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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).
Last reviewed on August 03, 2016