VEO Ophthalmics Launches CUSTOMFLEX® ARTIFICIALIRIS in the U.S.
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VEO Ophthalmics Launches CUSTOMFLEX ® ARTIFICIALIRIS in the U.S.
Ophthalmic surgeons and their patients now have access to the first FDA-approved iris prosthesis.
CINCINNATI, Ohio – September 27, 2018 – VEO Ophthalmics, LLC, today 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 U.S. 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,” said Dr. Pierre Billardon, CEO of HumanOptics.
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.”
The iris is the colored part of the eye surrounding the pupil. 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.
About VEO Ophthalmics
Located in Cincinnati, Ohio, VEO Ophthalmics, LLC, is a developer and distributor of ophthalmic surgical technologies. VEO focuses on improving patient care by partnering with leading ophthalmic surgeons to develop innovative tools for today’s challenging surgical environment. Close relationships with ophthalmic healthcare customers and business partners help VEO ensure that its products and service experience meet the highest standards.
To learn more, visit VEO at www.veo-ophthalmics.com.
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