Indicated for the treatment of adults with mild-to-moderate primary open-angle glaucoma, the device was approved and launched in various markets for use in conjunction with cataract surgery.
This immediate market withdrawal is applicable to all CyPass Micro-Stent versions. The company has also asked surgeons to immediately stop further implantation of the device and to return any unused products.
The recall and related recommendation follows an analysis of five-year post-surgery data obtained during the COMPASS-XT long-term safety study.
COMPASS-XT was conducted to capture safety data of participants of the prior COMPASS study for an additional three years. The analysis was performed five years after surgery.
The US Food and Drug Administration’s (FDA) approval of the CyPass Micro-Stent in July 2016 was based on the landmark two-year COMPASS study results, which showed a statistically significant decrease in intraocular pressure at two years post-surgery in patients implanted at the time of cataract surgery.
COMPASS compared the results to those undergoing only cataract surgery and there was no significant difference observed in endothelial cell loss between CyPass Micro-Stent and cataract surgery only groups after two years.
However, the loss was found to be statistically significant at five years post-surgery in patients implanted with the device.
Alcon chief medical officer Stephen Lane said: “We believe that withdrawing the CyPass Micro-Stent from the market is in patients’ best interest and is the right thing to do.
“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.”
Alcon plans to directly offer recommendations to ophthalmic surgeons for assessing and managing patients that have already been implanted with the device.