What’s next for vision prosthesis?
A summary of the 2-day FDA public workshop on implants for vision restoration
It’s the article that rocked the bioelectronic medicine movement. “Their Bionic Eyes are Now Obsolete and Unsupported” was published by IEEE Spectrum in February 2022. The feature highlighted the many people who were left without support for their implanted devices after Second Sight, the company that offered the devices, closed their doors. The story brought a new spotlight to a long-standing problem. People left with implanted medical devices without support is not a new problem. We’ve experienced it in the past with DBS (deep brain stimulation) trials for mental health conditions, the closing of NeuroControl leaving people “paralyzed again”, and even BCI (brain computer interfaces) with the demise of Cyberkinetics. What has changed is the number of people living with implanted devices has grown significantly over the last decade since the inception of the BRAIN initiative in 2013. It is now at a point that the issue can no longer be swept under the rug but tackled with a collaborative approach.
This was the motivation for the 2-day public workshop hosted by the FDA and the University of Pittsburgh entitled “Expediting Innovation of Bioelectronic Implants for Vision Restoration.” It was a virtual meeting of the many stakeholders involved in the development, deployment, and support of these devices including people living with blindness. Within the context of safety and effectiveness, no stone was left unturned and no topic was left off the table. The workshop was designed to begin to address the unique challenges, considerations and technicalogical hurdles in the development and assessment of bioelectronic implants for visual restoration. Most importantly, the voice of people with lived experience was not just one panel discussion but peppered throughout the sessions to remind the attendees about the breadth of the community they seek to serve.
According to the background references, over one million people in the U.S. live with blindness and by 2050 that is projected to grow to 4 million. Moreover, the leading causes of blindness are inherited and age-related retinal diseases. The cost of these conditions isnot only rooted in the direct medical costs but the indirect costs like inform al care or assistive technology devices, as well as the costs of well-being and lost productivity. The latter two are the main drivers of socioeconomic impact. This translates to an overall burden of over $40 billion in the U.S.
The event was kicked off by Malvina Eydelman, Director of the Division of Opthalmology and Ear, Nose, and Throat Devices. The session agenda was moderated by Tieuvi Nguyen, Director of the Division of Ophthalmic Devices at CDRH. Sessions were segmented into topic areas of public health impact, technology & regulation, evaluation of safety and effectiveness, clinical outcome assessments and patient preferences, as well as post-market considerations. The technology sessions highlighted the device developments in research and commercial implants including the variety of modalities from retinal implants to cortical applications. With these technical advances more conditions related to blindness can now be addressed. The current regulatory pathways and guidances were also presented. There was a session about ethical considerations, by Joe Fins from the Weill Cornell School of Medicine. His case is that there are common challenges around all bioelectronic implanted devices. There are potential remedies to the common issues, which differ from drug development. Principles such as non-abandonment, the value of longitudinal obligations, and covenants in consent, decision-making, and aftercare plans are all areas to be addressed before they stymy research and development.
The highlight of Day 1 was the panel discussion of people with lived experience providing the “Patient Perspectives”. Seven panelists are all living with blindness, and some have experience with implanted devices. Some are veterans, some are athletes, while others are actively working and some in retirement, but all panelists had their voice in advocacy. Moderated by Eva Rorer from the FDA, the panelists described what it was like to live with blindness and the personal impact it can have like the loss of independence, feelings of depression and isolation. They even talked about the nuances of vision loss like the difficulty of picking out what to wear, bumping into people and objects, and the commonality of falls. Some express hesitancy toward medical implants because of concerns around losing residual vision, the risks of surgery, and the need to clarify the tangible benefits. One panelist, Jacob, was diagnosed with Ushers Syndrome at the age of 7 and lives with hearing and vision loss. He was implanted with a cochlear implant at a young age and talked about how he learned to adapt with the technology. Still he expressed hesitancy toward visual implants due to the loss of residual vision and the potential financial burden. Three of the panelists have artificial vision implanted devices; a retinal implant, cortical implant and an implanted retinal telescope. They each talked positively about their personal experiences and found the technology not to completely restore their vision but to give them an “extra layer for navigating the world” told by Jason who lives in southern California and had moved from his native home in South Africa to participate in a clinical trial. Their messages resonated hope, independence, and the respect of diverse perspectives.
The second day also had some presentation sessions but the real attraction was the two panel discussions. One was on the topic of clinical outcome assessments and patient preferences moderated by Michelle Tarver, the Deputy Director of the Office of Strategic Partnerships and Technology Innovation as well as the Director of Patient Science and Engagement. The second panel was moderated by Michael Repka, Vice Chair of the Wilmer Eye Institute at Johns Hopkins Children's Center in Maryland, with the discussion topic of post-approval considerations.
