Aurion Biotech has announced the commercial launch of Vyznova (neltependocel) in Japan, marking what the company believes is the first approved allogeneic cell therapy for treating bullous keratopathy of the cornea. This milestone follows regulatory and reimbursement approvals in Japan and was inaugurated with cell therapy procedures performed by Professor Shigeru Kinoshita at Kyoto Prefecture University of Medicine (KPUM).
Addressing Bullous Keratopathy
Bullous keratopathy is a debilitating condition affecting the endothelial cells of the cornea, leading to water accumulation, blister formation, and severe pain. As the disease progresses, it causes corneal clouding, blurred vision, and potential blindness if left untreated. Professor Kinoshita, whose research and development efforts led to the creation of Vyznova, expressed gratitude to his colleagues, mentors, and patients for their contributions to this breakthrough regenerative medicine.
Overcoming Donor Tissue Shortages
Traditionally, bullous keratopathy has been treated with corneal transplantation using donor tissue. However, the availability of donor corneas is severely limited. According to a survey, only one donor cornea is available for every 70 diseased eyes globally. Aurion Biotech's innovative manufacturing process allows for the production of up to 1,000 doses of Vyznova from a single donor's corneal endothelial cells, significantly increasing treatment accessibility.
Clinical Development and Regulatory Status
Aurion Biotech is also conducting a Phase 1/2 clinical trial in the U.S. and Canada, having completed enrollment and dosing of 97 subjects. The U.S. FDA has granted Vyznova both Breakthrough Therapy designation and Regenerative Medicine Advanced Therapy designation, potentially expediting its review and approval in the United States.
Expert Perspectives
Greg Kunst, CEO of Aurion Biotech, stated that the commercial launch in Japan is exciting for patients worldwide suffering from corneal endothelial diseases. He added that the company intends to collaborate closely with corneal specialists in Japan to refine and disseminate best practices for treating this debilitating disease.
Michael Hasegawa, senior managing director for Aurion Biotech Japan, acknowledged the early investments in regenerative medicines from the Japanese government and expressed gratitude for Professor Kinoshita's leadership and collaboration, as well as the contributions of their CDMO partner, S-RACMO.
