09.27.18

First FDA-Approved Iris Prosthesis Now Available in the United States

Source: VEO Ophthalmics

VEO Ophthalmics announced the launch of the ‘Customflex ArtificialIris,’ the first iris prosthesis available in the United States. The surgically implanted device received FDA approval on May 30, 2018 for use in children and adults for the treatment of iris defects resulting from congenital aniridia, acquired defects or other conditions associated with a completely or partially missing or damaged iris.

VEO has entered into an exclusive agreement with HumanOptics, the manufacturer of the Customflex ArtificialIris, to bring this technology into the U.S. market.

“Since 2013 the Customflex ArtificialIris has been successfully implanted in more than 600 patient’s eyes throughout the US,” Dr. Pierre Billardon, CEO of HumanOptics, said in a company news release. “With FDA approval complete, we are very excited to partner with VEO Ophthalmics to deliver this breakthrough technology to many more Americans who suffer from aniridia.”

Ron Gilliland, President and CEO of VEO Ophthalmics, added, “We are very pleased to bring the Customflex ArtificialIris to ophthalmic surgeons and their patients within the U.S. The success of the FDA trial has shown this technology can have a tremendous positive impact on those suffering from congenital aniridia and many other iris deformities.”  

People may have a damaged or missing iris from birth or as a result of sports injuries or other trauma, disease, or surgery. They struggle to cope not only with the appearance of their eye, but also with symptoms related to the eye’s inability to control the level of incoming light, including light sensitivity, glare, halos, reading difficulty, and problems with night driving. Many face above-average risk of glaucoma and cataract formation as well.

The Customflex ArtificialIris addresses both symptomatic and cosmetic aspects of iris defects. Every Customflex ArtificialIris is custom-made. Medical-grade colorized silicone is applied to the implant to match a patient’s natural iris, based on a selected color photograph, producing a nearly exact match to the patient’s other eye. After surgical implantation of the Customflex ArtificialIris, patients can go home the same day.

In a non-randomized clinical trial of 389 adult and pediatric patients who had the Customflex ArtificialIris implanted in one or both eyes for the treatment of congenital aniridia or other iris defects (Sponsor Clinical Research Consultants, Inc.), more than 70% of the study patients reported decreases in light sensitivity and glare, as well as improvement in health-related quality of life. In surveys, 94% of the study patients rated the appearance of their eyes as improved, much improved, or very much improved after the iris prosthesis was implanted.

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