Due to concerns that Alcon’s CyPass Glaucoma Micro-Stent may cause damage to a person’s eye, surgeons are being advised to stop using the device during glaucoma surgery.
The FDA announced a Alcon CyPass Micro-Stent recall August 29, indicating that safety data from a long-term follow up study found that the device poses an unreasonable risk.
The CyPass Micro-Stent is a device implanted in a person’s eye during glaucoma surgery, to help lower eye pressure and prevent the progression of glaucoma; however, it can pose other complications.
The recall is global, affecting all micro-stent devices currently on the market.
The decision was made based on five-year followup data from the COMPASS-XT long-term safety study, which indicated that the stent may cause damage to the endothelial cells of the eye.
The FDA approved the CyPass Micro-Stent in July 2016, for use along with cataract surgery in patients with mild-to-moderate primary open-angle glaucoma. The approval came from the results of a two-year COMPASS-XT study.
The Compass-XT study was designed to collect safety data on participants who had the CyPass Micro-Stent implanted for an additional three years past the initial two year.
The results of the study showed a significant reduction in intraocular pressure at the two year post-surgery mark among patients who had the CyPass Micro-Stent implanted during cataract surgery, compared to those who only had cataract surgery completed.
Research indicated that at the two-year post-op mark, the patients who had the CyPass Micro-Stent and the patients who had only cataract surgery had similar low rates of endothelial cell loss, or eye damage. Based on the early two-year results, the FDA approved the Micro-Stent. However, by the five year post-op mark researchers found significant endothelial cell loss among the CyPass Micro-Stent group compared to cataract surgery patients. The endothelial loss could lead to further damage to the eye or vision loss.
For that reason, Alcon initiated the market withdrawal for all versions of CyPass Micro-Stent. Alcon has indicated it will contact surgeons to give recommendations on how to evaluate and manage the patients who have already received CyPass Micro-Stent surgery.
Alcon is also warning ophthalmic surgeons to stop CyPass Micro-Stent implantations immediately and return unused devices to the company.
“We believe that withdrawing the CyPass Micro-Stent from the market is in patients’ best interest and is the right thing to do,” said Dr. Stephen Lane, Chief Medical Officer at Alcon. “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.”
Patients who experienced side effects or vision problems following the implantation of the CyPass Micro-Stent should notify their doctor immediately. They should also contact the FDA MedWatch reporting program to report side effects.