European Medicines Regulatory Network (EMRN) workshop on Geographic Atrophy endpoints
EventHuman
Date
- Wednesday, 29 April 2026, All day
Location
- OnlineEuropean Medicines Agency, Amsterdam, the NetherlandsLive broadcast
Event summary
Geographic atrophy (GA) is a slowly progressing and seriously debilitating condition with a high prevalence and unmet medical need. GA has a major impact on patients/families from a health and quality of life perspective. To support a Centralised marketing authorisation for a medicinal product in GA, it is necessary to show a clinically relevant treatment benefit of the medicinal product on visual function. Alternative primary endpoints to demonstrate efficacy of the medicinal product, e.g based retinal imaging, must be able to robustly predict the clinically relevant treatment benefit of the medicinal product on visual function.
Therefore, there is a need to discuss the state of the art on functional endpoints for GA and retinal imaging with stakeholders in order to facilitate medicinal product development for GA, and thus address the unmet need for many EU patients with GA. Relevant stakeholders include patients and carers, healthcare professionals, academics and industry concerned with the development of medicinal products for GA.
The aims of the workshop are:
- to communicate the principles/regulatory expectations for endpoints to support the risk benefit assessment of medicinal products, to identify gaps in research and to encourage further necessary work on endpoints to meet regulatory expectations;
- to allow public presentation of: the state of the art on candidate functional endpoints in GA, and an overview of how structural changes and retinal function inter-relate;
- to encourage wider discussion from stakeholders into identified discussion points.
Registration
Registration to the workshop opens on 16 February 2026.
Registration for online participation remains open until 14 April 2026.
The event is live broadcast. Video recording is published after the event.