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  5. Co-sponsored Public Workshop - Expediting Innovation of Bioelectronic Implants for Vision Restoration - 10/24/2022
  1. Workshops & Conferences (Medical Devices)

Workshop

Event Title
Co-sponsored Public Workshop - Expediting Innovation of Bioelectronic Implants for Vision Restoration
October 24 - 25, 2022

Date:
October 24 - 25, 2022
Time:
8:30 AM - 3:30 PM ET
Image
Illustration of an eye with blue lines surrounding it

SUMMARY

The Food and Drug Administration (FDA) is announcing a co-sponsored public workshop with the University of Pittsburgh entitled, "Expediting Innovation of Bioelectronic Implants for Vision Restoration." The purpose of this workshop is to provide a forum for all stakeholders, including patients, clinicians, manufacturers, regulators, and professional societies to share their perspectives on the safety and effectiveness of bioelectronic implants for vision restoration.

BACKGROUND

In 2017, more than 1 million people in the US met the definition of blindness (with 20/200 best-corrected visual acuity or less in the better-seeing eye)1,2 By 2050, this number is projected to increase to 4 million based on shifting demographics and an aging population.3 One approach to treating those with profound vision loss (e.g., patients suffering from late stage age-related macular degeneration, retinitis pigmentosa, trauma) is to use bioelectronic implants (e.g., retinal and cortical implants). These devices aim to achieve artificial perception, restore vision and aid in the achievement of tasks of daily living. However, there are unique considerations and technological challenges associated with the development and assessment of bioelectronic implants for vision restoration.

This public workshop aims to foster a conversation about these challenges and include discussions regarding the relevant regulatory pathways for these types of implants, nonclinical data requirements, possible novel safety and effectiveness clinical endpoints, aspects of technology translation, possible methods to conduct real-life daily activities assessments for low vision patients, and possible methods to collect patient reported outcome measures related to bioelectronic implants for vision restoration. The workshop will also include discussions related to patient perspectives and experiences with bioelectronic implants, and some of the elements that are important to patients when considering the benefits and risks of using these devices.

The FDA and University of Pittsburgh plan to release a summary of the proceedings following the workshop to share key takeaways from panel discussions, breakout sessions, and comments received.

DATE and TIME

This virtual workshop will be held on October 24-25, 2022 beginning at 8:30 a.m until 3:30 p.m ET

WEBCAST

AGENDA

Time (Eastern) Topic Name of Session Chair / Speakers
8:30 am - 8:45 am Day 1: Welcome and Introduction
  • Malvina Eydelman, MD
    Food and Drug Administration
8:45 am - 10:15 am SESSION 1: Bioelectronic Implants and Public Health Impact  
8:45 am - 9:05 am Why do we need Bioelectronic Implants?
  • José-Alain Sahel, MD
    University of Pittsburgh
9:05 am - 9:25 am Psychological Considerations
  • Thiran Jayasundera, MD
    University of Michigan
9:25 am - 9:45 am Socioeconomic Considerations
  • Nabin Paudel, PhD
    Retina International
9:45 am - 10:05 am Ethical Considerations
  • Joseph Fins, MD
    Weill Cornell Medicine
10:05 am - 10:15 am Patient Experiences  
10:15 am - 10:25 am Break  
10:25 am - 12:15 pm  SESSION 2: Technology and Regulation  
10:25 am - 10:45 am Subretinal Implants
  • Daniel Palanker, PhD
    Stanford University
10:45 am - 11:05 am Epiretinal Implants
  • Mark Humayun, MD, PhD
    University of Southern California Institute for Biomedical Therapeutics
11:05 am - 11:25 am Cortical Implants
  • Nader Pouratian, MD, PhD
    UT Southwestern Medical Center
11:25 am - 11:35 am Patient Experiences  
11:35 am - 12:15 pm Regulatory Background & Requirements
  • Michelle Gabriele Sandrian, PhD
    Food and Drug Administration
  • Lan Yue, PhD
    Food and Drug Administration
12:15 pm - 1:15 pm  Break  
1:15 pm - 2:40 pm SESSION 3: Patient Perspectives  
1:15 pm - 1:40 pm Patient Panel Introductions  
1:40 pm - 2:40 pm Moderated Patient Panel Discussion

