Aurion Biotech, based in Seattle, recently received special designations from the U.S. Food and Drug Administration that will accelerate the development of its cell therapy treatment for corneal edema secondary to endothelial dysfunction. The FDA granted Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation to Aurion, recognizing the potential of the treatment to significantly improve upon existing options for this common disease that can lead to impaired vision and blindness. This designation will expedite the FDA’s review process for Aurion’s therapy, speeding up the path to potential approval and availability for patients in need.
Corneal edema secondary to endothelial dysfunction can affect millions of people globally, with about 4% of people over the age of 40 in the U.S. experiencing this condition. Existing treatments such as corneal transplants have limitations, including a limited supply of available tissue and a lengthy recovery process post-operation. Aurion’s cell therapy aims to provide a more effective and efficient alternative to traditional treatments, offering hope to those suffering from this debilitating condition. The company recently completed enrollment in a Phase 1 / 2 clinical trial in the U.S. and Canada, with approval for use in Japan already secured.
Aurion, a spinoff of Seattle eye care company CorneaGen, is at the forefront of developing innovative therapies for corneal diseases. The company’s technology, licensed from the Kyoto Prefecture University of Medicine in 2020, forms the basis of its cutting-edge treatment for corneal edema. With offices in Seattle, Tokyo, and Cambridge, Mass., Aurion is well-positioned to advance its research and bring its therapies to market. The recent $120 million Series C funding round in 2022 further validates the potential of Aurion’s approach to addressing unmet medical needs in the field of ophthalmology.
CEO Greg Kunst of Aurion was recognized as Ernst & Young’s Entrepreneur of the Year for the Mountain West Region, highlighting his leadership and vision in driving the company’s success. With a dedicated team of researchers and experts in the field, Aurion is poised to make a significant impact on the treatment of corneal diseases and improve the lives of patients suffering from vision-threatening conditions. The FDA designations granted to Aurion underscore the importance of advancing innovative regenerative therapies and accelerating the development of potentially life-changing treatments for those in need.
In conclusion, the specialized designations received from the FDA mark a significant milestone for Aurion Biotech and its efforts to advance cell therapy treatment for corneal edema secondary to endothelial dysfunction. The recognition of Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation highlights the potential of Aurion’s therapy to address a common and debilitating disease, offering hope to individuals affected by corneal degeneration. With ongoing clinical trials and regulatory milestones, Aurion is moving closer to bringing its innovative treatment to market and making a meaningful impact on ophthalmic care.
