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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.
