August 29, 2018 / 5:14 AM / 3 months ago

Novartis eye care unit Alcon withdraws glaucoma stent

ZURICH, Aug 29 (Reuters) - Novartis eye care unit Alcon is voluntarily withdrawing its CyPass Micro-Stent after follow-up clinical data showed patients using the product experienced statistically significant endothelial cell loss compared with those who underwent cataract surgery alone.

Alcon, which the Swiss drugmaker plans to spin off to shareholders early next year, advised surgeons treating glaucoma patients to stop implanting the stents immediately, the company said in a statement on Wednesday.

The U.S. Food and Drug Administration had 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. (Reporting by Michael Shields)

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