Alcon Withdraws CyPass Device over Endothelial Cell Loss

August 31, 2018: By Joan McKenna

Alcon has begun an immediate voluntary market withdrawal of its CyPass Micro-Stent worldwide due to endothelial cell loss (ECL), the Novartis subsidiary announced Aug. 29.

Patients followed for five years postoperatively experienced “statistically significant endothelial cell loss” compared with those who underwent cataract surgery alone, Alcon said. Severe ECL can lead to the need for a corneal transplant.

The CyPass is a minimally invasive glaucoma surgery device indicated for use with cataract surgery in patients with mild to moderate primary open-angle glaucoma. The CyPass is inserted into the supraciliary space to connect the anterior chamber to the suprachoroidal space. Proper insertion should advance the device so one retention ring and the collar are visible in the anterior chamber.

Some endothelial cell loss was reported in the CyPass’ pivotal COMPASS study, which compared treated patients (374) with those undergoing cataract surgery alone (131), but the company said outcomes were consistent with peer-reviewed literature benchmarks of cataract-related ECL.

ECL loss greater than 30 percent was noted in 9.6 percent (16/166) of subjects for whom one CyPass retention ring was reported visible at two or more postoperative exams. In subjects with two rings visible, ECL greater than 30 percent was noted in 9.8 percent (4/41) of subjects. The FDA label notes that positioning data was not reported for every subject, a confounding factor in determining a relationship between CyPass positioning and ECL.

Alcon said it would provide surgeons with recommendations for evaluating and managing patients with CyPass stents.

Chief Medical Officer 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 labeling changes that would support the reintroduction of the CyPass Micro-Stent in the future.”

Alcon purchased the CyPass technology in its acquisition of Transcend Medical in February 2016. The company launched the device in October 2016.

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