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Safety concerns prompt immediate recall of MIGS device

05/09/2018By Matthew Woodley
Alcon has announced the immediate, voluntary recall of its CyPass Micro-Stent, after a five-year postoperative clinical study found it may cause damage to the eye.

Surgeons have been advised to immediately stop implanting the minimally invasive glaucoma surgery (MIGS) device and to return any unused devices to Alcon. The recall was based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study, which found the CyPass Micro-Stent group experienced statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone.

The recall applies to all variants of the CyPass Micro-Stent product and the company has indicated it will communicate directly with eye surgeons with recommendations for managing and evaluating patients who have been implanted with the MIGS device.

“We believe that withdrawing the CyPass Micro-Stent from the market is in patients’ best interest and is the right thing to do.”
Stephen Lane, Alcon.

“We believe that withdrawing the CyPass Micro-Stent from the market is in patients’ best interest and is the right thing to do,” chief medical officer Dr Stephen Lane said.

“Although we are removing the product from the market now out of an abundance of caution, we intend to partner with the FDA and other regulators to explore labelling changes that would support the reintroduction of the CyPass Micro-Stent in the future.”

The TGA approved the use of the CyPass for adults with mild-to-moderate primary open-angle glaucoma in conjunction with cataract surgery in February. The approval was based on the results of the two-year COMPASS study, which demonstrated a statistically significant reduction in intraocular pressure at two years post-surgery, with little difference in endothelial cell loss between the CyPass and cataract surgery-only control groups.

According to Reuters, Alcon’s parent company, Novartis, has said the setback will not affect plans to spin off the unit next year. While Novartis’ shares fell in the immediate aftermath of the announcement, at least one analyst has said the company’s swift reaction should help keep it out of the crosshairs of lawyers.

However, it could still be a blow to the Swiss drugmaker, as Alcon had touted the stent’s contribution to recovering sales as recently as July. The company said a double-digit percentage increase in implantables, including the CyPass, had contributed to an 8% surge in revenue from its surgical devices to US$1.03 billion (AU$1.42 b).

Designs for Vision

Despite this, a Novartis spokesperson told Reuters that the CyPass sales were “immaterial” to Alcon’s total first half sales and that it would not impact its target of mid-single-digit percentage sales increases in constant currencies for the year.

Carl Zeiss

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