Aurion Biotech Submits IPO Prospectus Following Global First Approval of Allogeneic Cell Therapy Vyznova for Corneal Endothelial Disease

Mar 30, 2023 17:44 CST Updated 17:44

Aurion Biotech

Developer of Advanced Therapies for Eye Diseases

PMDA

The PMDA is responsible for preventing adverse reactions to pharmaceuticals and biologics, as well as conducting timely assessments and responses to such risks, thereby helping to enhance the quality, efficacy, and safety of medicinal products and improve public health. Its scope of work includes providing relief for adverse drug reactions, reviewing pharmaceuticals, medical devices, and related businesses in accordance with the law, ensuring the safety of pharmaceuticals and medical devices, and disseminating information on safety measures and medical products.

Aurion Biotech Announces PMDA Approval of Vyznova, the World’s First Allogeneic Cell Therapy for Corneal Endothelial Disease

Greg Kunst

Aurion's CEO, Greg Kunst, stated: "The approval of Vyznova in Japan marks several 'firsts' for millions of patients in need, for regenerative medicine, and for Aurion Biotech. This is the first approved cell therapy for the treatment of corneal endothelial disease. The Aurion team, with its deep experience in the development and manufacturing of cell therapies, is applying the landmark invention of Professor Shigeru Kinoshita and his team to large-scale clinical cell therapy development—first in Japan, and then globally."

Vyznova is an off-the-shelf, allogeneic cell therapy that represents a completely new treatment approach for corneal endothelial dysfunction. Healthy cells from donor corneas are cultured through Aurion's proprietary innovative, multi-step process to generate fully differentiated corneal endothelial cells. This process does not involve genetic editing, and the cells from one healthy volunteer donor can theoretically treat up to 100 patients. Compared with traditional treatments, this novel cell therapy is far less invasive, allowing patients to get up and move within hours after the surgery.

Company R&D Pipeline

Aurion Biotech, founded in 2021, is dedicated to restoring patients' vision through regenerative therapies. Aurion Biotech is a spin-off of the leading ophthalmic care company, CorneaGen.

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