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Regulatory Focus™ > News Articles > 9 > FDA Follows Up on Alcon’s CyPass Withdrawal With Eye Damage Risk Alert

FDA Follows Up on Alcon’s CyPass Withdrawal With Eye Damage Risk Alert

Posted 17 September 2018 | By Ana Mulero 

FDA Follows Up on Alcon’s CyPass Withdrawal With Eye Damage Risk Alert

The US Food and Drug Administration (FDA) issued a safety communication on Friday to alert of a potential risk of eye damage in patients who have Alcon's CyPass micro-stent implanted.
 
The notice follows on the heels of last month’s announcement from Alcon—Novartis’ eye care unit—voluntarily withdrawing all versions of its CyPass micro-stent from global markets.
 
Both the market withdrawal and the safety alert are based on the findings from a post-approval study that was set as a requirement when the eye implant received FDA’s conditional approval in 2016. The agency received the company’s two-year post-approval study report on 25 July.
 
“Initial review of the five-year data for patients from the post-approval study shows a concerning difference in the degree of corneal cell loss in patients who received the CyPass device compared to those who did not receive it,” the agency said. “At five years, patients who have the device had less endothelial cell density than the control group.”
 
Endothelial cells “are important in keeping vision clear” and “do not regrow after they are damaged,” according to FDA.
 
The agency has not found adverse events similar to the long-term endothelial cell loss issues linked to the CyPass micro-stent to be associated with any of the other three minimally invasive glaucoma surgery devices that have obtained FDA approval, according to the safety alert.
 
The review of the post-approval data is ongoing. But Alcon and FDA are directing surgeons to immediately cease implantation and return any unused Cypass micro-stents to the company.

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