FDA approves CustomFlex artificial iris

The FDA has approved a prosthetic device to replace a missing or damaged iris, the agency announced. Approval of the CustomFlex artificial iris was granted to HumanOptics AG.

“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,” Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health, said in a press release.

The CustomFlex artificial iris is indicated to treat congenital aniridia, as well as iris defects resulting from other conditions such as albinism, trauma or surgical removal, according to the announcement.

The artificial iris “is made of thin, foldable medical-grade silicone and is custom-sized and colored for each individual patient. A surgeon makes a small incision, inserts the device under the incision, unfolds it and smooths out the edges using surgical instruments. The prosthetic iris is held in place by the anatomical structures of the eye or, if needed, by sutures,” the FDA announcement said.

In clinical trials, 94% of patients reported satisfaction with the appearance of the artificial iris, and 70% of patients reported a significant decrease in light sensitivity and glare.