Neuromodulator: DaxibotulinumtoxinA for Injection

Our investigational neuromodulator product, DaxibotulinumtoxinA for Injection, is aiming to establish a new, premium, long-lasting neuromodulator category.

DaxibotulinumtoxinA for Injection is an investigational agent that has not been approved by the FDA and is currently under regulatory review.

Neuromodulator: DaxibotulinumtoxinA for Injection

Our investigational neuromodulator product, DaxibotulinumtoxinA for Injection, is aiming to establish a new, premium, long-lasting neuromodulator category.

DaxibotulinumtoxinA for Injection is an investigational agent that has not been approved by the FDA and is currently under regulatory review.

Pipeline

The consumer experience has remained largely unchanged since botulinum toxin type A treatments were first introduced over 30 years ago.

1st place ribbon

First and only neuromodulator product candidate with a proprietary peptide formulation.

Once approved, we expect that people treated with DaxibotulinumtoxinA for Injection may achieve frown line correction with as few as two treatments per year.1
Botulinum Toxin Type A

150kD Botulinum Toxin Type A

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Stabilizing Peptide Excipient

150kD Botulinum Toxin Type A

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Buffers Sugar and Polysorbate 20

150kD Botulinum Toxin Type A

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DaxibotulinumtoxinA for Injection

150kD Botulinum Toxin Type A

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DaxibotulinumtoxinA is developed and manufactured exclusively in the U.S.

Revance employs in-house, state-of-the-art manufacturing and analytics capabilities, and holds 418 issued patents in the US, EU, Latin America and Asia, as of December 31, 2019.

DaxibotulinumtoxinA for Injection has been evaluated in the largest aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar (frown) lines

Based on results from the SAKURA program (SAKURA 1, 2, 3), we expect that people treated with DaxibotulinumtoxinA for Injection may achieve frown line correction with as few as two treatments per year.1

SAKURA RESULTS

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Subjects achieved a two-grade improvement in glabellar lines as assessed by with the patient and the investigator at week 4 after treatment.1
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Response rate for DaxibotulinumtoxinA for Injection across the largest phase 3 program of an aesthetic neuromodulator in glabellar lines.1
*This data point represents percent of subjects achieving glabellar line severity of none/mild at week 4.
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wks
The median time to loss of none or mild wrinkle severity in clinical trials with DaxibotulinumtoxinA for Injection.2
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wks
The median time to return to baseline wrinkle severity in the SAKURA program2

Aesthetics Clinical Program Update

PRECLINICAL

PHASE 1

PHASE 2

PHASE 3

AESTHETICS

DaxibotulinumtoxinA for Injection

Glabellar (frown) lines

BLA under FDA review

Forehead lines

Lateral canthal lines

Upper facial lines

Positive readout in June 2020
Positive readout in June 2020
Positive readout in December 2020

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daxibotulinumtoxinA For Injections injection Aesthetics Pipeline

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Neuromodulator placement on a face

DaxibotulinumtoxinA for Injection is currently under regulatory review for the treatment of moderate to severe glabellar (frown) lines. The review includes results from three Phase 3 trials (SAKURA 1,2,3), the largest aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar (frown) lines. DaxibotulinumtoxinA for Injection has also been evaluated in a Phase 2 head-to-head, active comparator study (BELMONT). DaxibotulinumtoxinA for Injection is an investigational agent that has not been approved by the FDA and is currently under regulatory review.

DaxibotulinumtoxinA for Injection was evaluated in a Phase 2 open-label study for the treatment of moderate to severe dynamic forehead lines (frontalis) following glabellar line injection. An interim analysis from the study found that treatment with DaxibotulinumtoxinA for Injection substantially improved the appearance of forehead lines versus placebo at all doses tested 4 weeks after treatment and resulted in high patient satisfaction.1

Lateral canthal lines, commonly known as crow’s feet, are associated with a combination of muscle movement, loss of volume around the eyes, skeletal changes and a reduction in skin quality.3 DaxibotulinumtoxinA for Injection was evaluated in a Phase 2 open-label study for the treatment of moderate to severe lateral canthal lines, commonly known as crow’s feet. Clinical data demonstrated positive efficacy results and that DaxibotulinumtoxinA for Injection was well tolerated.

Revance evaluated DaxibotulinumtoxinA for Injection in an open-label Phase 2 study for treatment of the full upper face, including glabellar (frown) lines, forehead lines and crow’s feet (lateral canthal lines). The study was conducted to understand the safety and efficacy, including potential dosing and injection patterns, of DaxibotulinumtoxinA for Injection. In December 2020, Revance announced positive topline efficacy and safety results from its Phase 2 study. For the latest information regarding our clinical development programs, please see our public filings with the Securities and Exchange Commission or visit clinicaltrials.gov.

References
1 – Carruthers JD, et al. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2). Plast Reconstr Surg. 2020;145(1):45–58. doi:10.1097/PRS.0000000000006327
2 – Fabi SG, et al. Results of a Large Open Label Safety Study of Daxibotulinumtoxina for Injection in Glabellar Lines. Podium presentation at 2019 ASDS. 26 October, 2019. Chicago, Illinois.
3 – Nowell Solish, et al. A Phase 2a Dose-Escalation Study to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Dynamic Forehead Lines Following Glabellar Line Injections: An Interim Analysis. Poster presentation at 2020 Annual Maui Derm for Dermatologists meeting. 25-29 January 2020. Maui, Hawaii.
4 – Tung, R, et al., Treatment of lateral canthal rhytides with a medium depth chemical peel with or without pretreatment with onabotulinum toxin type A: a randomized control trial. International Journal of Women’s Dermatology, Volume 2, Issue 1, 1 March 2016, Pages 31-34.