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Alcon Achieves US Approval for CyPass Micro-Stent MIGS Device

Update on CyPass Micro-Stent: On August 29, 2018, Alcon announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market and advised surgeons to immediately cease further implantation with the CyPass Micro-Stent. Alcon's decision and corresponding recommendation was based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study. At five years, the CyPass Micro-Stent group experienced statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone. For more information, please read the Novartis press release.

The original news article follows below:

Alcon has achieved United States FDA approval for the CyPass® Micro-Stent, a micro-invasive surgical device to treat glaucoma.

Alcon (a division of Novartis) announced today that the US Food and Drug Administration (FDA) has granted approval for its CyPass Micro-Stent for sale in the United States, expanding Alcon's surgical glaucoma treatment options. The CyPass Micro-Stent is a micro invasive glaucoma surgical (MIGS) device to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery.

The FDA approval is based on the landmark COMPASS Study, the largest MIGS study to date with a two-year follow-up for over 500 mild to moderate glaucoma patients undergoing cataract surgery. The primary effectiveness endpoint was met, with 73% in the CyPass Micro-Stent study group achieving a statistically significant decrease (>= 20%) in intraocular pressure (IOP).

Source: GlobeNewswire

Last reviewed on August 29, 2018

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