Disclosures

Did you receive any funding to support your research for this TOPIC?
Yes
Please specify entities (individual, company, society): I am an employee of Allergan Aesthetics, an AbbVie company

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work is presented thanks to the support of: Allergan Aesthetics, an AbbVie company

Disclosures

Did you receive any funding to support your research for this TOPIC?
No

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work was not supported by any direct or non direct funding. It is under the author's own responsability

Disclosures

Did you receive any funding to support your research for this TOPIC?
Yes
Please specify entities (individual, company, society): Merz

Were you provided with any honoraria, payment or other compensation for your work on this study?
Yes
Please specify entities (individual, company, society): Merz

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
Yes
Please specify entities (individual, company, society): Merz

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work is presented thanks to the support of: Merz

Objectives: Provide an overview of Nuceiva (Jeuveau in US) pivotal trial results, newly published data and a longer duration formulation results.

Introduction: Introduced over 20 years ago, botulinum toxin (Type A) continues to be the dominant aesthetic injectable treatment choice for patients. Nuceiva (Jeuveau in US, Evolus, Newport Beach, California) is FDA approved and was cleared in the EU through the centralized process and is now expanding its commercial launch into Europe.

Materials / method: A literature review of the pivotal trial results is provided, as well as the results of recently released data comparing Nuceiva in males, millennials and a longer duration formulation utilizing 40Units.

Results: The European/Canadian Phase III studies demonstrated non-inferiority of Jeuveau compared to Botox with the responder rates at one month of 82.8% for Botox and 87.7% for Nuceiva. Publications have also demonstrated positive results in males, with onset at 2 days for Nuceiva and responder rates at 150 days of 19.4% for Botox and 40% for Nuceiva. A Phase II study utilizing 40U of Nuceiva has demonstrated 26 weeks duration of effect.

Conclusion: Nuceiva (Jeuveau) is FDA and EMA approved and has demonstrated non-inferiority against Botox in pivotal. New publications have demonstrated efficacy in males and millennials, and a 40U dose has demonstrated 26 weeks of duration.

Disclosures

Did you receive any funding to support your research for this TOPIC?
Yes
Please specify entities (individual, company, society): Evolus

Were you provided with any honoraria, payment or other compensation for your work on this study?
Yes
Please specify entities (individual, company, society): Evolus employee

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
Yes
Please specify entities (individual, company, society): Evolus employee

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work is presented thanks to the support of: Evolus

Disclosures

Did you receive any funding to support your research for this TOPIC?
No

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work was not supported by any direct or non direct funding. It is under the author's own responsability

Disclosures

Did you receive any funding to support your research for this TOPIC?
No

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work is presented thanks to the support of: medytox

Objectives: To demonstrate the efficacy and safety of ATGC-110 in the treatment of subjects with moderate-to-severe glabellar lines (GLs).

Introduction: This was a multicenter, randomized, double-blind, active-controlled, non-inferiority, phase 3 clinical trial comparing the efficacy and safety of 20 units (U) of ATGC-110 and 20 U of incobotulinumtoxinA in the treatment of subjects with moderate-to-severe GLs.

Materials / method: Baseline (BL) and post-treatment assessments were made using a validated 4-point facial wrinkle scale (FWS), a 9-point subject global assessment of change scale (GACS), and a 7-point subject satisfaction assessment scale (SSAS). Primary efficacy was assessed for the per protocol set (PPS) at Week 4 and was the proportion of subjects with 0 (none) or 1 (mild) on the FWS at maximum frown and improvement of at least 2-points from BL based on the investigator’s live assessment. Secondary efficacy endpoints and adverse events also were assessed.

Results: Subjects (N=298) had a mean (SD) age of 48.6 (8.77) years and were mostly female (79.9%) and moderate (63.1%) in GL severity at BL. For ATGC-110 subjects, 85.1% were responders on the primary endpoint compared to 68.1% for incobotulinumtoxinA subjects (p=0.0010). The difference of proportion [95% CI] was 0.17 [0.06, 0.27]; CI lower bound exceeded the non-inferiority margin of -0.15. Additional efficacy results to be reported to Week 16. Treatment-emergent adverse events (TEAEs) were mostly mild and occurred at similar frequencies among ATGC-110 (9.4%) and incobotulinumtoxinA (6.6%) subjects.

Conclusion: ATGC-110 is a novel, investigational, 150 kDa botulinum neurotoxin type A drug product, free of neurotoxin associated proteins (NAPs). In this Korean phase 3 trial, ATGC-110 significantly reduced GL severity and was associated with a favorable safety profile. ATGC-110 was shown to be non-inferior to incobotulinumtoxinA in the treatment of moderate-to-severe GLs at Week 4.

Disclosures

Did you receive any funding to support your research for this TOPIC?
No

Were you provided with any honoraria, payment or other compensation for your work on this study?
Yes
Please specify entities (individual, company, society): I am an employee of Sinclair

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work is presented thanks to the support of: Sinclair and ATGC Co., Ltd

Disclosures

Did you receive any funding to support your research for this TOPIC?
No

Were you provided with any honoraria, payment or other compensation for your work on this study?
Yes
Please specify entities (individual, company, society): employee of companry

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
Yes
Please specify date...: Pending
and status : patent for some data

This work was not supported by any direct or non direct funding. It is under the author's own responsability