RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 8 > Alcon Pulls CyPass Microstent From Global Market ‘Out of an Abundance of Caution’

Alcon Pulls CyPass Microstent From Global Market ‘Out of an Abundance of Caution’

Posted 31 August 2018 | By Ana Mulero 

Alcon Pulls CyPass Microstent From Global Market ‘Out of an Abundance of Caution’

Alcon, the eye care division of Novartis, said this week it is pulling all versions of its CyPass micro-stent from the global market based on the results of a five-year post-approval study.

The COMPASS-XT study tracked data on patients who had completed the two-year COMPASS study that resulted in the 2016 US Food and Drug Administration (FDA) approval of the microinvasive glaucoma surgery device for use with cataract surgery. Analysis of the resulting additional data showed patients implanted with the stent experienced endothelial cell loss.

These results in turn led to the decision to withdraw the product from the market, at least temporarily, “out of an abundance of caution,” Alcon CMO Stephen Lane said. “We intend to partner with the FDA and other regulators to explore labeling changes that would support the reintroduction of the CyPass micro-stent in the future.”

The decision comes just a few months after Alcon introduced a system that features preloaded CyPass micro-stents to aid surgeons in the device implantation and touted interim results from the COMPASS-XT study. The company had been encouraged by its data results up until now.

It also follows on the heels of a proposal from parent company, Novartis, in June to spinoff the 2011-acquired subsidiary for a buyback of up to $5 billion. Novartis is reportedly still on track to complete its spinoff of Alcon into a standalone company by the end of next year, despite the setback.

A transcript from a 2014 FDA public workshop, which discussed results of a CyPass study published the year prior, reported the most common complication had been transient early hypotony, which was attributed “to micro-stent placement and creation of small cyclodialysis clefts.

FDA Commissioner Scott Gottlieb took to Twitter to point to Alcon's decision. The agency previously proposed a renewed push to ensure compliance with requirements on reporting device recalls and market withdrawals.


© 2022 Regulatory Affairs Professionals Society.