Show Summary

This episode of RetinUp opens with a timely policy discussion between the hosts about proposed Medicare and Medicaid funding cuts, exploring what they could mean for retina practices and their most vulnerable patients.

The Vitreoretinal View segment features John Kitchens, MD, sharing his decade-long experience with heads-up 3D visualization. He reviews what makes it transformative for training and surgical outcomes, why widespread adoption has been slower than expected, and what might finally tip the scales.

In the main interview, Stanford's Darius Moshfeghi, MD, joins Scott and John to break down the SOL-1 Phase 3 superiority study on Axpaxli (OTX-TKI), Ocular Therapeutix's investigational bioresorbable intravitreal hydrogel incorporating axitinib. He discusses his unique role as an independent rescue monitor, explains the study's novel design, unpacks what the superiority outcome over aflibercept actually means for clinical practice, and previews what the SOL-R study may tell us next.

Hosts: John Kitchens, MD, Scott Krzywonos

Guests: Darius Moshfeghi, MD – Chief, Retina Division; Professor, Byers Eye Institute, Stanford University School of Medicine

Topics Covered

SOL-1 Study: Design, Findings & Context (Darius Moshfeghi, MD)

• The independent rescue monitor role: what it is, how it worked, and why it was created for SOL-1
• SOL-1’s study design, superiority outcome, and floaters data (and why they were not clinically concerning)
• Superiority vs. non-inferiority: implications for labeling, step therapy avoidance, and physician adoption
• How retina specialists could integrate Axpaxli into their practice protocols
• How SOL-R differs from SOL-1, and what SOL-R might show us

Vitreoretinal View: Heads-Up 3D Visualization

• Origins of heads-up 3D: TruVision and Alcon NGenuity
• Zeiss and Heidelberg heads-up visualization systems
• Why John adopted NGenuity early and continues to use it
• Key benefits: surgical video quality, fellow training, and real-time coaching
• Cost considerations and other reasons why adoption has remained low
• The anterior segment opportunity: how cataract surgery economics may drive broader uptake

Medicare & Managed Care Policy Concerns

• Proposed $200 billion in federal budget cuts and the potential impact on Medicare and Medicaid
• Risk of increased step therapy, Avastin-first policies, and tiered drug coverage
• Access-to-care concerns for Medicaid patients, particularly at academic medical centers
• The difference between traditional Medicare and managed Medicare (Medicare Advantage)
• Historical context: past Congressional threats to Medicare reimbursement and how they've played out

Key Takeaways

• The independent rescue monitor role pioneered in SOL-1 reflects a novel, collaborative approach to adjudicating vision-threatening events in clinical trials.
• Physicians will likely adapt AXPAXLI into existing treat-and-extend protocols; SOL-R's more traditional design may generate data that resonates more directly with clinical practice.
• SOL-1 is the first superiority study in retina/ophthalmology, demonstrating that a single injection of Axpaxli (Ocular Therapeutix) outperforms aflibercept 2mg (Regeneron) on vision maintenance — with durability extending well beyond current approved dosing intervals.
• Heads-up 3D visualization offers meaningful advantages for surgical training and video quality, but high costs for integrated systems and declining surgery center reimbursements continue to limit adoption.
• Proposed federal budget cuts to Medicare and Medicaid represent a real threat to retina practices and patient access, particularly for drug coverage and underserved populations.

Credits Production & Marketing: Laura Brown | Business Operations: Liz Hogan