Aurion Biotech recently announced that the company has launched its treatment for severe eye diseases in Japan.Bullous KeratopathyAurion Biotech's cell therapy Vyznova, its first market, becomes an alternative for corneal replacement using donor tissue.

According to the company headquartered in Seattle, Washington,Vyznova (neltependocel, formerly known as AURN001) is the world's first allogeneic cell therapy for the treatment of corneal endothelial disease.The therapy has received reimbursement approval in Japan and has been used to treat patients at Kyoto Prefectural University of Medicine (KPUM).

Aurion Biotech's mission is to restore vision to millions of patients through life-changing regenerative therapies. On September 25, the company announced the commercial launch of Vyznova® (generic name: neltependocel) in Japan for the treatment of bullous keratopathy.

Video: Aurion Cell Therapy Procedure

Bullous Keratopathy (formerly known as bullous keratitis) is a vision-threatening condition characterized by the formation and rupture of blisters (bullae) on the cornea, sometimes causing severe pain, with the death of corneal endothelial cells.This in turn leads to corneal opacity, with symptoms such as blurred vision, difficulty seeing at night, and discomfort when looking at bright lights. If not treated promptly, it may also lead to blindness.Generally, the high-risk groups for bullous keratopathy mainly include children, the elderly, etc.

Aurion Biotech, Inc. announced that despite the remarkable outcomes of corneal transplant surgeries, there remains a persistent shortage of corneal donors. One study revealed that for every 70 diseased eyes, only one corneal donor is available for transplantation. The company has developed a production method capable of generating up to 1,000 doses of Vyznova from the endothelial cells of a single donor's cornea.

When corneal transplantation is not possible, therapeutic contact lenses are sometimes used to relieve pain and improve vision, but the effects are limited.

Aurinia acquired the cell therapy technology that Vyznova relies on from KPUM and its original developer, Professor Shigeru Kinoshita, who will also be responsible for implementing the treatment program after its market launch.

"Aurion CEO Greg Kunst said, 'Our commercial launch in Japan is exciting for patients around the world suffering from corneal endothelial disease.'"

"After receiving regulatory and medical reimbursement approval in Japan earlier this year, we intend to work closely with corneal treatment specialists in medical institutions to adopt and promote their treatments for this debilitating eye disease, enabling patients to achieve better recovery."

Plans to introduce Vyznova to other global markets are already underway. Aurion Biotech, Inc. recently completed enrollment and dosing of 97 subjects in a Phase 1/2 clinical trial of cell therapy (called CLARA) in the United States and Canada. The trial focuses on treating corneal edema caused by corneal endothelial dysfunction. Results are expected to be announced in 2025.

In June, Aurion also received the coveted Breakthrough Therapy and Regenerative Medicine Advanced Therapy (RMAT) designations from the U.S. FDA for Vyznova, which could expedite the review of the therapy.

Source: Stem Cells and Exosomes

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