What ActualEyes does

ActualEyes Inc. (アクチュアライズ株式会社) is a Japanese clinical-stage biotechnology company founded on May 1, 2018, as an academic spin-off from Doshisha University by Professors Noriko Koizumi (CSO) and Naoki Okumura (Director, R&D Manager). Headquartered at the Doshisha University business incubator in Kyotanabe City, Kyoto, the company develops treatments for corneal endothelial disorders—principally bullous keratopathy and Fuchs endothelial corneal dystrophy (FECD)—conditions that together drive a substantial share of the global corneal transplantation burden and for which only 1 in 70 patients worldwide currently receive a transplant. The pipeline comprises a regenerative cell therapy AE101 (cultured human corneal endothelial cells with ROCK inhibitor-assisted injection) and pharmaceutical candidates AE001 (sirolimus ophthalmic solution) and AE002 (an undisclosed-mechanism FECD candidate).

The technology stack is built on 20+ years of Doshisha University research translated into exclusive inbound IP licenses: ROCK inhibitor-assisted corneal endothelial cell culture and injection transplantation (first-in-human clinical research conducted at Kyoto Prefectural University of Medicine since December 2013, with over 50 patients treated and 5-year follow-up data published), a cryopreserved ready-to-use cell formulation that can treat 50–80 patients from a single donor cornea, and sirolimus as a disease-modifying eye drop for FECD. Co-development with D. Western Therapeutics Institute (DWTI) covers AE101 in Japan; manufacturing is contracted to Japan Tissue Engineering (J-TEC). Licensing and co-development partners include Arctic Vision (AE101 exclusive license for Greater China and South Korea, total deal value over USD 35 million) and Santen Pharmaceutical (AE001 global co-development with Phase IIa PHANTOM study in the US since June 2022, plus planned sites in France and India).

The business model is licensing- and partnership-driven rather than direct-to-physician sales. Revenue mechanics (when realized) will consist of upfronts, development milestones, and tiered royalties from pharmaceutical partners; cumulative equity and grant funding totals approximately 1 billion yen across three rounds (Series A ~470M JPY in October 2019 with JST and Mitsubishi UFJ Capital among investors; Series B 330M JPY in June 2022 led by DWTI; Series C 850M JPY in November 2024 led by a domestic pharmaceutical company, ongoing toward ~1B JPY). Leadership transitioned in April 2025 with Yasushi Matsuoka appointed as President and CEO, bringing prior experience at Mitsubishi Tanabe Pharma and FUJIFILM to drive the company through commercialization.

Name

ActualEyes

Legal name

ActualEyes Inc.

Website

https://actualeyes.co.jp

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

11–50 employees

Short description

ActualEyes Inc. is a Japanese clinical-stage biotech founded in 2018 from Doshisha University, developing AE101 cultured corneal endothelial cell therapy and AE001 sirolimus eye drops to replace corneal transplantation. Products are partnered globally with Santen, Arctic Vision, and D. Western Therapeutics Institute.

Ownership category

akta.pro rank

Product category

Ophthalmic Therapeutics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

akta.pro primary industry

Ophthalmic Regeneration (cornea/retina) (HLAAAGAK)

akta.pro secondary industries

Ophthalmology Pharmaceuticals (HLAIAAAL), Ocular Drug Delivery Devices (Eye Droppers/Inserts) (HLAHAIAL), Cornea, External Disease & Refractive Surgery (LASIK/PRK) (HLAKAKAF)

Keywords

• Regenerative medicine
• Cell therapy products
• Ophthalmic pharmaceuticals
• Corneal endothelial therapy
• Biotech drug development

Headquarters

HQ city

Kyoto

HQ country

Japan

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Licensing and milestone payments from pharma partners: ActualEyes earns revenue through licensing deals with pharmaceutical companies. This includes upfront payments, pharmacitical milestones, and tiered royalties. Examples: Arctic Vision licensing for AE101 in Greater China and Korea (total deal value over $35M USD including upfront, milestones, and royalties); Santen joint development for AE001 (sirolimus) with milestone and royalty structure.
2. Government grants and non-dilutive funding: Funding from JST (Japan Science and Technology Agency) and other government-backed programs supporting academic-originated biotech ventures. JST participated in the Series A/first funding round as an investor.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

ActualEyes develops cell therapy and pharmaceutical treatments to replace corneal transplantation for corneal endothelial disorders. Its portfolio includes AE101, a cultured human corneal endothelial cell injection therapy, and AE001 (sirolimus ophthalmic solution) and AE002 drug candidates for Fuchs endothelial corneal dystrophy. Products are advanced through licensing and co-development partnerships with pharmaceutical companies rather than direct sales.

