Citing “uncompromising commitment to patient safety,” Alcon has announced an immediate, voluntary withdrawal of all versions of the CyPass micro-stent from the global market and advises surgeons to immediately cease further implantation of the device.
According to a company press release, the decision was based on safety data from the COMPASS-XT study, which found a statistically significant difference in endothelial cell loss at 5 years after surgery in patients who received the device in conjunction with cataract surgery compared to those who underwent cataract surgery alone.
The CyPass micro-stent has been FDA approvedfor use in conjunction with cataract surgery for treatment of mild-to-moderate primary open-angle glaucoma since July 2016. That approval was based on 2-year results of the COMPASS study, which “were consistent with peer-review literature benchmarks of cataract-related endothelial cell loss,” according to the release.
The company will contact ophthalmic surgeons directly with recommendations how to proceed, according to the release.
“Although we are removing the product from the market now out of an abundance of caution, we intend to partner with the FDA and other regulators to explore labelling changes that would support the reintroduction of the CyPass micro-stent in the future,” Dr Stephen Lane, MD, chief medical officer for Alcon, said.