This week Alcon announced the withdrawal of all versions of the CyPass Micro-Stent from the worldwide market. The move was made after the company analyzed five-year data from the COMPASS-XT long-term safety study. The product was approved by FDA two years ago for use with cataract surgery in adult patients with mild-to-moderate primary open-angle glaucoma. The agency’s approval was based on results of the two-year COMPASS study.
The COMPASS-XT study collected safety data on the subjects who participated in the COMPASS study for three more years, generating five years of post-surgery data. However, at five years, the group who had the CyPass Micro-Stent had “statistically significant endothelial cell loss” compared to the group who only had cataract surgery, according to an Alcon release.
Alcon’s Chief Medical Officer Stephen Lane, M.D. called the product’s market withdrawal “the right thing to do”. However, he also stated, “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 is advising ophthalmic surgeons to immediately stop implanting the devices and to return unused devices to the company.