Alcon Announces Voluntary Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

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BASEL, Switzerland—Alcon on Wednesday announced an “immediate, voluntary market withdrawal” of the CyPass Micro-Stent from the global market. The company said the decision is based, in part, on its “uncompromising commitment to patient safety.” In addition, Alcon advised surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. “This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study,” the announcement noted. Alcon, the eyecare unit of Novartis, is expected to become an independent publicly traded company after a spinoff by its corporate parent in early 2019, as VMAIL has reported.

The Food and Drug Administration (FDA) approved the CyPass Micro-Stent in July 2016 for use in conjunction with cataract surgery in adult patients with mild-to-moderate primary open-angle glaucoma based on the results of the landmark two-year COMPASS study, according to the announcement.

“We believe that withdrawing the CyPass Micro-Stent from the market is in patients’ best interest and is the right thing to do,” Dr. Stephen Lane, Alcon’s chief medical officer, said in the announcement. “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.”

This voluntary market withdrawal applies to all versions of the CyPass Micro-Stent, Alcon said, and the company noted that it will communicate directly with ophthalmic surgeons with recommendations for evaluating and managing those patients who have already received a CyPass Micro-Stent, and instructions for returning unused devices.

In addition, Alcon provided the following contact information for U.S. customers:
• Customer services, for assistance with product returns — (800) 862-5266
• Medical information, for medical information on the CyPass Micro-Stent – (800) 757-9785
• Medical safety, to report product complaints or adverse events – (800) 757-9780
Customers located outside the U.S. should contact their local Alcon representative, the company noted.