New Micro-Invasive Device Approved for Glaucoma

AUGUST 15, 2016
Krystle Vermes
The FDA has just approved a new micro-invasive surgical device to treat glaucoma.
 
Alcon’s CyPass Micro-Stent is indicated for patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery.
 
The device’s FDA approval was based on the results of the COMPASS trial, which enrolled more than 500 mild-to-moderate glaucoma patients undergoing cataract surgery. Approximately 73% of the CyPass Micro-Stent study group achieved a statistically significant decrease in intraocular pressure (IOP), and 61% also achieved a target IOP at their 24-month postoperative examination without medication.
 
In a press release, Alcon CEO Mike Ball explained that the CyPass Micro-Stent “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.”
 
The most common side effects associated with the device are:
·      Best corrected visual acuity loss of 10 or more letters at 3 months after surgery
·      Anterior chamber cell and flare requiring steroid treatment 30 or more days after surgery
·      Worsening of visual field mean deviation by 2.5 or more decibels
·      IOP increase of 10 or more mmHg 30 or more days after surgery
·      Corneal edema 30 or more days after surgery

More than 60 million individuals around the world have glaucoma, which can lead to optic nerve damage. IOP is the only known modifiable risk factor of the disease.


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