Alcon Pulls CyPass Glaucoma Micro-Stent Off the Global Market

Megan Brooks

Disclosures

August 31, 2018

Alcon is voluntarily taking all versions of the CyPass Micro-Stent off the market globally, effective immediately, on the basis of 5-year data from COMPASS-XT long-term safety study, the company has announced.

Ophthalmic surgeons should stop implanting the device immediately and return any unused devices to Alcon, the company said.

The US Food and Drug Administration (FDA) approved the CyPass stent in July 2016 for use in conjunction with cataract surgery in adults with mild to moderate primary open-angle glaucoma. The approval was based on results of the COMPASS study.

That study demonstrated a statistically significant reduction in intraocular pressure 2 years after surgery in patients who underwent implantation with the stent at the time of cataract surgery, relative to patients who underwent cataract surgery alone.

At 2 years post surgery, there was little between-group difference in endothelial cell loss, and results were consistent with peer-review literature benchmarks of cataract-related endothelial cell loss.

The COMPASS-XT study collected safety data for an additional 3 years. Results at 5 years showed that patients treated with the CyPass stent experienced statistically significant endothelial cell loss compared to those who underwent cataract surgery alone.

"We believe that withdrawing the CyPass Micro-Stent from the market is in patients' best interest and is the right thing to do," Stephen Lane, MD, Alcon's chief medical officer, said in a statement.

"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-Stentin the future," said Lane.

Alcon said it will communicate directly with ophthalmic surgeons with recommendations for evaluating and managing those patients who have already received a CyPass Micro-Stent and with instructions for returning unused devices.

Providers in the United States may call 1-800-862-5266 for assistance with product returns. For medical information on the CyPass Micro-Stent, call 1-800-757-9785. To report product complaints or adverse events, the number is 1-800-757-9780. Providers outside the United States should contact their local Alcon representative, the company said.

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