4. Conclusions
No neutralizing antibodies to daxibotulinumtoxinA were seen in this rigorous analysis from the large phase 3 program of DAXI, the novel BoNTA formulated with a PTD-containing excipient RTP004, in the treatment of glabellar lines. With repeat local injections of DAXI, the potential for developing binding antibodies to daxibotulinumtoxinA or RTP004 was low and did not lead to treatment failure or immune-related AEs. This first analysis of the risk of antibody formation to a PTD-containing drug product has demonstrated no impact of the peptide excipient, RTP004, on the immunogenicity profile of daxibotulinumtoxinA. These data suggest that the risk of treatment failure or local immune reactions following injection of DAXI is low. However, further evaluation in higher dose indications and with real-world clinical use will provide additional information.