Conference Day One
Tuesday | December 10, 2025
8:30 am Digital Networking Room Opens
8:45 am Chair’s Opening Remarks
Unpacking The Latest Clinical Trial Readouts From Precision Approaches That To The Drivers Of Dry AMD And GA Therapeutics
9:00 am Clinical Insights From Ocugen’s OCU410 Gene Therapy for Dry AMD and Geographic Atrophy
Synopsis
- Characterizing Vector and promoter selection – ensuring compatibility with target retinal layers and pathologic processes
- Exploring strategies to minimize immunogenicity and dosing risk in elderly populations
- Unpacking the latest updates from the ArMaDa Phase ½ trial, discussing early safety signals, trial design for GA populations and long-term potential for slowing disease progression
9:30 am Assessment of an Bioengineered Implant for the Improvement of Visual Function in a Phase 2b Clinical Study in Patients with Geographic Atrophy
Synopsis
- Review of Design of Implant and Early Clinical Data
- Review of Design of Phase 2b Clinical Study
- Update on Phase 2b Clinical Trial
10:00 am Morning Break & Virtual Networking
Defining and Validating Clinically Meaningful Endpoints to Enable Regulatory Acceptance and Drive Clinical Adoption in Dry AMD and GA
11:00 am Loss of OCT Outer Retinal Bands as Potential Clinical Trial Endpoints in Intermediate Age-Related Macular Degeneration
Synopsis
- Insights into the longitudinal change in the outer retinal bands (EZ, ELM, RPE), in a cohort with iAMD and their correlation with functional change.
- Insight into the utility of these outer retinal bands as a potential clinical trial endpoint in iAMD interventional trials.
- Clinical benefit of earlier intervention with nanolaser therapy in the LEAD trial, when assessing the loss of the outer retinal bands.
11:30 am Rethinking Endpoints: How Lesion Location Drives Clinically Meaningful Measures of Impact in Dry AMD
Synopsis
- Understanding why lesion location, not just size or growth, is emerging as a more meaningful predictor of vision-threatening progression in dry AMD
- Discuss how spatial distribution of atrophy may influence endpoint sensitivity, patient stratification, and the interpretation of therapeutic benefit.
- Sharing insights from clinical data on spatial lesion impact to refine trial endpoints and improve outcome relevance
12:00 pm Comfort Break
12:15 pm Fireside Chat with Award-Winning Experts: Functionally Validated Structural Endpoints – Defining Biomarkers to Track Early Retinal Changes and Predict Transition to Intermediate AMD
Synopsis
An interactive panel discussion from academic leaders of the field to set the scene on endpoints for dry AMD and Geographic Atrophy. Ask your questions live to understand the expert’s opinions on key topics including:
- Identify key structural imaging features including hypertransmission zones, drusen, and photoreceptor layer thinning that signal early retinal degeneration
- Examine how structural changes correlate with functional decline, with a focus on rod-mediated dark adaptation (RMDA) as a potential early functional biomarker
- Explore how structure-function relationships can inform patient stratification, early-stage intervention strategies, and clinical endpoint development in emerging AMD
1:00 pm Developing Novel Endpoints: Defining Measurable Outcomes That Capture Clinical Meaning and Accelerate Dry AMD Drug Development
Synopsis
- Measuring the rate of change in the macular area of photoreceptor loss, assessed by spectral domain-optical coherence tomography (SD-OCT) and ellipsoid zone (EZ) mapping.
- Regulatory challenges when using a novel endpoint
- Insights from a late-stage trial design utilizing a novel structural-functional endpoint
1:30 pm Lunch Break
Overcoming the Delivery Barrier: Innovations in Targeted and Sustained Ocular Drug Delivery
2:30 pm Advancing Implant Technologies to Extend Durability, Reduce Patient Burden & Support Long-Term Treatment of Dry AMD
Synopsis
- Exploring how implantable drug delivery systems are engineered to provide sustained, controlled release of therapeutics directly to retinal tissues
- Evaluating delivery platform considerations for small molecule and biologic therapies, and how disease stage and progression patterns influence implant design and treatment duration
- Reviewing ongoing trial investigating implant-based delivery approach; insights into trial design, patient recruitment challenges, and early safety signals
3:00 pm Suprachoroidal Delivery for dry AMD: Targeted Suprachoroidal Access for Safer, More Precise Chorio-Retinal Drug Administration
Synopsis
- Comparing suprachoroidal delivery to conventional intravitreal injections: advantages in localizing therapy closer to disease sites with potentially improved safety profiles
- Exploring how suprachoroidal administration may limit anterior segment exposure and systemic circulation, reducing off-target effects
- Evaluating the potential to combine suprachoroidal delivery with gene therapy, small molecules, and sustained-release formulations to enhance efficacy
3:30 pm Comfort Break
Beyond the Complement Pathways: Exploring Novel Therapeutic Targets with Potential to Transform Dry AMD and Geographic Atrophy Treatment
4:00 pm Targeting Lipid Biology and Fatty Acid Metabolism to Restore Vision Loss in Dry AMD: ELOVL2 Gene Therapy for Dry AMD
Synopsis
- Restoring Retinal Homeostasis Through Lipid Biosynthesis: Understanding how the RPE’s role in fatty acid metabolism and waste clearance impacts photoreceptor integrity and survival
- Discussing ELOVL2 Gene Therapy as a Metabolic Rescue Strategy and how restoring fatty acid elongation supports retinal structure and function in aging and disease
- Evaluating ELOVL2 as a Therapeutic Platform: A potential first-in-class approach for modulating age-related metabolic decline in the retina and redefining treatment paradigms in dry AMD
4:30 pm A Novel Approach to Protect Photoreceptors and RPE Integrity to Slow Geographic Atrophy Progression
Synopsis
- Exploring the emerging role of ferroptosis — an iron-dependent, lipid peroxidation-driven form of programmed cell death in retinal pigment epithelium (RPE) dysfunction and photoreceptor degeneration in dry AMD
- Discussing how oxidative stress, iron accumulation, and impaired lipid metabolism converge to trigger ferroptotic pathways in the aging retina
- Presenting early Phase I trial results for PST-611, a novel gene therapy delivered via proprietary microneedle technology
