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Scientific Publications and Educational Resources on Endothelial Cell Therapy

Peer Reviewed
Publications

Explore peer-reviewed research, clinical findings, and global perspectives on corneal endothelial disease and cell-based therapeutic approaches. These publications provide foundational insights into the science informing Aurion Biotech’s work.

Publications provided on this site are intended for scientific exchange for US healthcare providers. These publications appear in independent peer-reviewed journals and include information about the investigational agents and/or unapproved uses. Some authors have financial relationships with Aurion; see each publication’s disclosures. AURN001 is investigational and not FDA approved. Links to the publications may redirect to third-party websites and require a subscription to access the full text.

JAMA Ophthalmology
2026
Source: Feng Y, Lin CC, Rose-Nussbaumer J. The Rise of Cultured Human Corneal Endothelial Cell Therapy. JAMA Ophthalmol. 2026;144(5):478-479. doi:10.1001/jamaophthalmol.2026.0919.
American Journal of Ophthalmology Case Reports
2026
Source: Kataoka Y, et al. Long-term outcome of cultured corneal endothelial cell transplantation with descemetorhexis: A 10-year follow-up study. Am J Ophthalmol Case Rep. 2026;41:102489. doi:10.1016/j.ajoc.2025.102489.
Japanese Journal of Ophthalmology
2026
Source: Yamamoto Y, et al. Quality of life after cultured corneal endothelial cell transplant in patients with bullous keratopathy. Jpn J Ophthalmol. 2026;70(2):254-259. doi:10.1007/s10384-025-01280-6.
Ophthalmology
2025
Source: Kinoshita S, et al. Long-term Corneal Rejuvenation after Transplantation of Cultured Human Corneal Endothelial Cells. Ophthalmology. 2025;132(10):1105-1113. doi:10.1016/j.ophtha.2025.05.020.
Cornea
2025
Source: Holland EJ, et al. ESCALÓN: A Prospective Randomized Trial of Corneal Endothelial Cell Therapy in Subjects With Corneal Edema. Cornea. 2025;44(12):1497-1507. doi:10.1097/ICO.0000000000003844.
Japanese Journal of Ophthalmology
2024
Source: Ueno M, et al. Comprehensive combined analysis of physician-initiated phase II and III clinical trials on a cultured human corneal endothelial cell product for treating bullous keratopathy. Jpn J Ophthalmol. 2024;68(6):660-668. doi:10.1007/s10384-024-01123-w.
American Journal of Ophthalmology
2022
Source: Ueno M, et al. Superiority of Mature Differentiated Cultured Human Corneal Endothelial Cell Injection Therapy for Corneal Endothelial Failure. Am J Ophthalmol. 2022;237:267-277. doi:10.1016/j.ajo.2021.11.012.
Ophthalmology
2021
Source: Numa K, et al. Five-Year Follow-up of First 11 Patients Undergoing Injection of Cultured Corneal Endothelial Cells for Corneal Endothelial Failure. Ophthalmology. 2021;128(4):504-514. doi:10.1016/j.ophtha.2020.09.002.
New England Journal of Medicine
2018
Source: Kinoshita S, et al. Injection of Cultured Cells with a ROCK Inhibitor for Bullous Keratopathy. N Engl J Med. 2018;378(11):995-1003. doi:10.1056/NEJMoa1712770.
Ophthalmology
2026
Source: Kataoka Y, et al. Endothelial Cell Therapy for Post-Keratoplasty Corneal Endothelial Failure. Ophthalmology. Published online August 11, 2026. doi:10.1016/j.ophtha.2026.08.007.
JAMA Ophthalmology
2026
Source: Ogino R, et al. Cultured Human Corneal Endothelial Cell Injection for Endothelial Graft Failure After DSAEK. JAMA Ophthalmol. 2026;144(5):474-478. doi:10.1001/jamaophthalmol.2026.0812.
American Journal of Ophthalmology
2026
Source: Ogino R, et al. Cultured Human Corneal Endothelial Cell Injection Therapy in Phakic Eyes with Bullous Keratopathy. Am J Ophthalmol. Published online July 24, 2026. doi:10.1016/j.ajo.2026.07.038.
Cornea Open
2026
Source: Kobayashi A, et al. Longitudinal Anterior Segment Optical Coherence Tomography Imaging Findings After Cultured Human Corneal Endothelial Cell Injection Therapy (Vyznova) for Bullous Keratopathy: Twelve-Month Outcomes in Uncomplicated and Complicated Cases. Cornea Open. 2026;5(2). doi:10.1097/COA.0000000000000093.
Cornea
2026
Source: Ogino R, et al. Cultured Human Corneal Endothelial Cell Injection (Vyznova) in Eyes with Extremely Low Intraocular Pressure After Glaucoma Surgery: Case Reports. Cornea. Published online March 6, 2026. doi:10.1097/ICO.0000000000004145.
Cornea
2026
Source: Kobayashi A, et al. A Modified Long Corneal Tunnel Technique for Intracameral Injection in Cultured Human Corneal Endothelial Cell Therapy (Vyznova): A Preliminary Technical Report. Cornea. 2026;45(6):793-798. doi:10.1097/ICO.0000000000004110.
Cornea
2026
Source: Kobayashi A, et al. The “Polish Sign”: A Novel Intraoperative Visual Indicator During Descemet Membrane Polishing in Cultured Human Corneal Endothelial Cell Injection Therapy. Cornea. 2026;45(5):667-671. doi:10.1097/ICO.0000000000004092.
Cornea
2026
Source: Kobayashi A, et al. Early Clinical Outcomes of Cultured Human Corneal Endothelial Cell Injection (Vyznova) for Bullous Keratopathy: Initial Clinical Experience. Cornea. 2026;45(6):775-784. doi:10.1097/ICO.0000000000003984.
JAMA Ophthalmology
2024
Source: Tomioka Y, et al. Guttae Morphology After Cultured Corneal Endothelial Cell Transplant in Fuchs Endothelial Corneal Dystrophy. JAMA Ophthalmol. 2024;142(9):818-826. doi:10.1001/jamaophthalmol.2024.2718.
Scientific Reports
2022
Source: Toda M, et al. Quiescent innate and adaptive immune responses maintain the long-term integrity of corneal endothelium reconstituted through allogeneic cell injection therapy. Sci Rep. 2022;12(1):18072. doi:10.1038/s41598-022-22522-4.
Nature Biomedical Engineering
2019
Source: Yamamoto A, et al. A physical biomarker of the quality of cultured corneal endothelial cells and of the long-term prognosis of corneal restoration in patients. Nat Biomed Eng. 2019;3(12):953-960. doi:10.1038/s41551-019-0429-9.
Investigative Ophthalmology & Visual Science
2017
Source: Toda M, et al. Production of Homogeneous Cultured Human Corneal Endothelial Cells Indispensable for Innovative Cell Therapy. Invest Ophthalmol Vis Sci. 2017;58(4):2011-2020. doi:10.1167/iovs.16-20703.
Scientific Reports
2016
Source: Okumura N, et al. Rho kinase inhibitor enables cell-based therapy for corneal endothelial dysfunction. Sci Rep. 2016;6:26113. doi:10.1038/srep26113.
American Journal of Pathology
2012
Source: Okumura N, et al. ROCK inhibitor converts corneal endothelial cells into a phenotype capable of regenerating in vivo endothelial tissue. Am J Pathol. 2012;181(1):268-277. doi:10.1016/j.ajpath.2012.03.033.

