RetinUp – Episode 3: Shutdown’s Effects on FDA ft. Alec Gaffney from POLITICO | Plus, PRIMA Implant + GLP-1 Data Dump

Hosts:

John Kitchens, MD

Scott Krzywonos

Guest:

Alexander Gaffney, VP of Regulatory Policy & Intelligence, Agency IQ / POLITICO

Show Summary:

In this episode, Scott calls in from the Outer Banks to discuss two major clinical headlines before turning to federal policy. First up is the PRIMA retinal prosthesis, a wireless subretinal chip that helped patients with geographic atrophy regain partial reading vision. Then, Scott and John analyze the rapidly expanding — and often contradictory — body of research on GLP-1 receptor agonists and their links to retinal disease.

In the second half, they welcome Alexander Gaffney from POLITICO’s Agency IQ for a deep dive into how the ongoing government shutdown and widespread staff reductions are affecting the FDA’s ability to review and approve ophthalmic therapies. From PDUFA carry-over funds to workforce attrition, Alec explains why the true impact may not be the shutdown itself, but the backlog that follows.

Topics Covered:

• PRIMA retinal implant: wireless innovation and its surgical challenges
• The trade-off between functional vision gains and expanded atrophy area
• GLP-1 receptor agonists: mixed data on AMD, DR, and DME risk
• FDA shutdown implications for ophthalmic trials and approvals
• The reduction in force across FDA divisions and its effect on review capacity
• How new leadership and the National Priority Voucher Program aim to modernize the agency
• Why backlogs could extend into 2026 for gene therapy and TKI programs

• “I’m less worried about the shutdown itself — I’m worried about what happens afterward.” — Alexander Gaffney
• “You might not be able to read or drive, but that peripheral vision is what lets you move through the world. Losing more of that matters.” — John Kitchens, MD
• “We don’t always know what we’ve lost — how much faster certain drugs might have reached patients.” — Scott Krzywonos

Production & Marketing: Laura Brown

Business Operations: Liz Hogan

Listen and Subscribe:

RetinUp.com | Available on Apple Podcasts, Spotify, and YouTube