The COMPASS-XT five-year analysis reported that patients treated with the micro-stent experienced statistically significant loss of endothelial cells compared to the patients treated with lone cataract surgery.
Alcon, an eye health care division of Novartis, has announced a voluntary global market withdrawal for its CyPass Micro-Stent device, indicated for patients with surgical glaucoma.
The decision to withdraw the device—which was approved in July 2016 by the US Food and Drug Administration (FDA) for the use in conjunction with cataract surgery for mild-to-moderate primary open-angle glaucoma in adult patients—is based on the results of five-year data from the long-term safety COMPASS-XT study.
The study, designed to collect safety data on the participants of the COMPASS study for 3 years beyond its end and analyze data sets at their five-year post-surgery mark, reported that patients treated with the micro-stent experienced statistically significant loss of endothelial cells compared to the patients treated with lone cataract surgery.
Prior to this five-year finding, the COMPASS study had reported statistically significant intraocular pressure reduction at 2 years post-surgery in patients implanted with the micro-stent versus lone cataract surgery patients. There was also little difference in endothelial cell loss between the 2 patient groups at 2 years.
The voluntary withdrawal will apply to all versions of the micro-stent, according to Alcon. The company will directly communicate with ophthalmic surgeons using the product to provide advice on evaluating and managing patients who have already received the micro-stent, as well as instructions as how to return unused devices.
Stephen Lane, MD, chief medical officer of Alcon, said the company believes withdrawing the product is both in the best interest of patients and “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 labeling changes that would support the reintroduction of the CyPass Micro-Stent in the future,” Lane said in a statement.