Our Product Pipeline

Advancing Cell Therapies to Help Restore Vision

Aurion Biotech is developing first-in-class cell therapies designed to address the global need for scalable, practical, and effective treatments for ophthalmic diseases. Our programs are built on more than a decade of clinical and scientific innovation, with a focus on patient access, physician usability, and long-term impact.

Corneal Endothelial Cell Therapy (CECT)

Aurion Biotech is pioneering Corneal Endothelial Cell Therapy (CECT), a next-generation therapeutic approach that replaces a dysfunctional endothelial layer using cultivated, natural, unmodified human donor endothelial cells. Unlike graft-based keratoplasty, CECT restores a natural corneal endothelium.

This approach is being developed to:

Provide minimally invasive care to patients
Optimize utilization of precious donated tissue
Streamline treatment delivery
Support a potentially shorter and more comfortable recovery experience
Expand global availability to advanced care

From a single donor, our process is designated to enable treatment of up to 1,000 recipients, addressing global tissue limitations and supporting broader availability of therapy.

Pipeline

Product / Product Candidate

Current Stage

Vyznova

Approval 1H 2023
Commercially available in Japan

First-generation corneal endothelial cell therapy approved by Japan’s PMDA for patients with bullous keratopathy. Built on a decade of pioneering clinical research in endothelial cell injection.

AURN001 BTD/RMAT

AURN001 is a first-in-class combination therapy consisting of natural, unmodified donor endothelial cells (neltependocel) delivered with a rho-kinase inhibitor (Y-27632). It is designed to regenerate corneal clarity by repopulating the posterior cornea with functional donor cells, offering a biologic alternative to graft-based keratoplasty.

Cryopreserved AURN001

A program evaluating a cryopreserved formulation of Aurion’s endothelial cell therapy in clinical study. This formulation is being developed to support broader distribution and treatment accessibility.

U.S. FDA Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation granted under AURN001

How Corneal Endothelial Cell Therapy Works

AURN001 is designed to restore corneal clarity by delivering natural corneal endothelial cells that regenerate the cornea’s native structure. In order to maximize patient safety, the cells delivered to patients are natural human corneal endothelial cells obtained from transplant-grade donated corneas selected under stringent quality control and tested to ensure absence of pathogens. AURN001’s cells do not contain any synthetic materials, nanoparticles or artificial bioengineered scaffolds.

The cells are not obtained by artificial reprogramming of cells that are foreign to the eye. In order to optimize efficacy of the cell therapy, at the time of surgery, the cells are delivered together with a medicine called a rho-kinase inhibitor. The rho-kinase inhibitor accelerates cell attachment, optimizes cell survival during surgery and activates the ability of the cells to reform a healthy corneal endothelium. The rho-kinase inhibitor is readily eliminated by the patient’s body within hours of serving its supportive function.

In long-term follow-up studies lasting up to 10 years after patients have received the cell therapy, no rejections have been observed and corneal clarity is retained.