Alcon achieves US approval for CyPass® Micro-Stent, a micro invasive surgical device to treat glaucoma

Novartis International AG / Alcon achieves US approval for CyPass® Micro-Stent, a micro invasive surgical device to treat glaucoma . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• US Food and Drug Administration (FDA) grants approval for CyPass Micro-Stent for sale in the US, expanding Alcon's surgical presence to treat glaucoma
   

The CyPass Micro-Stent is designed to reduce intraocular pressure in patients with mild to moderate primary open-angle glaucoma  
 

More than 60 million people worldwide are affected by glaucoma which may lead to progressive vision loss[1],[2]

Basel, August 2, 2016 - 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.   

"We are pleased by the FDA's decision to approve our CyPass Micro-Stent which establishes Alcon's presence in this emerging surgical category to treat mild to moderate glaucoma," said Mike Ball, CEO of Alcon. "It will provide a less invasive means of lowering IOP than traditional glaucoma surgery, with the goal of lowering the patient's dependence on topical glaucoma medication. We are excited to offer this new option to surgeons and the patients they serve."