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

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
Webcast
Agenda
Steering Committee Biosketches
Registration
Comments
Contact
References

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

October 24: Bioelectronic Implants Workshop Day-1
October 25: Bioelectronic Implants Workshop Day-2

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

Expediting Innovation of Bioelectronic Implants for Vision Restoration Public Workshop 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

Event Materials

Title	File Type/Size
Expediting Innovation of Bioelectronic Implants for Vision Restoration Biosketches	pdf (992.03 KB)
Transcript - October 24, 2022	pdf (932.19 KB)
Transcript - October 25, 2022	pdf (1.37 MB)