Galderma announces the presentation of data from clinical trials of its aesthetic solutions and pipeline in five abstracts at the virtual American Society for Dermatologic Surgery (ASDS) 2020 Annual Meeting.
The company also announced that it has completed patient enrollment in several clinical trials supporting a Phase 3 program of relabotulinumtoxinA (QM1114), its proprietary novel, ready-to-use, liquid formulation of investigational botulinum toxin, for the treatment of glabellar lines and lateral canthal lines. The Phase 3 program, called READY (RElabotulinumtoxin Aesthetic Development studY), enrolled over 1,900 patients across 60 sites in the United States and Canada in four clinical trials – three multi-center, randomized, double-blind, placebo-controlled studies and one long-term open-label study.
RelabotulinumtoxinA clinical trials will evaluate rapid onset, long duration, and additional patient measures as part of the large clinical program for this next generation botulinum toxin. The liquid formulation will be ready to use upon arrival and will not require in-office reconstitution before administration, it will reduce preparation time, and has the potential to increase accuracy and improve patient outcomes, in contrast with current treatments that require reconstitution by clinicians before administration.
Derived from Galderma’s proprietary strain of Clostridium botulinum bacteria and created using an animal-origin free process, relabotulinumtoxinA will be manufactured in Galderma’s new state-of-the-art Center of Excellence in Aesthetics in Uppsala, Sweden.
Galderma’s Data Presentations at ASDS 2020
During the ASDS meeting, Galderma will present clinical research findings across its neurotoxin and dermal fillers portfolio. The company’s oral and poster presentations will highlight results from the DREAM (Dysport Real-world Evaluation and Measured satisfaction) study of Dysport (abobotulinumtoxinA) for Injection, which demonstrated high levels of patient satisfaction and natural-looking results with only two treatments per year.
Additionally, Phase 3 clinical research showed that Restylane Defyne was effective for correction of chin retrusion and was associated with a high degree of patient satisfaction, and Restylane Kysse was shown to be effective for lip augmentation over a 48-week treatment period with a high degree of patient satisfaction. In a Phase 4 study of Restylane Kysse, both subjects and their partners were satisfied with the subjects’ lips after treatment.
Details About Galderma’s Presentations
- A randomized, no-treatment controlled, evaluator-blinded, multi-center phase 3 study to evaluate the effectiveness and safety of HARD in the chin for augmentation and correction of chin retrusion – Dr. Anne Chapas (Oral Abstract: Friday October 9, 9:09-9:12 a.m.)
- A randomized, controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of HAkys versus a control in augmentation of soft tissue fullness of the lip – Dr. Sue Ellen Cox (Oral Abstract: Friday October 9, 9:03-9:06 a.m.)
- Post marketing study to evaluate lip enhancement, naturalness, and satisfaction of both subject and partner after treatment with HARK – Dr. Vince Bertucci (Oral Abstracts #5: Saturday, October 10, 11:30-11:33 a.m.)
- Subjects are highly satisfied with two treatments of abobotulinumtoxinA a year: results from multi-center, year-long, longitudinal study – Dr. Ava Shamban (e-poster)
- A randomized, evaluator-blinded, multi-center phase 3 study to evaluate safety and effectiveness of a biostimulatory poly-l-lactic acid injectable implant after changes in reconstitution – Dr. Melanie Palm (e-poster)
[Source(s): Galderma, PR Newswire]