Product overview

ActualEyes is developing a dual-pronged portfolio of treatments for corneal endothelial diseases: (1) Pharmaceutical drug candidates AE001 and AE002 as eye drop treatments for Fuchs Endothelial Corneal Dystrophy, co-developed with Santen Pharmaceutical, and (2) AE101, a regenerative medicine cell product consisting of cultured human corneal endothelial cells administered via injection, for bullous keratopathy and corneal endothelial failure. The company aims to replace corneal transplantation with these innovative treatments.

Differentiator

Problem solved

Functional benefit

Brands

• AE001: Sirolimus ophthalmic solution for Fuchs endothelial corneal dystrophy treatment, developed in collaboration with Santen Pharmaceutical.
• AE002
• AE101

Products and services

• AE001 (Sirolimus Ophthalmic Solution) Sirolimus eye drops for the treatment of Fuchs Endothelial Corneal Dystrophy. Development code AE001, partnered with Santen Pharmaceutical (Santen code: STN1010904). Stops the death of corneal endothelial cells in Fuchs endothelial corneal dystrophy.
• AE002 Product candidate with a different mechanism of action than AE001, expected to prevent progression of Fuchs Endothelial Corneal Dystrophy. Currently preparing for clinical trials.
• AE101 Cultured human corneal endothelial cell product for treatment of corneal endothelial disorders and bullous keratopathy. Developed as a ready-to-use cryopreserved cell formulation. Mass culture system produces enough cells from a single donor cornea to treat 50-80 patients. Co-developed with D. Western Therapeutics Institute in Japan and licensed to Arctic Vision for Greater China and South Korea.

Quantifiable outcome

• 1 in 70 patients worldwide receive corneal transplants due to severe donor shortage
• +7 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Ten partnerships are on record, tiered core and minor.

• Prema Padmanabhan (Sankara Nethralaya)coreOthers · 13 June 2024World-renowned ophthalmologist and director at Sankara Nethralaya, one of India's largest eye specialty hospitals. Joins as advisor to leverage extensive experience in corneal disease treatment for accelerating ActualEyes' product development. Sankara Nethralaya has co-authored research papers with ActualEyes founders.
• Keith H. Baratz (Mayo Clinic)coreOthers · 14 May 2024Professor of Ophthalmology at Mayo Clinic joins as advisor. Baratz is a leading researcher on Fuchs dystrophy genetics (TCF4 gene trinucleotide repeat discovery) and corneal transplantation. Provides strategic guidance on Fuchs dystrophy drug development and corneal endothelial regeneration products.
• Japan Innovative Therapeutics (日本革新創薬)minorOEM/ Whitelabel/ Licensing Partner · 18 November 2022Received exclusive license for corneal endothelium therapeutic agents from Japan Innovative Therapeutics, which had received exclusive implementation rights from Doshisha University. This expanded the development pipeline for drug treatments targeting corneal endothelial disorders including Fuchs dystrophy and bullous keratopathy.
• Japan Tissue Engineering Co., Ltd. (J-TEC)coreTechnology or Integration · 8 August 2022Manufacturing agreement for corneal endothelial regenerative medicine product candidate AE101. J-TEC is a leading regenerative medicine company in Japan with multiple products already commercialized. Manufacturing at J-TEC ensures safety, efficacy, and stable production of the cell therapy product.
• Yuichi Hidaka (D. Western Therapeutics Institute)coreOthers · 3 August 2022Representative Director of DWTI appointed as outside director of ActualEyes as part of the Series B investment and joint development partnership. Brings drug development expertise from DWTI to ActualEyes' board.
• D. Western Therapeutics Institute (DWTI)coreStrategic or Co-development Partner · 30 June 2022Joint development agreement for corneal endothelial regenerative medicine product AE101 in Japan. DWTI also served as a lead investor in Series B funding (330 million yen) and appointed Yuichi Hidaka as outside director of ActualEyes. The partnership combines DWTI's drug development expertise with ActualEyes' cell therapy technology.
• Santen Pharmaceutical Co., Ltd.coreStrategic or Co-development Partner · 31 May 2022Joint development agreement for sirolimus ophthalmic solution (development code: AE001; Santen code: STN1010904) for Fuchs endothelial corneal dystrophy. Phase IIa/POC clinical trial (PHANTOM study) started in the US in June 2022, with plans in France and India. Santen handles global development and commercialization with ActualEyes holding co-development rights.
• Arctic VisioncoreOEM/ Whitelabel/ Licensing Partner · 14 May 2021Exclusive license agreement for AE101 in Greater China (Mainland China, Hong Kong, Macau, Taiwan) and South Korea. Total deal value over $35 million USD including upfront payment, pharmacitical milestones, and tiered royalties. Arctic Vision handles development, regulatory approval, and commercialization in the licensed territories.
• Doshisha University (Co-founders Koizumi & Okumura)coreStrategic or Co-development Partner · 1 May 2018Academic spin-off from Doshisha University. Co-founders Professors Noriko Koizumi (CSO) and Naoki Okumura (Director) continue their research at Doshisha University while serving as directors of ActualEyes. The company holds exclusive licenses from Doshisha University for key technologies including sirolimus for Fuchs dystrophy and corneal endothelial cell culture methods.
• Kyoto Prefectural University of MedicinecoreStrategic or Co-development Partner · 1 December 2013Technology transfer of corneal endothelial cell culture and injection therapy for first-in-human clinical research. The world's first cell injection therapy trial for corneal endothelial disease began here in December 2013. Over 50 patients successfully treated, establishing safety and efficacy data critical for AE101 development.

