Perspective

Alcon calls for surgeons to stop implanting CyPass micro-stent

Citing “uncompromising commitment to patient safety,” Alcon has announced an immediate, voluntary withdrawal of all versions of the CyPass micro-stent from the global market and advises surgeons to immediately cease further implantation of the device.

According to a company press release, the decision was based on safety data from the COMPASS-XT study, which found a statistically significant difference in endothelial cell loss at 5 years after surgery in patients who received the device in conjunction with cataract surgery compared to those who underwent cataract surgery alone.

The CyPass micro-stent has been FDA approved for use in conjunction with cataract surgery for treatment of mild-to-moderate primary open-angle glaucoma since July 2016. That approval was based on 2-year results of the COMPASS study, which “were consistent with peer-review literature benchmarks of cataract-related endothelial cell loss,” according to the release.

The company will contact ophthalmic surgeons directly with recommendations how to proceed, according to the release.

"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," Stephen Lane, MD, chief medical officer for Alcon, said.

 

Citing “uncompromising commitment to patient safety,” Alcon has announced an immediate, voluntary withdrawal of all versions of the CyPass micro-stent from the global market and advises surgeons to immediately cease further implantation of the device.

According to a company press release, the decision was based on safety data from the COMPASS-XT study, which found a statistically significant difference in endothelial cell loss at 5 years after surgery in patients who received the device in conjunction with cataract surgery compared to those who underwent cataract surgery alone.

The CyPass micro-stent has been FDA approved for use in conjunction with cataract surgery for treatment of mild-to-moderate primary open-angle glaucoma since July 2016. That approval was based on 2-year results of the COMPASS study, which “were consistent with peer-review literature benchmarks of cataract-related endothelial cell loss,” according to the release.

The company will contact ophthalmic surgeons directly with recommendations how to proceed, according to the release.

"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," Stephen Lane, MD, chief medical officer for Alcon, said.

 

    Perspective
    Inder Paul Singh

    Inder Paul Singh

    Like many of you, as an adopter of multiple MIGS procedures in my practice, I woke up this morning with a big shock hearing the news of the CyPass micro-stent being voluntarily withdrawn from the market. I admit, at first, I was not only shocked but frustrated and concerned since I have observed the clinical benefits of the CyPass in many of my patients who have needed better control of their IOP and/or potential for reducing the drop burden. I have relied on the CyPass to help in situations when I felt it was the best option for my patient. I have seen the overall high safety performance as well, so to hear that it was being withdrawn for concerns about endothelial cell loss was a surprise, since in my experience, the benefits have far outweighed the risks. But, patient safety is, and should always be, our number one priority and concern, which is also a hallmark of the MIGS space. I do applaud Alcon for doing the right thing by withdrawing CyPass, to allow for a better understanding of the clinical impact of this endothelial cell loss finding. It is important to note the FDA did not mandate this; rather, Alcon was being proactive with patient safety in mind. Not only is it better for patient safety but will allow us as surgeons to better understand the variables that might be contributing to this finding, such as placement of the device, material, and flow dynamics. Based on preliminary data from the COMPASS-XT 5-year follow-up, it does appear that length of the CyPass in the anterior chamber does correlate with rate of endothelial cell loss. This does make clinical sense since we see the same correlation in traditional tubes shunts. I have seen corneal endothelial cell changes from placement of tubes too close the endothelium or left too long in the eye. As the data are further studied, I believe we will have a better handle on the risk factors. Regardless of this voluntary withdrawal, it is important to recognize every procedure has potential risks, and our definition of “safe” depends on the risk/benefit relationship. CyPass implantation is a safe procedure in my opinion. I do also think the CyPass will reemerge in the future, with possibly an updated labeling and/or possible updated training for surgeons. Treating glaucoma is not easy, so having an option like the CyPass is much needed.

    • Inder Paul Singh, MD
    • Racine, Wisconsin

    Disclosures: Singh reports financial relationships with Aerie, Alcon, Allergan, Bausch + Lomb, Ellex, Glaukos, Ivantis, Senju and Sun.