FDA Approves First Artificial Iris for Aniridia

Today, the US Food and Drug Administration (FDA) approved the first artificial iris for both pediatric and adult patients with aniridia who have an iris that is completely missing or damaged. The surgically implanted device can also be used for other damages done to the eye.

Congenital aniridia is a rare genetic disorder characterized by the complete or partial absence of the iris.

“Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye,” commented 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 in a recent statement. “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.”

Each CustomFlex Artificial Iris is custom-sized and colored for each patient, and it is engineered out of thin, foldable medical-grade silicone. A small incision is performed by a surgeon, who then places the device under the incision, unfolds it, and smooths out the edges with surgical instruments. The anatomical structures of the eye (or sutures if need be) hold the prosthetic iris in place by or, if needed, by sutures.

A non-randomized clinical trial of 389 adult and pediatric patients with aniridia or other iris defects demonstrated the safety and efficacy of the CustomFlex Artificial Iris. 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 were measured.

Significant decreases in over 70% of patients were reported regarding sensitivity and glare. An improvement in health-related quality of life following the procedure was also reported. Additionally, the artificial iris’ appearance satisfied 94% of patients. The study also showed that low rates of adverse events were connected with the device or the surgical procedure.

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 included the listed complications pertaining to the use of the CustomFlex Artificial Iris device in the study.

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 included complications pertaining to the surgical procedure.

Eyes with 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 should not use the CustomFlex Artificial Iris.

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