Nick Quartapella

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.

Asked for clarification on the FDA's view on rescue injections, including whether there are limits on the number or timing of rescues that could impact the primary endpoint analysis.

Answer

The FDA has not set a specific limit on the number or timing of rescue injections. The trial is an intent-to-treat study, and rescues in both the treatment and control arms will be handled through sensitivity analyses, consistent with prior FDA interactions.

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.