Synopsis

While the first therapies for GA have recently received FDA approval, many promising candidates continue to stall in early or mid-stage trials due to challenges in trial execution, patient recruitment, and regulatory alignment. Given the unique demands of dry AMD and GA, particularly the slow disease progression and patient heterogeneity, developing a robust dry AMD and GA clinical strategy is not only essential for successful regulatory approval, but also critical for securing investment and sustaining momentum through development.

Join this workshop to:

• Examine how to adapt trial protocols to reflect differences in disease progression across global patient populations, including geographic and ethnic variation
• Uncover practical approaches to streamline patient recruitment and improve site-level trial execution through partnerships with specialist trial sites and reading centres
• Take a deep dive into study design considerations, data requirements and the expectations at each stage of development: from preclinical to approval
• Discuss the role of preclinical data in IND submissions and how to align translational findings with clinical development plans
• Uncover practical approaches to streamline patient recruitment and improve site-level trial execution through partnerships with specialist trial sites and reading centres
• Hear from leaders of late-stage trials on navigating FDA and EMA regulatory processes and aligning development plans with evolving agency expectations

Synopsis

As clinical development in dry AMD and geographic atrophy accelerates, the field remains divided on how best to define success. Should structural imaging biomarkers take precedence for their

quantifiability, or do functional endpoints better capture what truly matters to patients? While OCT-based metrics like hypertransmission and EZ loss may offer precision, they are unable to reflect visual experience. Meanwhile, functional tests like dark adaptation provide insight into real-world impact-but are often variable, time-consuming, and harder to validate.

This workshop will: 

• Host a dynamic debate between leading experts representing structural and functional endpoint perspectives
• Examine the strengths and limitations of current structural markers, including OCT volume-based metrics, autofluorescence, and hypertransmission
• Explore the role of functional endpoints such as dark adaptation, microperimetry, and contrast sensitivity in measuring meaningful patient outcomes
• Discuss regulatory precedent: how have agencies responded to structure vs function in trial submissions, and what’s gaining traction?