2 August 2016 - US FDA grants approval for CyPass Micro-Stent for sale in the US, expanding Alcon's surgical presence to treat glaucoma.

Alcon, the global leader in eye care and a division of Novartis, announced today that it has achieved FDA approval for the CyPass Micro-Stent, a micro invasive glaucoma surgical (MIGS) device to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery. CyPass Micro-Stent is the latest addition to Alcon's surgical portfolio providing an additional option to meet the needs of millions of glaucoma patients.

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).

The secondary effectiveness endpoint was also met, with 61% of patients in the CyPass study group achieving a target IOP (between 6 and 18 mmHg) at the 24-month postoperative examination without medication, which is a statistically significant difference.

Read Alcon press release