Nick Quartapella's questions to EyePoint Pharmaceuticals (EYPT) leadership • Q1 2025
Question
Nick Quartapella, on behalf of Colleen, asked for clarification on how the FDA views the impact of rescue medications on the primary endpoint, including any limits on the number or timing of rescues.
Answer
President and CEO Dr. Jay Duker explained that the FDA has not specified a limit on rescues that would disqualify a patient. The trials use an intent-to-treat analysis for the primary endpoint, with sensitivity analyses for supplemented patients in both the treatment and control arms. He noted the FDA has not imposed any specific timing restrictions for rescues.