Scale indicators5 records

Recent moves6 records

Expansion highlights7 records

Direct peers

• Cellusion: Japan-based regenerative medicine company developing iPSC-derived corneal endothelial cells for bullous keratopathy. Closest Japanese competitor to AE101 with overlapping mechanism and patient population.
• Aurion Biotech: US clinical-stage biotech developing AURN001, a corneal endothelial cell therapy for corneal endothelial disease. Most direct global competitor to ActualEyes' AE101 with similar cell-therapy mechanism and target indication.
• EyeYon Medical: Israel-based company developing cell-based and synthetic solutions for corneal endothelial failure (EndoArt, Corneal Endothelial Cell Implant). Targets the same bullous keratopathy indication as AE101 via complementary approach.

Broad incumbents

• Alcon: Global ophthalmic medical device and pharmaceutical leader. Comparable as a broad incumbent that controls much of the surgical and pharmaceutical ecosystem in which ActualEyes' products would ultimately be administered and reimbursed.
• Bausch + Lomb: Global ophthalmic pharma and device company with a portfolio spanning pharmaceuticals, surgical, and vision care. Comparable as a broad incumbent competing for share of voice across ophthalmic pharmaceutical channels.
• Santen Pharmaceutical: Japan-headquartered global ophthalmic specialty pharma and ActualEyes' co-development partner on AE001. Comparable because of its dominant position in Japanese ophthalmology and overlapping focus on corneal endothelial disease therapeutics.

Emerging players

• CorNeat Vision: Israel-based clinical-stage company developing synthetic and regenerative solutions for corneal disease. Comparable as an emerging player in the corneal regeneration space adjacent to ActualEyes' cell-therapy platform.
• jCyte: US clinical-stage cell therapy company developing allogeneic cell therapies for retinal diseases. Comparable as an emerging ophthalmic cell-therapy peer that shares regulatory pathway, manufacturing complexity, and clinical-trial execution model with AE101.

Regional players

• Senju Pharmaceutical: Japan-based ophthalmic pharmaceutical company with board representation at ActualEyes. Comparable as a regional specialty ophthalmic player and incumbent in the Japanese corneal/ocular surface therapeutic market.
• Rohto Pharmaceutical: Japanese pharmaceutical company with a significant ophthalmology and eye-care franchise. Comparable as a regional incumbent with adjacent product categories in dry eye and ocular surface therapeutics.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about ActualEyes