Aurion Biotech announced Vyznova (neltependocel) – which it says is the first treatment for bullous keratopathy of the cornea – has been launched in Japan.
Having received regulatory and reimbursement approval earlier in 2024, in Japan, Aurion intends to work closely with corneal specialists there to adopt and disseminate their best practices for treating patients, said Aurion CEO Greg Kunst. Bullous keratopathy is usually treated by corneal transplantation using donor corneal tissue, but the supply of donor corneas has been chronically insufficient, he said.
Aurion’s proprietary process for propagating corneal endothelial cells in vitro was pioneered by Kyoto Prefectural University of Medicine’s Professor Shigeru Kinoshita. The benefits of over 25 years of research are now a reality for patients, Professor Kinoshita saidnjjh. “I am so grateful for the incredible contributions of my colleagues, my mentors, and Kyoto Prefecture University of Medicine… Most importantly, many thanks to my patients for helping me to understand their needs and for trusting us to develop this breakthrough regenerative medicine.”
Aurion also announced it has completed enrolment and dosing of 97 subjects in its phase 1/2 trial in the US and Canada. The US Food and Drug Administration recently granted both Breakthrough Therapy designation and Regenerative Medicines Advanced Therapy designation to Aurion Biotech.
