USA – 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…