Ironing out delivery wrinkles, Galderma posts phase 3 wins for liquid botulinum toxin A on route to FDA

Galderma has chalked up a pair of phase 3 wins for its liquid formulation botulinum toxin A, positioning it to submit the candidate for approval in the U.S. and other global markets. The formulation is designed to eliminate the need to reconstitute the aesthetic treatment from powder.

Botulinum toxin A, sold by AbbVie’s Allergan as Botox, is already used to temporarily reduce frown lines and crow’s feet. Allergan vacuum-dries its Clostridium botulinum type A neurotoxin complex and ships it in vials for reconstitution with saline. As Galderma sees it, the reconstitution step introduces the threat of variability, errors and risks that could affect the consistency of the outcomes. 

In response, the Swiss company developed a ready-to-use liquid botulinum toxin A with a proprietary strain and put it through two phase 3 clinical trials to assess its impact on frown lines and crow’s feet. Both studies hit their primary endpoints.

The frown lines clinical trial, READY-1, randomized 300 participants to receive Galderma’s formulation or placebo. After one month, 82.9% of recipients of the botulinum toxin had experienced at least a two-grade improvement on an assessment of frown line severity. No participants in the placebo cohort had such an improvement. 

Almost 40% of participants reported an effect on Day One, and the median time to onset of effect was two days. The median time to return to baseline severity was more than 24 weeks, the length of the trial.

The second study, READY-2, randomized 303 people with crow’s feet to receive Galderma’s formulation or placebo. In that trial, 51.8% of participants in the treatment cohort met the response criteria versus 1.4% of the subjects on placebo. Again, participants reported responses within a day or two of receiving the formulation and typically took 24 weeks to return to baseline severity.

Galderma plans to submit the data to U.S. and global regulatory authorities. European authorities gave a positive decision to Galderma’s liquid, ready-to-use botulinum toxin type A formulation last year.