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FDA Approves First Artificial Iris

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The U.S. Food and Drug Administration has announced its approval of the first stand-alone prosthetic iris in the United States that could help patients with certain types of eye damage see clearly and improve their appearance.

The surgically implanted device, called the CustomFlex Artificial Iris, is meant to treat adults and children whose iris — the part of the eye that is colored around the pupil — is damaged. Such damage may be caused by a congenital condition called aniridia, in which people are born with a partial or missing iris, or it could happen later in life from a traumatic injury or surgical removal due to melanoma. People born with albinism may also have eye problems that could be corrected with the device.

"Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye," Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health, said in a statement on Wednesday. "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 rare, affecting about 1 in every 50,000 to 100,000 people in the United States. The iris is completely or partially absent in people with the disorder.

Since the iris controls the amount of light entering the eye, those with aniridia often have a sensitivity to light and other vision problems. 

The CustomFlex Artificial Iris is surgically inserted and held in place by the eye's anatomical structures or, if needed, by sutures. It is made of thin, foldable medical-grade silicon and is custom-fitted and colored for each patient.

A study of nearly 400 adults and children with aniridia or other iris defects found that the device was safe and effective, with 70 percent of participants reporting significant decreases in light sensitivity and glare, as well as improvement in health-related quality of life. The study also found low rates of adverse side effects.

According to the FDA, the the CustomFlex Artificial Iris is not meant for use in patients who have uncontrolled or severe chronic inflammation, abnormally small eye size, untreated chronic glaucoma, cataract caused by the rubella virus, abnormal blood vessels on the iris, certain kind of damaged blood vessels in the retina, and inner eye infections. It is also not recommended for women who are pregnant.

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