The First Artificial Iris in the United States is Approved by FDA

The FDA has approved the CustomFlex Artificial Iris, the first stand-alone prosthetic iris available in the United States.

The FDA recently approved the first stand-alone prosthetic iris in the United States. Clinical Research Consultants’ CustomFlex Artificial Iris a surgically implanted device to treat individuals whose iris is missing or damaged due to congenital 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, in a press release. “(The) 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.”

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 adult or child. A surgeon makes a small incision, inserts the device, 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 nonrandomized 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 postprocedure, health-related quality of life, and satisfaction with the appearance of the prosthesis. More than 70% of patients participating in the trial reported significant decreases in light sensitivity and glare, and 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 effects associated with the device or the surgical procedure. In the trial, 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, adhesion of the iris to the cornea or lens, 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, secondary surgery, corneal swelling, iritis, and retinal detachment.

The CustomFlex Artificial Iris is not recommended for eyes with any of the following conditions: uncontrolled or severe chronic inflammation, abnormally small eye size, untreated retinal detachment, untreated chronic glaucoma, cataract caused by rubella virus, abnormal blood vessels on the iris, certain kinds of damaged blood vessels in the retina, and intraocular infections. In addition, the device is contraindicated for patients who are pregnant.

The CustomFlex Artificial Iris was approved through a premarket approval application, and was granted Breakthrough Device designation.

Reference

FDA approves first artificial iris [news release]. Silver Spring, MD: May 30, 2018; FDA website. http://www.pharmacytimes.com/link/192. Updated June 4, 2018.