FDA Approves First Artificial Iris Implant

Regulatory NewsRegulatory News | 31 May 2018 |  By 

Clinical Research Consultants snagged US Food and Drug Administration (FDA) approval for the first stand-alone prosthetic iris.
The device, called the CustomFlex Artificial Iris, is designed to be surgically implanted through eye incisions for the treatment of iris defects, including those caused by rare genetic disorder congenital aniridia, albinism or traumatic injury, in adult and pediatric patient populations.
It is “made of thin, foldable medical-grade silicone and is custom-sized and colored for each individual patient,” FDA said in a late Wednesday announcement. After the artificial iris prosthetic device is inserted, it is “held in place by the anatomical structures of the eye or, if needed, by sutures.”
As part of the regulatory review process, the agency evaluated results of a non-randomized clinical trial that measured self-reported outcomes from a total of 389 adult and pediatric patients. Clinical Research Consultants also received breakthrough designation for the CustomFlex Artificial Iris—reviewed via the premarket approval application pathway, according to FDA.
“The first artificial iris provides a novel method to treat iris defects that reduces sensitivity to bright light and glare,” said Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at FDA's Center for Devices and Radiological Health (CDRH).
Contraindications for the new artificial iris include intraocular infections, untreated chronic glaucoma and cataract caused by rubella virus, among other health conditions.
Other recent ophthalmic device approvals include: In November 2017, FDA approved a first-of-its-kind medical device system from RxSight that allows for readjustment of implanted artificial lens post cataract surgery. And in April, IDx received FDA marketing authorization for a device powered by artificial intelligence and intended for the detection of certain diabetes-related eye problems, such as diabetic retinopathy.
The new approval comes as CDRH set a measure of success earlier this year to bring upwards 50% of manufacturers of novel technologies to the US first or in parallel with other major markets by the end of 2020.


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