Aurion Biotech announces commercial launch of neltependocel (Vyznova) in Japan

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Aurion Biotech announced the commercial launch of neltependocel (Vyznova) in Japan for the treatment of bullous keratopathy of the cornea. Vyznova has received both regulatory and reimbursement approval in Japan.

Bullous keratopathy is a sight-threatening and debilitating condition affecting the endothelial cells of the cornea. Water accumulation in the form of blisters on the cornea can cause severe pain. As the condition progresses, vision deteriorates, and patients may experience blurred vision, glares and halos when staring at bright lights, difficulty with night driving, and overall discomfort. When left untreated, symptoms may worsen over time potentially leading to blindness.¹

Prior to Vyznova, bullous keratopathy was treated by corneal transplantation using donor corneal tissue. The lack of corneal tissue in Japan caused a significant challenge in the treatment of bullous keratopathy.¹

“Our commercial launch in Japan is exciting for patients around the world who suffer from corneal endothelial diseases,” said Greg Kunst, CEO of Aurion Biotech in a press release from the company. “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.”

According to a press release from Aurion, the launch of Vyznova was celebrated with cell therapy procedures by Shigeru Kinoshita, MD, PhD, at Kyoto Prefecture University of Medicine (KPUM) in Kyoto, Japan. Kinoshita pioneered the research and development of corneal endothelial cell therapy, and the proprietary process for propagating corneal endothelial cells in vitro, and according to the company, the technology was acquired from Kinoshita and KPUM several years ago.1

Kinoshita commented on the commercial launch in a press release from Aurion stating “The benefits of over 25 years of our research are now a reality for patients. I am so grateful for the incredible contributions of my colleagues, my mentors, and Kyoto Prefecture University of Medicine for our shared hard work to achieve this milestone. Most importantly, many thanks to my patients for helping me to understand their needs and for trusting us to develop this breakthrough regenerative medicine.”

In the US, Aurion recently received Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) Designation for AURN001, the company’s allogeneic cell therapy candidate for the treatment of corneal edema secondary to corneal endothelial disease.

Additionally, Aurion also recently completed dosing of 97 subjects in its phase 1/2 CLARA trial in the US and Canada, evaluating the safety, tolerability, and efficacy of AURN001 for the treatment of corneal edema secondary to corneal endothelial dysfunction.

References:

1. Aurion Biotech Launches Vyznova® (neltependocel) in Japan for the Treatment of Bullous Keratopathy of the Cornea. Press Release; September 24, 2024. Accessed September 25, 2024. https://www.businesswire.com/news/home/20240924085009/en/Aurion-Biotech-Launches-Vyznova%C2%AE-neltependocel-in-Japan-for-the-Treatment-of-Bullous-Keratopathy-of-the-Cornea