A biotech company preparing a New Drug Application (NDA) for a Geographic Atrophy (GA) treatment faced a critical hurdle:
- Multiple clinical trials with different designs and patient populations
- Requirement for robust integrated safety and efficacy evidence
- Tight timelines with no room for error or delays
IDDI led the development of the Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE):
- Aligned data across multiple ophthalmology trials
- Focused analysis on the most clinically relevant dose (2mg)
- Designed a robust pooling strategy aligned with regulatory expectations
- Worked in parallel with client teams to maintain timelines
The result: clear, regulator-ready cross-study evidence
- Demonstration of safety and efficacy at the program level
- FDA approval achieved
- EMA accepted the Market Authorization Application two weeks later
When data complexity threatens progress, the right statistical strategy makes approval possible.