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Date: September 17, 2025 Time: 9:30 a.m. – 2:30 p.m. ET
The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the U.S. Food and Drug Administration, is convening a one-day hybrid public meeting on September 17, 2025 focused on novel efficacy endpoints used in interventional clinical trials for drugs and biologics intended for patients with severe vision loss to support regulatory decision making. The meeting will focus on full-field stimulus threshold testing and ellipsoid zone data. Researchers, clinicians, and other parties will present and discuss evidence and data that may support the use of these tools in regulatory decision-making, such as clinical and statistical considerations for quantifying a clinically meaningful change. Discussion will also include current limitations and potential strategies to advance the use and implementation of these tools to support regulatory decision-making.
For more information about the program and meeting registration, please visit the Margolis Institute for Health Policy.
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Content current as of:
09/02/2025
