No specific genotoxicity studies (e.g., Ames test, chromosomal aberration assay) were conducted. Justification: Voretigene neparvovec is based on a replication-incompetent AAV vector, which is known to persist primarily as a non-integrating, episomal form in the nucleus of transduced cells. The risk of random insertional mutagenesis is considered very low. This approach is consistent with FDA guidance for gene therapy products based on non-integrating vectors.