Clinical Research Consultants has secured the US Food and Drug Administration (FDA) approval for its stand-alone artificial iris, CustomFlex Artificial Iris.
The product is indicated for people with a missing or damaged iris due to the congenital disorder aniridia or other types of eye damage.
Made of thin, foldable medical-grade silicone, the CustomFlex Iris is custom-sized and coloured for an individual patient.
The artificial iris is implanted by a surgeon through an incision, where it is retained by the eye’s anatomical structures or by sutures in certain cases.
FDA Ophthalmic, and Ear, Nose and Throat Devices division director Malvina Eydelman said: “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 reduce sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.”
The regulatory agency’s decision comes after a review of data from a non-randomised clinical trial designed to assess the prosthetic iris’ safety and effectiveness in 389 adult and paediatric patients with various iris defects, including aniridia.
During the study, subjects were asked to self-report any reduction in severe sensitivity to light and glare after the surgical procedure, quality of life and satisfaction with the prosthesis’ appearance.
About 70% of the participants reported having experienced a significant decrease in light sensitivity and glare along with health-related quality of life improvements, while 94% were satisfied with the appearance.