The Food and Drug Administration has approved the first stand-alone artificial iris in the United States to treat adults and children.
The surgically implanted device is for people with an iris — the colored part of the eye around the pupil — that is completely missing or damaged due to a congenital condition called aniridia, or other damage.
On Wednesday, the FDA approved the artificial iris after a successful non-randomized clinical trial of 389 adult and pediatric patients with aniridia or other iris defects. More than 70 percent of patients reported significant decreases in light sensitivity and glare and improved health-related quality of life. Also, 94 percent of patients were satisfied with the artificial iris’ appearance.
The artificial iris is made of thin, foldable medical-grade silicone. It is custom-sized and colored for each individual patient.