The US Food and Drug Administration (FDA) has updated warning on Novartis division Alcon’s CyPass Micro-Stent, recommending clinicians to not implant the device and monitor already implanted patients.
Approved in 2016 to treat open-angle glaucoma during cataract surgery, the CyPass stents were voluntarily recalled by Alcon in August this year based on five-year data from the COMPASS-XT study.
At five years following cataract surgery, patients implanted with the CyPass Micro-Stent were found to experience statistically significant loss in endothelial cells.
Later in September, the FDA issued a safety communication based on a preliminary review of the study data and highlighted concerns on significant endothelial cell loss and reductions in the cell density.
During the recent review of additional post-approval study data, the regulatory agency found that 27.2 % of the implanted patients had more than 30% loss in endothelial cell density at five years.
Also, data revealed a correlation between the distance the CyPass Micro-Stent extends into the eye’s anterior chamber and the rate of endothelial cell loss.
The findings further suggested that the general rate of cell loss does not plateau at five years after implantation.
Based on the observations, the FDA still recommends clinicians to not use the stents and return them to Alcon. It also suggested that patients implanted with the device should be periodically assessed for endothelial cell loss.
A statement from the FDA read: “Eye care providers should evaluate all patients with CyPass to assess device positioning by visualisation of the number of retention rings visible on the proximal end of the device.
“Based on the endothelial cell density levels, and other factors such as age and time post-implantation, the surgeon should determine if additional surgical interventions are appropriate.”
Since its September announcement, the agency classified the CyPass Micro-Stent as a Class I recall and plans to continue reviewing any new data related to the stent.