In its first approval of an artificial iris, the FDA approved HumanOptics’ CustomFlex, a surgically implanted device to treat adults and children whose iris is completely missing or damaged.
The device is indicated to treat defects due to aniridia — a congenital condition that affects approximately 1 in 50,000 to 100,000 people in the U.S. — as well as other conditions such as albinism, traumatic injury or surgical removal due to melanoma.
The implant is made of thin, foldable silicone and is custom-sized and colored for each patient. Safety and effectiveness was demonstrated in a 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 as well as an improvement in health-related quality of life following the procedure.