The regulatory journey for ophthalmic drug-device products is increasingly complex, especially as innovation in delivery systems accelerates. With the FDA evolving its expectations around combination products, early-stage companies, clinical teams, and strategic partners face critical questions: Should approval start with the drug or the device? How should shifting regulatory precedents be handled? And what makes getting a device approved for the eye so uniquely difficult?

• Explore how organizations are sequencing drug and device development to meet FDA expectations without slowing down trials
• Learn how the FDA’s current stance on drug-device combinations is influencing design control, clinical strategy, and filing sequence for ophthalmic products
• Understand why ophthalmic delivery systems face higher scrutiny than systemic routes, and how preclinical modelling, sterilization, and biocompatibility are being adapted to meet ocular-specific risks
• See how early-stage teams are balancing innovation and regulatory risk by starting with basic delivery systems, then phasing in novel devices or platform technologies once clinical efficacy is validated