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Introduction
The Foundation Fighting Blindness conducted a virtual externally-led patient focused drug development (EL-PFDD) meeting on dry AMD on March 1, 2024.
The purpose of this meeting was to share with key FDA officials and other stakeholders the journey of dry AMD patients and their caregivers across the lifespan, current unmet needs, prognosis, and current standards of care. We invited people living with dry AMD and caregivers, to participate in a live discussion with drug developers, researchers, and regulators, as well as healthcare policy makers and payors for purposes of informing clinical trial design and benefit-risk decision making for evaluating and approving treatments for this disease.
Since there are limited approved therapies for dry AMD, it is important for stakeholders to understand how patients and their caregivers are impacted by the condition, their limited treatment options, and take into consideration their unique perspectives for future development and therapeutic review. The Foundation Fighting Blindness is committed to ensuring that the data, infrastructure, and tools needed to support and drive drug development for patients with dry AMD are available.
This EL-PFDD meeting was a key component of realizing this objective, by capturing patient and caregiver insights that could set the context for FDA benefit-risk considerations. It enabled a comprehensive understanding of this disabling condition for key reviewers in all offices of the FDA.
Voice of the Patient Report
The Foundation Fighting Blindness first and foremost wishes to thank all those living with dry age-related macular degeneration (dry AMD) and their loved ones and caregivers who attended the March 1, 2024 meeting. Thank you for sharing your experiences and insights about living with dry AMD. Thank you also to those who contributed by phoning in or contributing their insights online. We dedicate this report to all of you.
