November 9, 2020
Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Nina Zeldes, a senior fellow at the center. Our center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have no conflicts of interest.
Today, the committee is asked to assess whether the benefits of the VisAbility Micro Insert System outweigh the risks.
It is important to note that the FDA has rejected this application twice already, deeming it “not approvable” because of continued concerns about the benefit-risk assessment. There remain substantial concerns about the safety of the device, especially since there are very safe alternatives for people with this condition. One notable issue is that the trial did not have pre-specified primary safety endpoints. As FDA mentioned in the executive summary, there are concerns of scleral perforations and anterior segment ischemia, which can lead to potential loss of vision or loss of the eye. The data also show that at least 47% of patients experienced adverse events, sometimes lasting years, as was the case for AEs such as temporal iris atrophy and subconjunctival hemorrhages.
Additionally, there were also safety concerns about the implantation procedure, in a trial where those performing the procedure were specially trained in implantation for the trial. Despite that training, 4% of patients experienced surgical complications related to the implantation procedure. These risks will only be magnified when anyone, not just those specially trained for the trial, will be able to perform the procedure.
As we all know, there are easily available and often inexpensive alternatives for treatment of presbyopia, such as glasses or contacts. Although the device in question potentially eliminates the need for these other options, there are notable risks, and the studies have not followed patients for a long-enough time to determine long-term risks. After all, this is a device that requires cutting both eyes and inserting implants. Although the proposed indication is for those ages 45 to 60, if it is on the market it would no doubt be eventually implanted in those much older. So, there is no good reason to not include other patients, as well as demographically diverse patients.
The bottom line, as FDA highlighted in their executive summary, the risks for this device are notable. Especially considering that it is unnecessary because other, non-invasive and approved treatments are available. We urge the committee to focus on the lack of confidence of whether safety outweighs the risks.