First Ever Artificial Iris Approved by the FDA

The US Food and Drug Administration (FDA) has approved the first standalone prosthetic iris for adults and children whose iris is either completely missing or damaged due to a congenital condition.

The CustomFlex Artificial Iris, a thin, foldable medical-grade silicone prosthetic that is customizable by size and eye color for each patient, has been indicated for patients who suffer from aniridia or other damage to the eye. Aniridia is a rare genetic disorder in which the iris is completely or partially absent, and currently affects 50,000-100,000 people in the US.

The prosthetic is also indicated to treat iris defects such as albinism, traumatic injury, melanoma-driven surgical removal. It is capable of providing bright light and glare sensitivity reduction — a novel method for the treatment of iris defects, Malvina Eydelman, MD, director of the FDA’s Center for Devices and Radiological Health’s Division of Ophthalmic, Ear, Nose, and Throat Devices, said.

CustomFlex also improves cosmetic appearance of the eye in patienets with aniridia, Eydelman added.

The prosthetic is applied to the patient’s eye through a surgical incision that allows it to unfold and smooth out on the surface, and is held in place either by anatomical structures of the eye or by sutures.

Its effictiveness and safety was demonstrated primarily in a non-randomized clinical trial of 389 patients, both pediatric and adult, with aniridia or other iris defects. The trial measured patients' reports of severe light sensitivity and glade decreases following the procedure, as well as health-related quality of life, and satisfcation with the cosmetic improvement due to the prosthetic. According to HumanOptics AG, more than 70% of patients reported significant decreases in light sensitivity and glare, as well as improvements in health-related quality of life. Another 94% of patients were satistified with the appearance of the artificial iris.

Adverse events associated with the device or surgical procedure, which the company maintains were reported at low rates, included device movement or dislocation, increased ocular pressure or inflammation, increased intraocular pressure, and others.

CustomFlex was previously granted Breakthrough Device designation to expedite evidence generation and the FDA's review of the device, in response to its potential as a novel and necessary device. Its approval was based on a premarket approval application (PMA) which, according to the FDA, is the most stringent type of device marketing application generally required for high-risk devices.