DailyMed – BOTOX COSMETIC- onabotulinumtoxina injection, powder, lyophilized, for solution

12
DailyMed – BOTOX COSMETIC- onabotulinumtoxina injection, powder, lyophilized, for solution


14.1
     
Glabellar Lines

Two randomized, multi-center, double-blind, placebo-controlled studies of identical design were conducted to evaluate BOTOX Cosmetic for use in the temporary improvement of the appearance of moderate to severe glabellar facial lines. The studies enrolled healthy adults (ages 18 to 75) with glabellar lines of at least moderate severity at maximum frown. Subjects were excluded if they had ptosis, deep dermal scarring, or an inability to substantially lessen glabellar lines even by physically spreading them apart. Subjects received a single treatment with BOTOX Cosmetic (N=405, combined studies) or placebo (N=132, combined studies). Injection volume was 0.1 mL/injection site, for a dose/injection site in the active treatment groups of 4 Units. Subjects were injected intramuscularly in five sites, 1 in the procerus muscle and 2 in each corrugator supercilii muscle, for a total dose in the active treatment groups of 20 Units.

The co-primary efficacy endpoints were the investigator’s rating of glabellar line severity at maximum frown and the subject’s global assessment of change in appearance of glabellar lines, both at Day 30 post-injection. For the investigator rating, using a 4-point grading scale (0=none, 3=severe) a responder was defined as having a severity grade of 0 or 1. For the subject’s global assessment of change, the ratings were from +4 (complete improvement) to -4 (very marked worsening). A responder was defined as having a grade of at least +2 (moderate improvement). After completion of the randomized studies, subjects were offered participation in an open label, repeat treatment study to assess the safety of repeated treatment sessions.

The combined results of these two efficacy studies are presented here. The mean age was 46 years, with 32 subjects (6%) ≥65 years of age. Most of the subjects were women (82%), and Caucasian (84%). At baseline, 210 subjects (39%) had glabellar line severity scores at rest of moderate or severe.

In these studies, the severity of glabellar lines was reduced for up to 120 days in the BOTOX Cosmetic group compared to the placebo group as measured both by investigator rating of glabellar line severity at maximum frown (Table 5), and by subject’s global assessment of change in appearance of glabellar lines (Table 6).

a 95% confidence intervals are shown in parenthesis

b Day 30: Co-Primary Efficacy Time point, p<0.001

a 95% confidence intervals are shown in parenthesis

b Day 30: Co-Primary Efficacy Time point, p<0.001

In the subset of subjects with resting severity scores of moderate or severe, the investigator assessment of a resting severity of mild or none at Day 30 was also achieved by more BOTOX Cosmetic treated subjects (74%, 119/161) than placebo treated subjects (20%, 10/49).

Analysis of the limited number of subjects 65 years or older suggested a lower treatment-associated response compared to subjects less than 65 years of age (Table 7).

a 95% confidence intervals are shown in parenthesis

Exploratory analyses by gender suggested that responder rates in the BOTOX Cosmetic treated group were higher for women than for men for both the investigator assessment (Day 30; 85% of 334 women, 59% of 71 men) and the Subject Assessment (Day 30; 93% of women, 72% of men). In the limited number of non-Caucasian subjects (n=64 in the BOTOX Cosmetic treated group) the responder rates were similar to those observed in the Caucasian subjects.

14.2
     
Lateral Canthal Lines

Two  multicenter, randomized, double-blind, placebo-controlled studies evaluated BOTOX Cosmetic (N=833, randomized to receive any BOTOX Cosmetic treatment or N=529 randomized to receive placebo) for the temporary improvement in the appearance of moderate to severe lateral canthal lines (LCL). Study 1 assessed BOTOX Cosmetic treatment of LCL alone; Study 2 also assessed simultaneous treatment of LCL and glabellar lines (GL). Both studies enrolled healthy adults with moderate to severe LCL at maximum smile at baseline; Study 2 also required subjects to have moderate to severe GL at maximum frown at baseline.

In the 5-month Study 1, subjects were randomized to receive a single blinded treatment of 24 Units/0.6 mL (12 Units per side) consisting of 4 Units/0.1 mL into 3 sites of each orbicularis oculi muscle with either BOTOX Cosmetic (N=222) or placebo (N=223).

In the 7-month Study 2, subjects were randomized to receive either BOTOX Cosmetic in the LCL region and placebo in the GL region (24 Units; N=306), or BOTOX Cosmetic in the LCL and GL regions (44 Units [24 Units for LCL and 20 Units for GL]; N=305), or placebo in the LCL and GL regions (0 Units; N=306). Subjects received the same 24 Units regimen for LCL as in Study 1, and the labeled 20 Units (5 injections, 4 Units per site) for GL. Subjects received the same treatment at days 1 and 120.

The primary efficacy measure was the assessment of LCL severity at maximum smile using the 4-point Facial Wrinkle Scale with Photonumeric Guide (FWS; 0=none, 1= mild, 2=moderate, 3=severe). The FWS assessment was performed independently by both investigators and subjects. The primary timepoint was day 30 following the first treatment, as compared to baseline.

