Thursday, May 29, 2025
7:30 am Check In & Morning Coffee
8:25 am Chair’s Opening Remarks
NAVIGATING THE REGULATORY LANDSCAPE TO OBTAIN APPROVALS FOR NOVEL IMAGING BASED BIOMARKERS
8:30 am Regulatory Strategy for Evolving Retinal Imaging Endpoint to Streamline Approval
Synopsis
- Exploring the introduction novel retinal imaging biomarkers into regulatory submissions
- Reviewing functional vs. structural endpoint considerations
- Analyzing opportunities to support novel retinal imaging endpoints
9:00 am Utilizing VR Guided Multi Luminance Orientation and Mobility Testing for Assessment of Visual Function
Synopsis
- Exploring how virtual reality stimulators can help connect structural changes in the retina with functional outcomes
- Leveraging these tests to help define clinically meaningful improvements
- Discussing how secondary or exploratory functional endpoints can be validated and transitioned into primary endpoints for clinical trials
9:30 am Panel Discussion: Delving into FDA vs EU Perspective on Retinal Imaging Endpoints to Demonstrate Functional Vision
Synopsis
- Detailing how the FDA and EU approach the adoption of new retinal imaging technologies
- Discussing the divergent regulatory standards of each organization
- Highlighting the growing focus on functionality and quality of life improvements for patients
10:00 am Morning Coffee Break & Networking
ENSURING DATA HARMONIZATION ACROSS MULTIPLE IMAGING MODALITIES TO ENSURE VALIDITY OF READOUTS
11:00 am Standardizing Data Across Retinal Imaging Modalities for Better Trial Outcomes
Synopsis
- Emphasizing the importance of creating standardized protocols to ensure consistency and accuracy in multi-center trials
- Creating protocols to ensure harmonization of data
- Examining the technical barriers involved in aligning measures such as image quality, resolution, and acquisition methods
RETINAL IMAGING AS A WINDOW INTO NEUROLOGICAL DISEASE EXPLORING VASCULAR AND STRUCTURAL BIOMARKERS FOR EARLY DETECTION AND MONITORING
11:30 am Utilizing Retinal Imaging for Early Detection & Monitoring of Neurological Disorders
Synopsis
- Examining the correlation between OCT and MRI findings to predict neurodegeneration in MS
- Leveraging visual assessments in preclinical testing to evaluate neuroprotective strategies
- Investigating the role of visual imaging in the early detection of neurological diseases
12:00 pm Exploring Neurologic Disease Pathways Via Retinal Vascular Biomarkers to Accelerate Detection
Synopsis
- Quantifying retinal putative glial alterations as a potential indicator of vascular dysregulation in neurologic disease
- Insights from OCTA for characterizing retinal vascular dysregulation using diabetic retinopathy as a model
- Understanding the contribution of vascular dysregulation in neurologic disease using OCTA biomarkers as window
12:30 pm Panel Discussion: Exploring Emerging Imaging Technologies for Diagnosis & Prognosis
Synopsis
- Utilizing adaptive optics to enhance cellular-level imaging for early disease detection
- Exploring DARC Technology for real-time assessment of retinal health and neurodegeneration
- Considering ultra-wide field retinal imaging for improved disease tracking
- Microperimetry potential for mapping functional vision loss with precise correlation to structural changes
1:00 pm Lunch & Networking
DELVING INTO COMMERCIAL TRENDS, TRIAL INSIGHTS, AND THERAPEUTIC APPLICATIONS TO SPEARHEAD DEVELOPMENT
2:00 pm Fireside Chat: Commercial Trends & Opportunities in Retinal Imaging Biomarkers & Endpoints
Synopsis
- Examine the evolving landscape of retinal imaging biomarkers in AMD, focusing on advancements in detecting disease progression and treatment efficacy
- Analyze unmet needs and opportunities for innovation, emphasizing the potential of novel imaging technologies and AI-driven analyses to enhance precision, durability, and patient care
- Explore collaboration across research and industry to standardize biomarkers and accelerate their clinical utility
2:30 pm Delving Into Emerging Insights for Trial Endpoints Analyzing Correlations Between FST & MLMT
Synopsis
- MLMT is a well-established, clinically meaningful endpoint
- FST is a reproducible measure of retinal function but has not yet been embraced by the FDA as a clinically meaningful endpoint
- Correlation between FST and MLMT will be presented, supporting the clinical meaningfulness of changes in FST
3:00 pm Harnessing Retinal Imaging Modalities to Evaluate the Efficacy of Optogenetic Therapy
Synopsis
- Utilizing OCT detect optogenetically treated retinal areas
- Monitoring functional changes in optogenetically sensitized retinal cells in response to light stimulation
- Employing OCT to assess structural alterations