August 29—the day that the CyPass supraciliary stent (Alcon) was voluntarily withdrawn from the market because of safety data on endothelial cell loss—was a “day that really shocked the glaucoma world,” said Thomas W. Samuelson, MD, during Glaucoma Subspecialty Day.
In presenting an overview of where we are now, Dr. Samuelson said, “My opinion is that the process is working quite nicely . . . basically, the FDA placed a safety net, Alcon has acted swiftly and responsibly, and the entire process has been very transparent.”
Stay tuned, and focus on patient safety. “We don’t know where this plot is going,” Dr. Samuelson said. “We don’t know the 7- or 10-year data” on safety.
Take a deep breath, and consult the guidelines. The CyPass withdrawal is a Class 1 recall, “which is a very serious recall, and we have to take it seriously,” Dr. Samuelson said.
Some glaucoma specialists have pushed back against the FDA’s decision, he noted, arguing that because glaucoma is a potentially blinding condition, some risk is justified. Moreover, they note that other interventions have risks as well.
Preliminary guidelines were issued by the American Society of Cataract and Refractive Surgery (ASCRS), and the FDA released an updated safety statement earlier this week.1 Among other points, the ASCRS guidelines recommend gonioscopy, documentation of the position of the device, and monitoring of all patients on an ongoing basis. Overall, glaucoma specialists should “take a deep breath,” he said. “We really know what to do.”
Patients with 2 or more rings showing on gonioscopy are considered to be at greatest risk of corneal decompensation. “Deeper implantation could be considered in the early postoperative period. Removal is not favored; trimming can be considered,” Dr. Samuelson said.—Jean Shaw
1 www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm624283. Accessed Oct. 27, 2018.
Financial disclosures. AcuMems: C; Aerie Pharmaceuticals: C; Akorn: C; Alcon: C; AMO: C; AqueSys/Allergan: C,O; Bausch+Lomb/Valeant: C; Belkin Laser: C; Endo Optiks: C; Equinox: C,O; Glaukos: C,O; Ivantis: C,O; Ocular Surgery News: C; Santen: C; Shire: C; Transcend Medical: C; Vindico/Slack: C.
Disclosure key. C = Consultant/Advisor; E = Employee; L = Speakers bureau; O = Equity owner; P = Patents/Royalty; S = Grant support.
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