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FDA Approves First Stand-Alone Artificial Iris

By Staff
Friday, June 1, 2018 12:30 AM


SILVER SPRING, Md.—The U.S. Food and Drug Administration approved the first stand-alone prosthetic iris in the U.S., 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. The device was developed by HumanOptics AG, a medical technology company based in Erlangen, Germany.

“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 U.S. The iris controls the amount of light entering the eye, and those with aniridia have sensitivity to light and other severe vision problems, according to the FDA. 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.

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.
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