Federal regulators are warning about a risk of problems with CyPass Micro-Stent eye implant, which have been recalled from the market amid reports of complications following glaucoma surgery.
The FDA issued a safety communication on September 14, targeting individuals who have a CyPass Micro-Stent to treat open-angle glaucoma, and eye care providers. The communication comes about two weeks after the manufacturer announced a CyPass Micro-Stent recall.
“This notice is to alert eye care providers and patients of the risk of eye damage in people who have the device implanted,” the agency states in the safety communication. “Based on information from a post-approval study required by the FDA, Alcon (the manufacturer) is collecting all unused devices (voluntary market withdrawal) and is asking physicians to stop implanting the device.”
The CyPass Micro-Stent is a device implanted in a person’s eye during glaucoma surgery, to help lower eye pressure and prevent the progression of glaucoma; however, it can pose other complications.
The recall is global, affecting all micro-stent devices currently on the market.
The decision to remove the eye micro-stent from the market was made based on five-year followup data from the COMPASS-XT long-term safety study, which indicated that the stent may cause damage to the endothelial cells of the eye.
The FDA approved the CyPass Micro-Stent in July 2016, for use along with cataract surgery in patients with mild-to-moderate primary open-angle glaucoma. The approval came from the results of a two-year COMPASS-XT study.
Research indicated that at the two-year post-op mark, the patients who had the CyPass Micro-Stent and the patients who had only cataract surgery had similar low rates of endothelial cell loss, or eye damage. Based on the early two-year results, the FDA approved the Micro-Stent. However, by the five year post-op mark researchers found significant endothelial cell loss among the CyPass Micro-Stent group compared to cataract surgery patients. The endothelial loss could lead to further damage to the eye or vision loss.
The FDA urges eye care providers not to implant CyPass Micro-Stents and return unused devices to Alcon. It also urged them to review the company’s recommendations for evaluating and managing CyPass Micro-Stents in patients who already have the device. The FDA also warns that it does not know what might happen more than five years after surgery and what removing the device would do to the rate of endothelial cell density loss.
The agency also called on patients to make an appointment with their eye care provider as soon as possible so they can explain the options available.
The FDA also noted that it is continuing to evaluate the data and the concerns reported.
Patients or eye care providers who experience adverse events linked to the CyPass Micro-Stent should also contact the FDA MedWatch reporting program to report side effects.