Alcon, a specialist in eye care and a division of Novartis, has achieved FDA approval for the CyPass Micro-Stent, a micro invasive glaucoma surgical (MIGS) device.
The treatment is intended for 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 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."
Acquired in February 2016 by Alcon, Transcend Medical developed the CyPass Micro-Stent to treat mild to moderate primary open-angle glaucoma.
The MIGS device is implanted just below the surface of the eye in conjunction with cataract surgery.
It is designed to treat less severe glaucoma by enhancing part of the natural drainage pathways of the eye with minimal tissue disruption.
This allows the excess fluid in the eye to drain with the goal of reducing intraocular pressure levels.