The US Food and Drug Administration today approved the first stand-alone prosthetic iris in the United States, a surgically implanted device to treat adults and children whose iris (the colored part of the eye around the pupil) is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye.

“Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye,” said 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. “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.”

Congenital aniridia is a rare genetic disorder in which the iris is completely or partially absent. It affects approximately 1 in 50,000 to 100,000 people in the US. The iris controls the amount of light entering the eye, and those with aniridia have sensitivity to light and other severe vision problems. In addition to congenital aniridia, the CustomFlex Artificial Iris is indicated to treat iris defects due to other reasons or conditions, such as albinism, traumatic injury, or surgical removal due to melanoma.

The CustomFlex 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 safety and effectiveness of the CustomFlex Artificial Iris was demonstrated primarily in a non-randomized clinical trial of 389 adult and pediatric patients with aniridia or other iris defects. The study measured patients’ self-reported decrease in severe sensitivity to light and glare post-procedure, health-related quality of life, and satisfaction with the cosmetic improvement or appearance of the prosthesis. More than 70% of patients reported significant decreases in light sensitivity and glare as well as an improvement in health-related quality of life following the procedure. In addition, 94% of patients were satisfied with the artificial iris’ appearance.

The study found low rates of adverse events associated with the device or the surgical procedure. In the study, complications associated with the use of the CustomFlex Artificial Iris device included: device movement or dislocation, strands of device fiber in the eye, increased intraocular pressure, inflammation of the iris (iritis), adhesion of the iris to the cornea or lens (synechiae), and the need for secondary surgery to reposition, remove, or replace the device. Complications associated with the surgical procedure included increased intraocular pressure, blood leakage in the eye, swelling of the center of the retina (cystoid macular edema), secondary surgery, corneal swelling, iritis, and retinal detachment.

The CustomFlex Artificial Iris is contraindicated, or should not be used, in eyes with any of the following conditions: uncontrolled or severe chronic inflammation (uveitis), abnormally small eye size (microphthalmus), untreated retinal detachment, untreated chronic glaucoma, cataract caused by rubella virus, abnormal blood vessels on the iris (rubeosis), certain kinds of damaged blood vessels in the retina, and intraocular infections. It is also contraindicated for patients who are pregnant.

The CustomFlex Artificial Iris was approved through a premarket approval application (PMA), which is the most stringent type of device marketing application and generally required for high-risk devices. A PMA approval is primarily based on a determination by the FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended uses.

CustomFlex Artificial Iris was granted Breakthrough Device designation, meaning the FDA provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency’s review of the device. To qualify for such designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition, and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.

The FDA granted approval of the CustomFlex Artificial Iris to HumanOptics AG.