Aurion launches eye disease cell therapy in its first market

Aurion Biotech has launched its cell therapy Vyznova for serious eye disorder bullous keratopathy in Japan, its debut market, becoming an alternative to corneal replacement using donor tissue.

Vyznova (neltependocel, formerly AURN001) is the world's first allogeneic cell therapy for corneal endothelial disease, according to the Seattle, Washington-based company. It already has reimbursement approval in Japan and has been used to treat patients at Kyoto Prefecture University of Medicine (KPUM).

Bullous keratopathy is a sight-threatening condition in which blisters (bullae) form on the cornea and rupture, sometimes causing severe pain, and corneal endothelial cells die off. That in turn leads to clouding of the cornea and symptoms including blurred vision, difficulties seeing at night, discomfort when looking at bright lights, and potentially blindness if left untreated.

While transplants are effective, there is a chronic shortage of donor corneas, according to Aurion, citing one study showing that, for every 70 diseased eyes, there is only one donor cornea available for transplant. The company has developed a manufacturing process that can produce up to 1,000 doses of Vyznova from the corneal endothelial cells of a single donor.

When corneal transplants aren't possible, therapeutic contact lenses are sometimes used to provide pain relief and improve sight, but provide limited benefit.

Aurinia acquired the cell therapy technology underpinning Vyznova from KPUM and its original developer Professor Shigeru Kinoshita, who carried out the post-launch treatment procedures.

"Our commercial launch in Japan is exciting for patients around the world who suffer from corneal endothelial diseases," said Greg Kunst, Aurion's chief executive.

"After having received regulatory and reimbursement approval earlier this year in Japan, we intend to work closely with corneal specialists here, to adopt and disseminate their best practices for treating patients with this debilitating disease."

Plans are already underway to bring Vyznova to other world markets, and Aurion recently completed enrolment and dosing of 97 subjects in a phase 1/2 clinical trial of the cell therapy in the US and Canada, called CLARA, which is focusing on corneal oedema secondary to corneal endothelial dysfunction. Results are expected in 2025.

In June, Aurion also secured coveted breakthrough therapy and regenerative medicine advanced therapy (RMAT) designations from the US FDA for Vyznova, which could lead to an expedited review of the treatment.