SAFETY ISSUES
Corticosteroid moiety common to the 2 products
Dose-related CS AE’s observed in pivotal trials
Systemic availability and activity demonstrated
- PK studies show dose-related effect on HPA-axis
Potential for CS systemic effects should be assumed (on bone, eyes, connective tissue, and metabolism)
Pivotal and supportive studies not designed or powered to detect a difference in many aspects of CS systemic safety