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.
CyPass® Micro-Stent is a tiny tube that is implanted into the eye to help drain fluid that builds up in patients with glaucoma. The CyPass® System consists of a small stent (CyPass® Micro-Stent) that is pre-loaded into a stent delivery tool (CyPass® Applier).
How does it work? The CyPass® Micro-Stent is designed to control eye pressure (intraocular pressure, or IOP) by creating a drainage pathway from the inside (anterior chamber) to the outermost layer of the eye (suprachoroidal space).
When is it used? The CyPass® Micro-Stent is used in patients with primary open angle glaucoma (POAG). If not treated, pressure builds up inside the eye and eventually can damage the optic nerve, causing blindness. The CyPass® Micro-Stent is placed in the eye at the time of cataract surgery.
What will it accomplish? Data supporting the approval of this device included 374 subjects implanted with the CyPass® Micro-Stent device at the same time as cataract surgery, and 131 patients that had cataract surgery alone. In this study, 72.5 percent of patients who received the CyPass® Micro-Stent achieved a significant lowering of their IOP compared to 58 percent of patients who had cataract surgery alone. The lower IOP lasted through the 2-year-long study. Complications occurred in 39.3 percent of patients with CyPass® Micro-Stent and cataract surgery and in 35.9 percent of patients with cataract surgery alone.
When should it not be used? The CyPass® Micro-Stent should not be used if:
- patients have a type of glaucoma other than POAG.
- eye anatomy or condition is unusual.
The CyPass Micro-Stent is a prescription medical device that is indicated for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild to moderate primary open-angle glaucoma. The use of the CyPass Micro-Stent is contraindicated in eyes with angle closure glaucoma and eyes with traumatic, malignant, uveitic or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle. If IOP is not adequately maintained after implantation of a CyPass Micro-Stent, additional therapy may be needed for IOP control.
In a randomized, multicenter clinical trial comparing cataract surgery with CyPass to cataract surgery alone, the most common post-operative adverse events included: Best Corrected Visual Acuity (BCVA) loss of 10 or more letters at 3 months after surgery (8.8% for CyPass vs. 15.3% for cataract surgery only); anterior chamber cell and flare requiring steroid treatment 30 or more days after surgery (8.6% vs. 3.8%); worsening of visual field mean deviation by 2.5 or more decibels (6.7% vs. 9.9%); IOP increase of 10 or more mmHg 30 or more days after surgery (4.3% vs. 2.3%); and corneal edema 30 or more days after surgery, or severe in nature (3.5% vs. 1.5%). Please refer to the Instructions for Use for the CyPass Micro-Stent for a complete list of contraindications, warnings, precautions and adverse events.
Credit : Novartis