Moderator:

  • Eva Rorer, MD
    Food and Drug Administration 
2:40 pm - 2:50 pm Day 1: Wrap-Up
  • Tieuvi Nguyen, PhD
    Food and Drug Administration

 

Time (Eastern) Topic Name of Session Chair / Speakers
8:30 am - 8:35 am Day 2: Welcome & Recap
  • Tieuvi Nguyen, PhD
    Food and Drug Administration
8:35 am - 9:45 am SESSION 4: Evaluation of Bioelectronic Implants: Safety  
8:35 am - 9:05 am Bioelectronic Implants: Overview of Clinical Safety Endpoints and Evidence
  • James Weiland, PhD
    University of Michigan
9:05 am - 9:45 am Moderated Q&A: Safety of Bioelectronic Implants

Moderator:

  • Michael Repka, MD, MBA
    Johns Hopkins University

Panelists:

  • Gislin Dagnelie, PhD, Johns Hopkins University
  • Mark Humayun, MD, PhD, University of Southern California Institute for Biomedical Therapeutics
  • Raymond Iezzi, MD, Mayo Clinic
  • Robert MacLaren, MB ChB DPhil FRCOphth FRCS FACS FMedSci, University of Oxford 
  • Joseph Martel, MD, University of Pittsburgh
  • José-Alain Sahel, MD, University of Pittsburgh
  • Philip Troyk, PhD, Illinois Institute of Technology 
  • James Weiland, PhD, University of Michigan
9:45 am - 9:55 am Break  
9:55 am - 11:35 am SESSION 5: Clinical Outcome Assessments and Patient Preference  
9:55 am - 10:20 am FDA Regulatory framework for Clinical Outcomes Assessments and Patient Preference
  • Fraser Bocell, PhD
    Food and Drug Administration
  • David Gebben, PhD
    Food and Drug Administration 
10:20 am - 10:40 am Clinical Outcomes Assessment for Bioelectronic Implants: NEI Perspective
  • Emily Chew, MD
    National Eye Institute
10:40 am - 11:10 am Clinical Outcomes Assessment and Performance-Based Testing for Bioelectronic Implants: University of Pittsburgh
  • Emily Grattan, PhD, OTR/L
    University of Pittsburgh
  • Rakie Cham, PhD
    University of Pittsburgh 
  • Jose Sahel, MD
    University of Pittsburgh 
11:10 am - 11:15 am Patient Experiences  
11:15 am - 11:35 am Moderated Q&A: Clinical Outcomes Assessment for Bioelectronic Implants

Moderator:

  • Michelle Tarver, MD, PhD
    Food and Drug Administration

Panelists:

  • Fraser Bocell, PhD
    Food and Drug Administration
  • Emily Chew, MD
    National Eye Institute
  • Todd Durham, PhD
    Foundation Fighting Blindness
  • Emily Grattan, PhD, OTR/L
    University of Pittsburgh
  • David Gebben, PhD
    Food and Drug Administration
  • John McInerney, MS
    Blind and Vision Rehabilitation Services of Pittsburgh
11:35 am - 12:20 pm Break  
12:20 pm - 1:30 pm SESSION 6: Effectiveness  
12:20 pm - 12:50 pm Bioelectronic Implants: Overview of Clinical Effectiveness Endpoints and Evidence
  • Gislin Dagnelie, PhD
    Johns Hopkins University
12:50 pm - 1:30 pm  Moderated Q&A: Effectiveness of Bioelectronic Implants

Moderator:

  • Elvin Ng
    Food and Drug Administration

Panelists:

