Seattle-based biotech company Aurion Biotech recently received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation from the U.S. Food and Drug Administration for its cell therapy treatment that targets corneal edema secondary to endothelial dysfunction. This special designation will expedite the FDA review process and provide significant improvements over current treatment options for the condition that can lead to impaired vision and blindness. Aurion has completed enrollment in a Phase 1 / 2 clinical trial in the U.S. and Canada, as well as received approval for its cell therapy in Japan.
Corneal edema, caused by age or disease-related degeneration of the cornea, affects millions of people worldwide, with about 4% of people over the age of 40 in the U.S. being impacted. Current treatment options for the condition include corneal transplants, which are effective but face challenges such as a limited supply of available tissue and lengthy post-operative recovery periods. Aurion’s cell therapy offers a promising alternative that could address these challenges and provide better outcomes for patients suffering from corneal edema.
Aurion Biotech, a spinoff of Seattle eye care company CorneaGen, has offices in Seattle, Tokyo, and Cambridge, Mass., and is focused on developing novel treatments for ocular diseases. The company’s corneal therapy technology was licensed from the Kyoto Prefecture University of Medicine in 2020. In 2022, Aurion announced a $120 million Series C funding round to further support its research and development efforts in advancing cutting-edge treatments for eye disorders.
The FDA designations granted to Aurion’s cell therapy highlight the importance and potential impact of the company’s innovative approach to treating corneal edema. By receiving Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation, Aurion’s treatment has been recognized as a significant advancement in the field of regenerative medicine and could pave the way for faster approval and accessibility for patients in need of effective solutions for corneal disorders.
CEO Greg Kunst of Aurion Biotech was recently honored as Entrepreneur of the Year for the Mountain West Region by Ernst & Young, recognizing his leadership and dedication to driving innovation in the biotech sector. With a strong focus on developing safe and effective treatments for ocular diseases, Aurion continues to make significant strides in the advancement of regenerative medicine and the improvement of patient outcomes for individuals suffering from corneal conditions.
Overall, the FDA designations, ongoing clinical trials, strategic partnerships, and funding support underscore Aurion Biotech’s commitment to revolutionizing the treatment of corneal edema and other ocular diseases. With a team of dedicated researchers and experts, Aurion is well-positioned to make a meaningful impact in the field of regenerative medicine and provide hope for patients with vision-threatening conditions.
