The FDA today granted pre-market approval and a breakthrough device designation for HumanOptics‘ CustomFlex artificial iris, touting it as the first stand-alone prosthetic iris to win approval in the US.
The CustomFlex artificial iris is designed to be surgically implanted in adults and children to treat individuals whose iris is completely missing or damaged due to either a congenital condition called aniridia or other damage to the eye, according to an FDA release.
The newly cleared device is also indicated to treat iris defects due to other reasons or conditions, such as albinism, traumatic injury or surgical removal due to melanoma, the FDA said.
The CustomFlex iris is made of a thin, foldable medical-grade silicone and is custom-sized and colored for individual patients. The device is implanted through a small incision, after which it is unfolded and smoothed using surgical instruments. The iris is held in place by the anatomical structure of the eye or sutures, the federal watchdog said.
Approval came based on a non-randomized clinical trial of 389 adult and pediatric patients with aniridia or other iris defects, which measured patients self-reported decrease in severe sensitivity to light and glare post procedure, as well as health-related quality of life and satisfaction with cosmetic improvement or appearance.
Results from the study indicated that 70% of patients reported significant decreases in light sensitivity and glare and an improvement in health-related quality of life. Data also indicated a 94% satisfaction rate among the patients with the appearance of the iris.
“Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye. 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,” FDA’s Center for Devices and Radiological Health Ophthalmic, and Ear, Nose and Throat Devices division director Dr. Malvina Eydelman said in a press release.