The first stand-alone prosthetic iris for use in the U.S. has been approved by the U.S. Food and Drug Source: HumanOptics AGAdministration (FDA). The CustomFlex Artificial Iris from HumanOptics AG of Germany is 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 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 artificial iris was demonstrated 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 percent 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 percent of patients were satisfied with the artificial iris appearance.

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 Clinical Research Consultants Inc.