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College advice on withdrawal of CyPass Micro-Stent by Alcon

30 August 2018

Alcon announced on 29 August 2018 the withdrawal of a glaucoma drainage device or micro-stent called ‘CyPass’ due to concerns about long term effects on the corneal endothelial cell count in their latest 5-year study.

Whilst further guidance is expected from Alcon following consultation with the MHRA, the College is issuing the following advice to members in the interim.

As of now, the CyPass device should no longer be implanted.

The device has US Food and Drug Administration (FDA) approval since 2016 for use in conjunction with cataract surgery in adult patients with mild-to-moderate primary open-angle glaucoma based on a two-year COMPASS study. The 5-year COMPASS XT study showed that the CyPass group had “statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone”.

At this point there is no more detailed data and there has not been any suggestion that patients have suffered permanent corneal damage, lost vision or experienced other serious effects. In addition, it is not certain whether this may relate to all devices or to device position. Further uncertainties include whether it is appropriate or justified to remove devices already implanted, which carries risks, or what the exact long term risks are for patients.

It is likely that Alcon will communicate directly with ophthalmologists as to further information and advice following consultation with the regulators and we understand this will be within 2-3 weeks. It is possible that there may be media interest before this and, if the story appears, it may create concern amongst patients who have received this device, other micro-drainage devices, or even had more traditional tubes and trabeculectomies.

It is important that all ophthalmic units who see glaucoma patients with these devices or who undertake glaucoma surgery in general have a strategy to deal with affected patients and patient queries. The College would advise glaucoma consultants and clinical leads to work with their staff to set up a system to deal with queries, and proactively identify which devices their patients have received to be able to identify and consider how to manage CyPass patients; and to be able to advise patients which particular other implant or surgery they have received and be able to reassure them. Local Alcon representatives should be contacted for more details as and when available.