Seattle’s Aurion Biotech announced Wednesday that it received special designations from the U.S. Food and Drug Administration that should speed up the development of its treatment for a common disease that damages the cornea and can result in vision loss.
The FDA granted Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation for Aurion’s cell therapy treatment.
The designations accelerate the FDA’s review process, and are given to efforts that target serious diseases and offer significant improvements over currently available options.
Degeneration of the cornea with age or disease can result in a condition called corneal edema secondary to endothelial dysfunction. Associated with impaired, hazy vision and ultimately blindness, the condition affects millions of people globally, and about 4% of people over age 40 in the U.S.
Aurion recently completed the enrollment of 97 patients in a Phase 1 / 2 clinical trial being conducted in the U.S. and Canada. Its cell therapy has been approved for use in Japan.
Existing treatment for the condition includes corneal transplants, which are effective. But there is an insufficient supply of available tissue and the post-operative recovery requires a patient to lie flat on their back for up to three days to ensure the cornea adheres correctly.
Aurion, a spinoff of Seattle eye care company CorneaGen, has offices in Seattle, Tokyo and Cambridge, Mass. The company’s corneal therapy is based on technology Aurion licensed in 2020 from the Kyoto Prefecture University of Medicine.
In 2022, Aurion announced a $120 million Series C round of funding.
Ernst & Young on Monday named Aurion CEO Greg Kunst as its Entrepreneur of the Year for the Mountain West Region.