The first panel led by Dr. Tarver had a diverse presence including a person living with blindness, a representative from a foundation, and representatives from FDA with experience in health economics, outcomes assessments, and patient engagement. The discussions revolved around the variety of methods that can be used to measure lived experience preferences and how the outcomes can be applied to clinical assessments, including quality of life measures. The topic of including patients as advisors touched on the challenges of finding the right people and the need to seek diversity in representation. In the end, choosing the right outcome measures and assessing risk-benefit evaluations needs to be a collaborative effort with the community of people living with the condition.
The second panel included two people with blindness and both with experience as participants in a device clinical trial; Paul was part of the Argus II trial and Richard is currently in the Orion trial. The panel also consisted of clinicians from the Willmard Eye Institute and from Walter Reed National Military Medical Center, as well as representatives from FDA, the American Academy of Ophthalmology, and from industry. There was a key discussion around informed consent. Both Paul and Richard felt like they were well informed prior to their surgical implants but neither felt prepared for the long-term implications that they may face. Dr. Collins stressed that 30-page consent forms are difficult for people who are living with blindness. She also proposed that informed consent should no longer be a one-time occurrence but an on-going discussion as knowledge evolves with the clinical trial. Lloyd Diamond, CEO of Pixium Vision, added that among the 50 participants in their clinical trials, the three most consistent comments around consent are related to managing expectations, the burden of participation, and the ergonomics and aesthetics of the device. Both Drs. Loyo-Barrios and Lum spoke about the importance of post-market approval of Real World Evidence. The American Academy of Opthalmology administers the IRIS registry which tracks over 450 million clinician visits using electronic health records to follow the patient from practice to practice. This panel discussion also turned to the topic of device obsolescence. Dr. Roy who was involved in the Argus II development stressed that the device did not fail, the company did. “The risk of [novel] technology is taken on by small companies and start-ups,” and he went on to say, “We should not make the process onerous on these start-ups.” In many cases, small companies are taking the risk to bring new technologies into the clinic when it should be a collective effort. Dr. Zrenner, who was involved with the Alpha IMS clinical trial, mentioned that at the end of the trial they had 70 participants with implants. They made a contract with each clinical center to care for the participants after the end of the trial. Overall, the panelists noted that we need to continue to make progress, apply what we learned, bring new practices forward, keep applying scientific rigger, and not become a burden for technology advancements. From Richard’s perspective, “the technology is in the embryonic stages.”
Here are some takeaways from this pubic workshop:
- Relative to the prevalence of blindness, the research investment is muted compared to other neurological conditions such as Parkinson’s disease.
- There is a need to establish ethical principles of non-abandonment, affirming rights and post-care plans for implanted devices.
- The devices need to be put in the context of what they can actually achieve, which is artificial vision. Vision restoration is not accurate and can cause unrealistic expectations.
- The diversity of perspectives is a critical element of device development.
- Conversations with condition-based groups and the researchers help to formulate what is meaningful related to a specific technology, as well as identify the attributes that are most important to those with lived experience.
- Informed consents need to change from a single incident to an on-going conversation.
- This effort requires a collaborative community approach to tackle the challenges, fill the gaps and spark innovation not only in technology design, but the entire process from lab to every day use.
There is no easy fix to this issue. I hope this will spark action on the part of policy, practices and ecosystems for bringing new neurotechnologies to the people for whom they were intended.
“Past failures and challenges should be taken to heart to pave the way to a better wave of prosthetics.” — Dr. Malvina Eydelman, MD
Transcripts and recordings of the event will be available on the FDA website. The docket (FDA-2022-N-1542) will remain open for public comment until November 22. A manuscript on this workshop will be published. The event website can be found here: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/co-sponsored-public-workshop-expediting-innovation-bioelectronic-implants-vision-restoration#references
An additional note: Second Sight, NeuroControl, Cyberkinetics mentioned at the beginning of this article. Second Sight Medical Products completed a merger with Nano Precision Medical to create a new company called Vivani Medical, Inc. They are servings those users of their technologies. NeuroControl Corporation once offered the Freehand, a neural prosthesis designed to provide hand function for people living with paralysis. The company went out of business in 2001. After several years of negotiations, the patents returned to Case Western Reserve University. Cyberkinetics Neurotechnology Systems was developing a first-of-a-kind, brain computer interface in the early 2000s called the BrainGate. The company went public but later disbanded and the assets were sold to privately-held Braingate, Inc. Eventually, the technology was acquired by Blackrock Microsystems which is in service today developing new BCIs and building a community of early BCI users.
