Global pharmaceutical company Galderma’s liquid formulation of botulinum toxin type A has achieved positive results for the treatment of glabellar lines in a phase 2 clinical trial.
The results of the phase 2 multicenter, randomised, double-blind, placebo-controlled clinical trial using QM1114 ready-to-use investigational botulinum toxin demonstrated initial safety and efficacy at all doses in the treatment of glabellar lines in more than 350 patients, with high patient satisfaction.
QM1114 is derived from Galderma’s proprietary strain of Clostridium botulinum bacteria and manufactured using an animal-origin free process. It is designed and developed specifically for use in aesthetics as a liquid formulation, aiming to reduce preparation time needed in clinic as it is ready-to-use rather than requiring reconstitution before administration.
Following the trial results, Galderma has received a manufacturing license from the Swedish Medical Products Agency (MPA) for a new state-of-the-art manufacturing facility at the Center of Excellence, located in Uppsala, Sweden. Phase 3 trials for Galderma’s liquid formulation of botulinum toxin type A for the treatment of glabellar lines are expected to begin soon and will involve approximately 1,500 subjects.
"As a physician, I need to be confident that innovation in aesthetic treatment is the result of scientific rigor. I am encouraged by the results of the Phase 2 QM1114 study, which demonstrated initial safety and efficacy at all doses with high patient satisfaction," said board certified dermatologist Dr Joel Cohen, investigator in the phase 2 clinical trial. Dr Cohen added, "It is exciting to see the development of a new toxin formulation that can offer convenience and the potential to eliminate the need for reconstitution in my practice."