Inside the FDA: Reflections from Dr. Wiley Chambers on Ophthalmic Drug Development

In this week’s episode of the BroadEYE Podcast, hosts Dr. Shawn Maloney and Dr. Carlos Quezada-Ruiz sit down with Dr. Wiley Chambers, recently retired Deputy Director of the Division of Ophthalmology at the U.S. Food and Drug Administration (FDA). With over 36 years at the FDA, Dr. Chambers offers a rare insider’s perspective on regulatory science, ophthalmic drug development, and the evolution of clinical trial oversight.

This episode explores:

• How ophthalmology regulation has changed over the decades
• Common pitfalls in pre-IND meetings and what smart innovators do differently
• Lessons learned from reviewing countless drug and biologic applications
• The future of FDA guidance in areas like rare disease, gene therapy, and digital endpoints

Dr. Chambers also shares personal reflections on mentorship, scientific integrity, and his transition out of federal service after a distinguished career.

About Our Guest Dr. Wiley Chambers served as a lead ophthalmic reviewer at the U.S. FDA from 1987 until his retirement in 2023. As Deputy Director of the Division of Ophthal