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?
Yes
Please specify entities (individual, company, society): CEO of Eirion

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...: Multiple patents issued and applied for
and status : Multiple patents issued qnd qpplied for

This work is presented thanks to the support of: Eirion conducted the research

Objectives: Using a Phase II, multicenter, randomized, double-blind, active-controlled study design, to investigate both the safety of a single treatment of 40U of the injectable neuromodulator, prabotulinumtoxinA-xvfs (administered as 5 injections, 0.05 mL (8U) per injection), and its duration of effect in providing temporary improvement in the appearance of moderate to severe glabellar lines in adult subjects, as measured at maximum frown on the 4-point Glabellar Line Scale (GLS: 0=none, 1=mild, 2=moderate, 3=severe).

Introduction: Since first introduced over 20 years ago, injectable botulinum toxins (type A) have become the standard of care for the temporary improvement in the appearance of moderate to severe glabellar lines. However, at approved doses, a maximum effect is typically achieved within 30 days; the duration of effect then wanes over the next 3-4 months. Not surprisingly, there has been considerable interest in investigating higher doses of these toxins as a means to increase their duration of effect. In 2019, prabotulinumtoxinA

Materials / method: 154 adults with moderate to severe glabellar lines were randomized 1:1:1 to a single treatment of either 40U prabotulinumtoxinA-xvfs (PRA 40), 20U prabotulinumtoxinA-xvfs (PRA 20) or 20U onabotulinumtoxinA (ONA 20), where each 20U dose was administered as 5 injections, 0.1 mL (4U) per injection. Safety and effectiveness outcomes were assessed up until the subject had returned to their baseline GLS score. The primary endpoint was the duration of effect, defined as the number of days from Treatment Day to the day that GLS severity at maximum frown by Investigator assessment returned to Baseline.

Results: No serious, severe or unexpected adverse events were reported. No seroconversions were evident with the 40U dose. The median number of days from Treatment Day to the day that GLS severity at maximum frown returned to Baseline was 183, 149 and 148 days for each of the PRA 40, PRA 20 and ONA 20 groups, respectively. The difference in the durations of effect between PRA 40 and PRA 20, derived by comparing the two Kaplan-Meier survival curves, was statistically significant: adjusted hazard ratio of 1.892; p=0.0109. The adjusted hazard ratio between PRA 40 and ONA 20 was 2.38; p=0.0002.

Conclusion: A doubled-dose 40U hyper-concentrated formulation of prabotulinumtoxinA-xvfs was safe and effective for the treatment of moderate to severe glabellar lines in adult subjects, with a median duration of effect of 6 months

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): 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): PAID BY EVOLUS

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?
Yes
Please specify entities (individual, company, society): Fastox Pharma

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

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): Fastox Pharma

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 : 2019

This work is presented thanks to the support of: Fastox Pharma

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: REVANCE

Disclosures

Did you receive any funding to support your research for this TOPIC?
Yes
Please specify entities (individual, company, society): Daewoong 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: I received honorarium for this lecture from Daewoong company

Objectives: In this presentation, we will review the recent clinical trial results of Letybo® and discuss the implications of these findings.

Introduction: Letybo® (Letibotulinumtoxin A) is a proprietary formulation of highly purified 900 kDa Clostridium botulinum type A neurotoxin complex manufactured by Hugel Inc. in South Korea. Letybo® was first approved by the KDFA in 2009 and has since expanded its market beyond Asia to the global market.

Materials / method: First, in the international, multi-center, phase 3 clinical trial (BLESS III) for the treatment of glabellar frown lines, the psychological impact of Letybo® was evaluated and compared to a placebo. At Week 4, Letybo® showed significant improvements in the Modified Skindex-16 GL-QoL Scale (absolute change of overall mean score[SD] from baseline; -38.4[31.08] vs. -0.7[22.37]). Additionally, the Letybo® group perceived themselves to be significantly younger and were satisfied with the treatment results.

Results: Secondly, a phase 3 clinical trial evaluated the efficacy and safety of Letybo® compared to Onabotulinumtoxin A for treating glabella wrinkles in the Asian population. At Week 4, when evaluating the proportion of patients who scored 0 or 1 on the 4-point photographic evaluation scale, Letybo® demonstrated non-inferiority to Onabotulinumtoxin A (at maximum frown; 88.49% vs. 87.39%, 95% CI, -5.02–8.82; p=0.7469) and had a comparable safety profile.

Conclusion: Lastly, the efficacy and safety of Letybo® 24U, 48U, 72U, and 96U in treating masseter hypertrophy were assessed in a phase 2 clinical trial conducted in South Korea. Over 16 weeks, all dosage groups of Letybo® demonstrated statistically significant reductions in masseter muscle thickness and lower facial volume compared to the placebo. Furthermore, considering the clinical significance and cost-effectiveness, a dosage of 48U is the most appropriate.
The aforementioned results support the safety and efficacy of Letybo® for aesthetic purposes

Disclosures

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

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

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): Hugel Pharma

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: Hugel Pharma