  • Jessy Dorn, PhD
    Ceribell, Inc.
  • Shelley Fried, PhD
    Harvard Medical School
  • Yannick LeMer, MD
    Hôpital Fondation Adolphe de Rothschild
  • Sandra Montezuma, MD
    University of Minnesota
  • Mahi Muqit, MBChB BSc (Hons) FRCOphth PhD
    Moorfields Eye Hospital
  • Joseph F. Rizzo III, MD
    Harvard Medical School
  • Philip Troyk, PhD
    Illinois Institute of Technology
  • Daniel Yoshor, MD
    University of Pennsylvania
1:30 pm - 2:30 pm SESSION 7: Post-market Considerations  
1:30 pm - 1:50 pm FDA: Post-Approval Studies, Postmarket Surveillance and Real World Evidence
  • Nilsa Loyo-Berrios, PhD
    Food and Drug Administration
1:50 pm - 2:00 pm Patient Experiences  
2:00 pm - 2:30 pm  Moderated Q&A: Post-Market Considerations

Moderator:

  • Michael Repka, MD, MBA
    Johns Hopkins University

Panelists:

  • Patient Representatives
  • Megan Collins, MD
    Johns Hopkins University
  • Lloyd Diamond, CEO
    Pixium Vision
  • Nilsa Loyo-Berrios, PhD
    Food and Drug Administration
  • Flora Lum, MD
    American Academy of Ophthalmology
  • Elicia M Pillion, Au.D
    Walter Reed National Military Medical Center
  • Arup Roy, PhD
    Zikron, Inc.
  • Eberhart Zrenner, MD
    University of Tuebingen
2:30 pm - 3:40 pm  SESSION 8: Government Agency Opportunities for Device Innovation  
2:30 pm - 3:10 pm  Government Agency Programs for Bioelectronic Implants
  • Sohi Rastegar, PhD 
    National Science Foundation
  • Paek Lee, PhD 
    National Eye Institute
  • Lina Kubli, PhD
    Department of Veterans Affairs
  • Tian Wang, PhD
    Congressionally Directed Medical Research Programs
  • Joeanna Arthur, PhD
    Defense Advanced Research Projects Agency
  • Elvin Ng
    Food and Drug Administration
3:10 pm - 3:40 pm  Moderated Q&A: Government Agency Opportunities for Device Innovation

Co-moderators:

  • Mark Humayun, MD, PhD
    University of Southern California Institute for Biomedical Therapeutics
  • Jose Sahel, MD
    University of Pittsburgh

Panelists:

  • Malvina Eydelman, MD
    Food and Drug Administration
  • Tony Gover, PhD
    National Eye Institute
  • Lina Kubli, PhD, 
    Department of Veterans Affairs
  • Sohi Rastegar, PhD
    National Science Foundation
  • Tian Wang, PhD
    Congressionally Directed Medical Research Programs
  • Joeanna Arthur, PhD
    Defense Advanced Research Projects Agency
3:40 pm - 3:45 pm  Day 2: Workshop Concluding Remarks and Next Steps
  • Jose Sahel, MD
    University of Pittsburgh
  • Malvina Eydelman, MD
    Food and Drug Administration

STEERING COMMITTEE BIOSKETCHES

REGISTRATION

Online registration is now closed. The links to view the webcast are posted under the Webcast portion of this web announcement.

COMMENTS

Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket: FDA-2022-N-1542 by November 22, 2022.

Please refer to the Instructions for submitting comments (Regulations.gov) to the docket to ensure that your feedback is received.  

The Docket is no longer accepting comments on topics for discussion for this workshop.

The resulting discussions from the workshop and comments received in the docket will be taken into consideration.

CONTACT

For questions regarding workshop content, please contact:

Michelle Gabriele Sandrian
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
301-796-6620
CDRH-VisionWorkshop@fda.hhs.gov

REFERENCES

1 Centers for Disease Control and Prevention Prevalence Estimates, available at: https://www.cdc.gov/visionhealth/vehss/estimates/index.html

2 Flaxman AD, Wittenborn JS, Robalik T, Gulia R, Gerzoff RB, Lundeen EA, Saaddine J, and Rein DB, Prevalence of Visual Acuity Loss or Blindness in the US. JAMA Ophthalmol. 2021; 139(7):717-723.

3 Blindness Data and Statistics from the National Eye Institute, available at: https://www.nei.nih.gov/learn-about-eye-health/outreach-campaigns-and-resources/eye-health-data-and-statistics/blindness-data-and-statistics

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