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.
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.
"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.
“Implanted using a non-perforating ab interno approach, this device is placed at the base of the scleral spur and slides nicely into the subconjunctival space,” said Steven D. Vold, MD. “For surgeons...who have not done a lot of angle surgery, the CyPass might be a good alternative.”
Dr. Vold, who is in private practice in Fayetteville, AR, is a consultant to Transcend Medical and Alcon Laboratories.
The device is contraindicated in eyes with angle closure glaucoma and eyes with traumatic, malignant, uveitis, neovascular glaucoma, and eyes with discernible congenital anomalies of the anterior chamber angle.
The randomized clinical trial compared patients with cataract surgery paired with the device to patients in a cataract surgery group.
Common post-operative adverse events included:
- Loss of BCVA of 10 or more letters at 3 months after surgery (8.8% for the device group and 15.3% for cataract surgery group)
- Anterior chamber cell and flare requiring steroid treatment 30 or more days after surgery (8.6% vs. 3.8%)
- Worsening visual field mean deviation by 2.5 or more decibels (6.7% vs. 9.9%)
- IOP increase of 10 or more mm Hg 30 or more days after surgery (4.3% vs. 2.3%)
- Corneal edema 30 or more days after surgery or severe in nature (3.5% vs. 1.5%)
Complications occurred in 39.3% of patients in the device group and 35.9% in the cataract surgery group, according to the FDA.
Alcon acquired Transcend Medical, developer of the micro-stent, in February 2016.