Aurion Biotech Launches Vyznova in Japan, the First Cell Therapy for Corneal Endothelial Disease
Aurion Biotech announced the commercial launch of Vyznova (neltependocel) in Japan. Vyznova is the first approved cell therapy for the treatment of the corneal endothelial disease, bullous keratopathy. The therapy has received both regulatory and reimbursement approval in Japan, Aurion announced.
The inaugural cell therapy procedures using Vyznova were conducted by Professor Shigeru Kinoshita, MD, PhD, at Kyoto Prefecture University of Medicine (KPUM). Professor Kinoshita is a pioneer in the development of corneal endothelial cell therapy and created the process for propagating these cells in vitro. Aurion Biotech acquired this technology from Kinoshita and KPUM several years ago and has since scaled it for commercial production, enabling the manufacture of allogeneic human corneal endothelial cells, which are the active component of Vyznova.
“After more than 25 years of research, the benefits of our work are finally reaching patients,” Professor Kinoshita said in a company news release. “I am deeply grateful to my colleagues, mentors, and KPUM for their collaboration, and most importantly, to my patients, who have trusted us to develop this breakthrough regenerative medicine.”
Bullous keratopathy is a painful condition that affects the cornea's endothelial cells, causing fluid buildup in the form of blisters. The disease leads to clouding of the cornea, progressive vision loss, and eventually blindness if untreated. Since corneal endothelial cells do not regenerate naturally, treatment options have been limited to corneal transplantation, a procedure reliant on donor tissue. However, the global shortage of donor corneas has left many patients untreated; for every 70 diseased eyes, only one donor cornea is available .
Aurion Biotech’s manufacturing process addresses this shortfall by generating up to 1,000 doses of Vyznova from a single donor’s corneal endothelial cells, offering a transformative solution for patients with corneal endothelial disease.
“Our launch in Japan is an exciting milestone for patients suffering from corneal endothelial diseases worldwide,” said Greg Kunst, CEO of Aurion Biotech. “Following our regulatory and reimbursement approvals earlier this year, we’re eager to work with corneal specialists in Japan to ensure Vyznova becomes the gold standard for treating this devastating disease.”
In addition to the launch in Japan, Aurion Biotech said it has made progress in the U.S. and Canada, having completed enrollment of 97 subjects in its phase 1/2 clinical trial. The FDA has also granted both Breakthrough Therapy and Regenerative Medicines Advanced Therapy (RMAT) designations to Vyznova.