The U.S. Food and Drug Administration recently approved the CustomFlex Artificial Iris (HumanOptics/Clinical Research Consultants) for the treat-ment of vision and cosmetic problems arising from congenital, surgical or traumatic aniridia in adults and children. As its name indicates, the CustomFlex is a thin, flexible artificial iris made of medical-grade silicone that’s customized to the patient for size and iris color.
In practice, the provider takes a photo of the unaffected eye. (In the case of bilateral aniridia, the patient chooses the eye’s appearance.) The manufacturer hand-paints a replica of the index iris to create the CustomFlex, which can be rolled to enter the eye through a small incision, and then smoothed flat after insertion. This may mean a less-traumatic procedure for aniridic eyes—which often have comorbid conditions—compared to rigid aniridia devices that may require larger incisions. The surgeon can trephine the CustomFlex to fit into the sulcus if it’s too large; he or she can also cut it to cover smaller segmental iris defects.
The artificial iris can be useful in counteracting the psychological distress arising from the aniridic eye’s appearance, as well as the accompanying light sensitivity and glare. The CustomFlex was granted Breakthrough Device Designation to expedite the regulatory path of the implant. Trial investigator Michael E. Snyder, MD, on the Board of Directors at Cincinnati Eye Institute and a volunteer faculty member at the University of Cincinnati, says, “Once the study data was submitted, the approval came quickly with the FDA’s new Breakthrough Devices pathway. This unique product can be life-changing for patients.” The CustomFlex met the following criteria to qualify for this designation: the device must provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition; the device must also be either a breakthrough technology, have no approved or cleared alternatives, or its availability must be in the best interest of patients.
Dr. Snyder and other investigators at sites around the country have been offering patients access to the device since 2013 through a nonrandomized interventional study comprising a PMA study cohort, a continued-access cohort and a compassionate-use cohort. “In addition to reduction of photic symptoms, the custom-made device is crafted to match a picture taken from an unaffected eye, so that improvement in cosmesis is also a happy outcome of implantation,” says Dr. Snyder. Outcomes included patients’ self-reports of decreased light and glare sensitivity, improved health-related quality of life and satisfaction with cosmetic appearance of the operated eye. More than 70 percent of 389 patients reported significantly less light and glare sensitivity postoperatively as well as improved health-related quality of life after surgery. Ninety-four percent of the CustomFlex patients reported satisfaction with the appearance of the prosthetic iris.
Adverse events arising from the device or the surgery in the study were rare, but included: the device shifting or dislocating in the eye; strands of fiber from the device in the eye; increased IOP; iritis; synechiae; and a need for second procedure to reposition, remove or replace the prosthesis. Surgical complications reported included increased IOP, blood leakage in the eye, cystoid macular edema, iritis, retinal detachment and secondary surgery.
Kevin M. Miller, MD, professor of clinical ophthalmology, David Geffen School of Medicine at UCLA, says that although he and fellow investigators are thrilled by the FDA approval, the CustomFlex still needs to surmount some regulatory and insurance hurdles. “All of the investigators involved in the HumanOptics clinical trial are elated with the recent FDA approval of the CustomFlex artificial iris device. The approval represents the culmination of years of collaborative effort by many individuals. FDA labeling issues will have to be resolved before the product can be sold commercially in the United States. Thereafter, insurance coverage issues will have to be tackled and ophthalmologists who wish to implant the device will have to be trained. However, FDA approval is a major step in the forward direction. It’s a huge win for patients with iris defects. The CustomFlex device is not only safe and effective, it’s also cosmetically beautiful and it gives patients another option for dealing with a debilitating problem.” REVIEW