Conference Day Two
Wednesday | December 11, 2025
8:45 am Chair’s Opening Remarks
Navigating the Retinal Regulatory Landscape: Global Development Strategies for Dry AMD & Geographic Atrophy Approvals
9:00 am Building a Regulatory-Ready Preclinical Package in Dry AMD: Understanding the Evidence, Tools, and Models Required to De-Risk Early Development
Synopsis
- Analyze lessons from recent approvals and rejections
- Outline preclinical evidence requirements that regulators expect to see
- Review the role of translational assays, imaging, and endpoints to de-risk translation
- How to align animal models with clinical endpoints to support IND submission
9:30 am Working With Regulators: Designing Trials That Lead to Approval
Synopsis
- Share strategies for successful regulatory engagement throughout the full development timeline from pre-IND to BLA/NDA submission
- Tools for managing international trial variability
- Reflections on regulatory engagement strategy across trial phases
- Debate future directions in regulatory science to better accommodate novel endpoints, combination therapies, and precision medicine approaches in dry AMD
10:15 am Morning Break & Virtual Networking
Preserving Vision in Dry AMD: Mechanisms and Innovations in Early Intervention
10:45 am Unveiling How C1q Pathway Activation Drives the Loss of Synapse and Retinal Function in a Photoreceptor Damage Model Reflective of AMD Pathology
Synopsis
- Investigate how C1q drives synapse loss and retinal dysfunction in preclinical models of photoreceptor damage and its emerging link to AMD pathology
- Discuss how mechanism-informed model selection, particularly for complement and neuroinflammatory pathways, can improve clinical translation and therapeutic targeting
- Explore opportunities for earlier intervention through neuroprotective and synapse-preserving strategies in dry AMD
11:15 am Photobiomodulation Device Therapy: Harnessing Light-Based Mitochondrial Rescue to Delay Dry AMD Progression
Synopsis
- Translating the science behind photobiomodulation (PBM) — targeting mitochondrial dysfunction, oxidative stress, and cellular energy deficits in RPE and photoreceptors
- Examining ongoing studies investigating PBM’s role in intermediate AMD, GA progression, and long-term visual outcomes
11:45 am Lunch Break
Advancing Retinal Precision Medicine: Harnessing AI, Imaging & Predictive Analytics to Transform Dry AMD & GA Research
1:00 pm Data-Driven Discovery: The Role of AI & Emerging Tools in AMD disease prognosis
Synopsis
- Discussing how AI and machine learning models are applied differently in preclinical screening versus clinical endpoint prediction for dry AMD & geographic atrophy
- Comparing the utility and limitations of AI tools across stages of development, including variability in data sources, translational relevance, and regulatory acceptance
- Highlighting opportunities for AI to streamline the transition between discovery and development — enabling better target selection, patient stratification, and trial enrichment
1:30 pm Brainstorm Sessions for Expert Panel
1:45 pm Investor Panel: Funding Retinal Innovation — Strategies to Advance Dry AMD & GA Therapies from Discovery to Clinic
Synopsis
- Explore how investors evaluate early-stage retinal programs with novel mechanisms targeting dry AMD and GA
- Discuss key data inflection points (preclinical validation, safety studies, early efficacy signals, regulatory alignment) that attract venture and institutional funding
- Review challenges specific to funding AMD programs including long development timelines, endpoint complexity, and patient heterogeneity