Microstent approval makes big news in glaucoma world
Clinicians will soon have another treatment option for their patients with non-severe primary open-angle glaucoma (POAG). A micro invasive glaucoma surgical (MIGS) device (CyPass Micro-Stent, Alcon) has been approved by the FDA for use in patients with mild-moderate PAOG in conjunction with cataract surgery.
Clinicians will soon have another treatment option for their patients with non-severe primary open-angle glaucoma (POAG). A micro invasive glaucoma surgical (MIGS) device (CyPass Micro-Stent, Alcon) has been approved by the FDA for use in patients with mild-moderate PAOG in conjunction with cataract surgery.
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The approval was based on the COMPASS Study which included a two-year follow up for 500 mild-moderate glaucoma patients undergoing cataract surgery. The device reached its primary endpoint in that 73% of those with the implant had at least a 20% reduction in IOP, a statistically significant difference.
The secondary effectiveness endpoint was also met in that 61% of patients in the device group achieved an IOP between 6 and 18 mm Hg at the 24-month postoperative examination without the use of medication. This was also a statistically significant difference.
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"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, chief executive officer, 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."
The device is designed to work by enhancing the eye’s natural drainage pathways while only minimally disrupting the tissue.
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