The FDA gave the green light to HumanOptics’ artificial iris, which the company says is the first standalone prosthetic device of its kind available in the U.S.
Dubbed the CustomFlex Artificial Iris, the device won premarket approval from the regulatory agency with breakthrough device designation, the agency said.
It was cleared for use in both adults and children that have a missing or damaged iris either due to a congenital condition called aniridia or as the result of being damaged. Other indications approved for the device include conditions likes albinism, traumatic injury or surgical removal due to melanoma.
"Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye," Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices for the FDA, said in a statement. "Today's approval of the first artificial iris provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia."
The artificial iris, which is made from a thin, foldable medical-grade silicone and is custom-sized and colored for individual patients, is implanted through a small incision. The CustomFlex iris is then unfolded and smoothed using surgical instruments, and it is held in place by the anatomical structure of the eye or sutures.
Results from a clinical trial of 389 adult and pediatric patients with aniridia or other iris defects showed that 70% of patients reported significant decreases in light sensitivity and glare and improved health-related quality of life, while there was a 94% satisfaction rate among the patients with the appearance of the iris.