Frequently Asked Questions

Find answers to common questions about corneal endothelial disease, current treatment options, and Aurion Biotech’s ongoing clinical development efforts.
The corneal endothelium is composed of a single layer of cells lining the posterior surface of the cornea. These cells regulate fluid balance to maintain corneal clarity, which is essential for vision. Because endothelial cells do not regenerate, their loss leads to swelling, clouding, and progressive visual decline.
Endothelial dysfunction occurs when endothelial cells degrade or are lost due to conditions such as Fuchs dystrophy, congenital dystrophies, age-related decline, or surgical trauma. As the cornea becomes edematous, patients may experience blurred vision, glare, reduced contrast, discomfort, or significant pain.

Early symptoms may be managed with topical therapies to reduce swelling.
More advanced disease typically requires corneal transplantation, including:

  • PK (Penetrating Keratoplasty) – full-thickness transplant
  • DSAEK / DMEK (Endothelial Keratoplasty) – selective replacement of the posterior cornea and endothelial layer

While effective, these procedures depend on donor tissue and specialized surgical expertise.

Vyznova was originally invented and first clinically developed in Japan. Aurion Biotech later acquired the rights to the therapy after substantial research and clinical experience had already been established through the pioneering work of Professor Shigeru Kinoshita and colleagues. This early development enabled regulatory approval in Japan and provided the foundation for Aurion’s subsequent clinical development programs in the United States and other regions.

Vyznova, Aurion’s corneal endothelial cell therapy is approved in Japan for the treatment of bullous keratopathy and has been commercially available in Japan since late 2024. In the US, AURN001 is being evaluated in the ongoing Phase 3 ASTRA clinical trial. AURN001 remains investigational and has not been approved by the FDA.

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