PRODUCTS

Aesthetics Clinical Program Update

PRODUCTS

Aesthetics Clinical Program Update

PIPELINE

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PRECLINICAL

PHASE 1

PHASE 2

PHASE 3

AESTHETICS

DaxibotulinumtoxinA

Glabellar (frown) lines

BLA under FDA review

Forehead lines

Lateral canthal lines

Upper facial lines

Positive results in all three open label Phase 2 studies to evaluate dosing and injection patterns

AESTHETICS

RHA® Collection RedensityTM

Perioral Rhytids (lip lines)

FDA approved in December, 2021

OTHER

Neuromodulators

Biosimilar to BOTOX®

Topical

Partnered with Viatris, Inc.

Neuromodulator Uses

A
B
C
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 – 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.
2 – 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.
3 – US Food and Drug Administration Guidance Document. Upper Facial Lines: Developing Botulinum Toxin Drug Products Available at: https://www.fda.gov/media/89195/download (2014), Accessed Aug 2019