How did the withdrawal of the CyPass affect your patients and practice?
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No current device replaces CyPass
The withdrawal of the CyPass (Alcon) removed the one drainage device that shunted fluid to the suprachoroidal space, and it has not been replaced to date. This mechanism was unique and provided a significant benefit for many patients with uncontrolled IOP. Corneal endothelial health is important, and the safety data elucidating the long-term risk in some patients should not be discounted. In my opinion, solely as a practitioner and not as a regulatory specialist, I would have preferred for the new safety data to result in greater education regarding proper positioning of the device and a recommendation for use in later-stage disease.
We routinely use implants that have the potential to affect corneal health, such as traditional glaucoma drainage devices including tube shunts and the Ex-Press device (Alcon). Additionally, we have successful and less invasive ways to replace or transplant the corneal endothelium if a patient has a functional deficit. At this point, we have no way of replacing the retinal ganglion cells if they die from uncontrolled IOP.
Douglas J. Rhee, MD, is an OSN Glaucoma Board Member.
Be critical, cautious with new technology
The withdrawal of CyPass (Alcon) had a significant influence on how we treat our patients. With glaucoma, there has always been a movement to be more proactive when it comes to managing our patient’s pressures so we can preserve a healthy optic nerve.
The difficulty that we ran into with CyPass was that it was an approved procedure. Most of us got good results, but the subsequent withdrawal left us in a precarious position. We had to have discussions with our patients about a procedure that we had done that then had some issues, and the device was eventually taken off the shelves.
The withdrawal made us much more cautious with any new innovation that we want to use in our practice. It was also hard because there was a good niche for this device in our patients. It was better in terms of benefits relative to trabeculectomy and better with regard to risk. But with its removal, we lost the opportunity to use it.
When it comes to assessing innovation, we want to be critical about where we use it. With the CyPass, it fell under the same setting as a trabecular bypass stent procedure indication vs. an iStent (Glaukos) or a Hydrus (Ivantis) procedure. It had more inherent risk because it was in the suprachoroidal space, and subsequent endothelial cell loss damage was found. So, we want to be cautious with innovative devices and how we use them in our patients to make sure we truly assess the risk-benefit ratio. That way we can position the devices and use them with the right patients.
We want to be cautious when new technology comes out, especially when the indications are the same but their inherent risks are a little bit different. We want to make sure we do a better job of stratifying our patients so the risks of the procedure match the benefits of the procedure as well.
Savak “Sev” Teymoorian, MD, MBA, is an OSN Glaucoma Board Member.