Nick Quartapella's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership • Q1 2025
Question
Nick Quartapella, on behalf of Colleen at Robert W. Baird & Co., asked for more color on how the FDA views the impact of rescue injections on the primary endpoint for wet AMD, including any limits on the number or timing of rescues.
Answer
President and CEO Dr. Jay Duker explained that based on their FDA interactions, there is no set number of rescues that would eliminate a patient from the intent-to-treat analysis. He clarified that the top-line data will include all patients, with sensitivity analyses applied to those who received supplements. The FDA has not specified any restrictions on the timing of rescues or suggested that a rescue at a certain point would lead to exclusion from the study.