Alcon pulls eye micro-stent from market after new 5-year safety data

Novartis headquarters
The voluntary product withdrawal comes after Novartis announced plans to spin off Alcon into a separate company. (Wikimedia Commons/Andrew/Flickr)

Novartis’ Alcon eye care division has withdrawn all versions of its CyPass micro-stent from the global market following new data from a long-term safety study. Used to relieve pressure under the eye following cataract surgeries for glaucoma patients, the company advised surgeons to stop implantations and return any unused devices.

The CyPass stent was first approved by the FDA in July 2016 after a two-year clinical study showed statistically significant reductions in intraocular pressure following the procedure compared to patients undergoing cataract surgery alone.

However, the extended, postmarket safety study showed that after five years, patients lost more endothelial cells—the cells lining the inner surface of the cornea, helping to maintain transparency—which was not seen at the two-year mark.

Webinar

How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDC

CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management.

"We believe that withdrawing the CyPass Micro-Stent from the market is in patients' best interest and is the right thing to do," Stephen Lane, Alcon’s chief medical officer, said in a statement. Alcon first acquired the CyPass stent from Transcend Medical in February 2016.

RELATED: Novartis announces widely expected Alcon spinoff, plus $5B share buyback, to strengthen focus on biopharma

The CyPass micro-stent (in gold)
being implanted under the eye.
(Image: Transcend Medical)

Novartis previously announced plans to spin off Alcon in the first half of next year, with the new separately traded company being based in Switzerland and its current home base of Fort Worth, Texas, serving as a “critical location,” according to CEO Vas Narasimhan.

Novartis’ stock price seemed to weather the news, dipping only 2% compared to the previous day.

"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," said Lane. Alcon also said it will help surgeons with managing patients that have already received the stent.

Suggested Articles

Sanofi will look to pull back from its three-year-old relationship with Verily and their virtual diabetes clinic, Onduo.

NASH leaders weigh in on the need for a drug for the disease and the challenges in getting it to patients.

AstraZeneca is linking up with DeepMatter, a big data firm focused on achieving reproducibility in chemistry, to help improve its compound synthesis.