GeekWire June 19, 2024
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...
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