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Alcon Pulls CyPass Micro-Stent from Market Based on Long-Term Safety

Alcon Pulls CyPass Micro-Stent from Market Based on Long-Term Safety
Removing the CyPass Micro-Stent from the market is in patients' best interests, and is "the right thing to do," said Alcon's chief medical officer, after five-year data revealed a higher rate of cell loss compared to patients who had cataract surgery alone.

One company's loss is another company's gain today in the increasingly competitive microinvasive glaucoma surgical (MIGS) market. 

Alcon, a division of Novartis, said it is voluntarily removing all versions of the Cypass Micro-Stent from the global market based on a new analysis of five-year post-surgery data. The COMPASS-XT long-term safety data showed that at five years, patients in the CyPass Micro-Stent group experienced statistically significant endothelial cell loss compared to patients who underwent cataract surgery alone.

The news sent shares of Glaukos, one of the main competitors in the MIGS space, soaring today. Glaukos' stock was trading at about $61 a share at midday, up 36.16% ($16.20), and reached as high as $70 a share in morning trading. FDA approved Glaukos' iStent inject Trabecular Micro-Bypass System in June. Another competitor, Ivantis, received FDA approval earlier this month for its Hydrus Microstent.

FDA approved the CyPass Micro-Stent in July 2016 for use in conjunction with cataract surgery in adult patients with mild-to-moderate primary open-angle glaucoma based on the results of the landmark two-year COMPASS study, which demonstrated a statistically significant reduction in intraocular pressure at two years post-surgery in patients implanted with the CyPass Micro-Stent at the time of cataract surgery, compared to patients who just had cataract surgery.

At two years post-surgery, there was little difference in endothelial cell loss between the two groups, the company noted, but the study was designed to follow patients for an additional three years, with analysis at the five-year mark. That's where the difference in cell loss was revealed.

Novartis acquired the device for its Alcon business in early 2016 when the company bought Transcend Medical.

"We believe that withdrawing the CyPass Micro-Stent from the market is in patients' best interest and is the right thing to do," said Stephen Lane, MD, Alcon's chief medical officer. "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 labeling changes that would support the reintroduction of the CyPass Micro-Stent in the future."

Alcon said it will communicate directly with ophthalmic surgeons about how to manage patients who have already received a CyPass Micro-Stent, and instructions for returning unused devices.

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