Revance presents 4 AAD VMX ePoster abstracts examining phase 3 study data for DAXI, and the impact of HA filler manufacturing technologies on HA chain degradation.
Revance Therapeutics, an aesthetic biotechnology company, recently announced the presentation of 4 ePoster abstracts shown at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) from April 23-25, 2021.
Of the ePosters, 3 highlighted SAKURA phase 3 study data on the company’s investigational daxibotulinumtoxinA (DAXI) for injection of glabellar lines (GL).
The findings included the elimination of GL with DAXI through a novel graphical representation of the entire distribution of GL severity ratings and changing scores used to depict patterns of efficacy over time.1
The pooled data revealed that 80% of DAXI-treated subjects were rated as “none” at Week 4, and 35% at Week 12. Among subjects rated “severe” at baseline, 68% and 24% were also rated as “none” at both Weeks 4 and 12. This represents a 3-point improvement from baseline, with 90% of all subjects achieving a ≥2-point improvement from baseline to Week 4.1
The second poster examined data from a subgroup analysis of the efficacy, duration, and safety of DAXI injections among adult women across multiple SAKURA phase 3 age cohorts.2
The proportion of subjects who achieved none or mild GL per investigator at Week 4 were: 97.2% (18-45 year olds), 96.3% (>45-55), 96.9% (>55) and 96.7% (≥65), according to the poster.2
The third poster showcased results from an evaluation of how repeated DAXI use could affect the progression of static/resting GL.3
“DAXI-treated subjects showed substantial and progressive improvement in static GL with repeated treatment,” wrote the study authors.3 “The extended duration of therapeutic benefit observed with DAXI in dynamic GL provides a longer window of muscle hypoactivity, permitting an extended period for dermal remodeling to occur. This can potentially account for the progressive improvement in static GL observed over repeated DAXI treatments.”
Revance also presented a poster on the impact of hyaluronic acid (HA) filler manufacturing technologies on HA chain degradation.4
Soluble HA (sHA) fraction chain length was examined, along with the distribution in commercial filler products.
Using 13 US-marketed fillers from 5 manufacturing technologies, Size Exclusion Chromatography (SEC) examined the mean molecular weight of sHA released from the final formulation per syringe, and fragment sizes (<30 kDa, <100 kDa, and <250 kDa).
“Preserved Network Technology (PNT) fillers released the longest sHA fragment chains (~500-600 kDa). Vycross fillers released the shortest sHA fragment chains (~100-165 kDa). PNT released the lowest amount of sHA compared to other technologies for all 3 low [molecular weight] fragment size categories with 0% in the <30 kDa category. Conversely, Vycross released more of the shortest sHA fragment chains for all 3 low [molecular weight] categories,” wrote the study authors.4
Investigators concluded that most products using high molecular weight HA undergo significant HA chain degradation during the manufacturing process.
“These data continue to underscore the innovation that drives Revance’s aesthetics portfolio, including our investigational neuromodulator product, daxibotulinumtoxinA for injection, and the RHA® Collection, which was launched in September 2020,” says Roman Rubio, senior vice president of clinical development at Revance, in a press release announcing the posters.5