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The system works: Withdrawal of CyPass from the market
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CHICAGO — The voluntary withdrawal of CyPass from the global market shocked the field of ophthalmology, but the process in place worked nicely to approve the device and, in turn, take it off the market, according to a speaker here.
In August, Alcon issued a voluntary withdrawal of the MIGS device, citing risk for endothelial cell loss, and the FDA has subsequently identified the recall as being Class I.
“A subclinical finding was identified before clinical signs or symptoms were evident. The FDA placed a safety net and Alcon has acted swiftly and responsibly. The entire process has been very transparent,” Thomas W. Samuelson, MD, said at Glaucoma Subspecialty Day preceding the American Academy of Ophthalmology meeting.
The CyPass micro-stent had been approved by the FDA after 2 years of safety and efficacy data, but required 5-year data, primarily for safety, and the COMPASS-XT trial was initiated.
“We don’t know where this plot is going. We don’t know the 7-year data, or the 10-year data. We have plenty of patients who have achieved at least 8 years after CyPass and we haven’t seen corneal decompensation in anyone, and that’s very reassuring,” he said.
For patients who already have a CyPass implanted, the American Society of Cataract and Refractive Surgery created a combined task forced to craft a guidance document, he said.
“With three rings showing, patients have more risk. With one ring or less, it’s considerably less risk. All patients should be monitored. Specular microscopy should be considered for those at increased risk, especially if they have two or more rings visible, or if the lumen is above Schwalbe’s line,” Samuelson said.
Deeper implantation can be considered if a stent is not adequately implanted, but only if it is very early in the postoperative period. Removal of the CyPass is not favored by the ASCRS task force, but trimming can be considered for patients at high risk.
“The FDA called this a Class I recall, which is a very serious recall and we have to take it seriously. One of the major issues of discussion is who should get endothelial cell specular microscopy? Personally, I’m doing it in patients at higher risk and observing patients at lower risk,” he said.
Samuelson said that he was hopeful that Alcon will partner with the FDA to bring the surgical tool back to the market or agree on a more suitable patient population. – by Robert Linnehan
References:
Samuelson TW. CyPass withdrawal: Perspective and review of preliminary guidance document. Presented at: AAO Subspecialty Day; Oct. 26-27, 2018; Chicago.
FDA Class 1 device recall CyPass MicroStent. https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm624282.htm.
Disclosure: Samuelson reports he is a consultant for Alcon.