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

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...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Source Type: news