Expediting Innovation of Bioelectronic Implants for Vision Restoration

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. We are soliciting ideas for specific topics within these areas for discussion at the public workshop (see Registration). Ideas for the workshop will be accepted until August 19th (see Submit Comments). 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.