned from Nidek. According to the contract, marketing of “EYE-01M” will be performed by Nidek.
While accelerating the development of its own regenerative medical products, J-TEC aims to contributeto improving patient’s quality of life (QOL) by promoting the practical application of regenerative medicine
through custom development of regenerative medical products that supports clinical research, clinicalstudies, and manufacture.

* Corneal epithelial stem cell deficiency
A condition that occurs when the corneal epithelial stem cells that are present in the limbus, which is theboundary between the conjunctiva and cornea, are lost owing to hereditary or external factors.

Japan Tissue Engineering Co., Ltd. 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan

URL: http://www.jpte.co.jp

(Reference Information)
The corneal epithelium is located at the outermost layer of the eye and its source is the corneal
epithelial stem cells that are present in the limbus, which is the boundary between the conjunctiva andcornea. When corneal epithelial stem cells are lost, a condition known as corneal epithelial stem cell
deficiency occurs, causing the cornea to become cloudy and visual acuity to decline. The causes ofcorneal epithelial stem cell deficiency may be hereditary, such as aniridia or sclerocornea; external, suchas alkaline trauma or burns; endogenous, such as Stevens Johnson syndrome or ocular pemphigoid; oridiopathic.

Conjunctiva

Bowmanmembrane

Descemet
membraneLens

CorneaVitreous bodyStroma
Limbus: At boundary between
conjunctiva and cornea, it is thelocus of corneal epithelial stem cells.

Endothelium

CorneaEpithelium: The outermost layer of the cornea, itconsists of corneal epithelial cells.

For inquiries on information on this press release, contact:
Japan Tissue Engineering Co., Ltd.
Corporate Planning Department, Corporate Management Division
TEL :+81-533-66-2020