A US Food and Drug Administration (FDA) safety communication was escalated to a Class I recall for Alcon’s CyPass micro-stent systems over risk of eye damage in implanted patients.
FDA’s safety communication was issued
last month based on a preliminary review of five-year post-surgery data from the COMPASS-XT study conducted by Alcon, the eye care division of Novartis. A second
FDA safety alert involving the CyPass device was issued Wednesday in conjunction with the recall notice
to update recommendations for ophthalmologists.
The updates come in light of “additional post-approval study data that confirm the recommendations made in September,” FDA said.
New recommendations in the updated safety communication direct eye care providers to periodically evaluate all patients who have had the CyPass device surgically implanted to monitor for “endothelial cell density using specular microscopy until the rate of loss stabilizes.” Details on how surgeons should conduct the clinical evaluations, which patients to prioritize and additional considerations are provided as well.
The new recommendations were made based on an FDA review showing more than 30% loss in endothelial cell density at five-year follow-up in 27.2% (44 out of a 162 total) of implanted patients. “The five-year endothelial cell loss data suggest that the general rate of cell loss does not plateau at five years post-implant,” the agency said.
FDA’s work to address the problem with the 2016-approved device began in August, following Alcon’s announced
decision to remove the CyPass micro-stent from the global market. Alcon CMO Stephen Lane said at the time the decision was based “out of an abundance of caution.”
The market action was "not related to a manufacturing or quality issue," Alcon spokesperson Lisa Gilbert told Focus
. "Rather, this market action is based on an analysis of the completed dataset from the COMPASS-XT long-term safety study. The analysis showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone."
In addition to the reiterated recommendations in the agency's new safety communication, the recall cautions against invasive procedures for a device removal after short postoperative periods and recommends other interventions such as trimming, per the recommendations first made in Alcon’s market withdrawal letter
“Data on surgical intervention to trim CyPass devices that were identified to be in suboptimal position was very limited in the study,” FDA clarified. “As a result, no conclusions could be made regarding the impact of trimming on endothelial cell loss progression.”
The only recommendation that remained unchanged involves not implementing the micro-stents and returning any unused devices is further stressed, with the recall notice identifying the problem as the most serious type of device recalls associated with serious injuries or death.
The recall notice also specifies the affected products, which include the CyPass Ultra System, the CyPass applier and the CyPass micro-stent—one of just four FDA-approved minimally invasive glaucoma surgery devices.