The primary efficacy response definition was a composite ≥2-grade improvement from baseline in LCL severity at maximum smile, assessed by both investigator and subject on a per-subject basis. For Studies 1 and 2, the proportion of responders was statistically significant favoring BOTOX Cosmetic (24 Units [LCL alone] and 44 Units [LCL and GL]) compared to placebo at day 30 (Table 8).

The secondary endpoint of a responder defined as achieving a grade of none or mild for Study 1 as measured by the investigator is presented in Figure 5 below.

Figure 5: Percentage of Subjects with Treatment Success (% of Subjects achieving None or Mild from Baseline) by Visit (Study 1)

DailyMed – BOTOX COSMETIC- onabotulinumtoxina injection, powder, lyophilized, for solution

14.3
     
Forehead Lines

Two multicenter, randomized, double-blind, placebo-controlled studies evaluated BOTOX Cosmetic (N=921, randomized to receive any BOTOX Cosmetic treatment or N=257, randomized to receive placebo) for the temporary improvement in the appearance of moderate to severe forehead lines (FHL).

Study 1 assessed BOTOX Cosmetic treatment of FHL with glabellar lines (GL); Study 2 also assessed simultaneous treatment of FHL, GL, and lateral canthal lines [LCL]. Both studies enrolled healthy adults with moderate to severe FHL at maximum eyebrow elevation at baseline and moderate to severe GL at maximum frown at baseline; Study 2 also required subjects to have moderate to severe LCL at maximum smile at baseline.

In the 12-month Study 1, subjects were randomized to receive BOTOX Cosmetic 20 Units to the frontalis muscle with 20 Units to the glabellar region (for a total of 40 Units) or placebo in both areas.

In the 12-month Study 2, subjects were randomized to receive BOTOX Cosmetic 20 Units to the frontalis muscle, 20 Units to the glabellar region, and 0 Units to the LCL region (for a total of 40 units) or BOTOX Cosmetic 20 Units to the frontalis muscle, 20 Units to the glabellar region, and 24 Units to the LCL region (for a total of 64 Units) or placebo in all three areas.

The primary efficacy measure was the assessment of FHL severity at maximum eyebrow elevation using the 4-point Facial Wrinkle Scale with Photonumeric Guide (FWS; 0=none, 1= mild, 2=moderate, 3=severe). The FWS assessment was performed independently by both investigators and subjects. The primary timepoint was Day 30 following the first treatment.

The primary efficacy response definition was a composite ≥2-grade improvement from baseline in FHL severity at maximum eyebrow elevation, assessed by both investigator and subject on a per-subject basis. For Studies 1 and 2, the proportion of responders was greater in the BOTOX Cosmetic arms compared to placebo at Day 30 (p<0.0001 for Studies 1 and 2) (Table 9).

A total of 165 and 197 subjects received 3 cycles over 1 year of BOTOX Cosmetic 40 Units (20 Units FHL with 20 Units GL) and 64 Units (20 Units FHL, 20 Units GL, and 24 Units LCL), respectively. The response rate for FHL was similar across all treatment cycles.

The results for a key secondary endpoint of responders achieving a grade of none or mild on investigator ratings at maximum eyebrow elevation of FHL severity are presented below for Studies 1 and 2.

Figure 6: Percentage of Subjects with Treatment Success (Achieving None or Mild FHL from Baseline at Maximum Eyebrow Elevation) by Visit (Study 1)

Figure 6: Percentage of Subjects with Treatment Success (Achieving None or Mild FHL from Baseline at Maximum Eyebrow Elevation) by Visit (Study 1)

Figure 7: Percentage of Subjects with Treatment Success (Achieving None or Mild FHL from Baseline at Maximum Eyebrow Elevation) by Visit (Study 2)

Figure 7: Percentage of Subjects with Treatment Success (Achieving None or Mild FHL from Baseline at Maximum Eyebrow Elevation) by Visit (Study 2)

The results of the Facial Line Satisfaction Questionnaire are presented in Table 10.


Disasters Expo USA, is proud to be supported by Inergency for their next upcoming edition on March 6th & 7th 2024!

The leading event mitigating the world’s most costly disasters is returning to the Miami Beach

Convention Center and we want you to join us at the industry’s central platform for emergency management professionals.
Disasters Expo USA is proud to provide a central platform for the industry to connect and
engage with the industry’s leading professionals to better prepare, protect, prevent, respond
and recover from the disasters of today.
Hosting a dedicated platform for the convergence of disaster risk reduction, the keynote line up for Disasters Expo USA 2024 will provide an insight into successful case studies and
programs to accurately prepare for disasters. Featuring sessions from the likes of The Federal Emergency Management Agency,
NASA, The National Aeronautics and Space Administration, NOAA, The National Oceanic and Atmospheric Administration, TSA and several more this event is certainly providing you with the knowledge
required to prepare, respond and recover to disasters.
With over 50 hours worth of unmissable content, exciting new features such as their Disaster
Resilience Roundtable, Emergency Response Live, an Immersive Hurricane Simulation and
much more over just two days, you are guaranteed to gain an all-encompassing insight into
the industry to tackle the challenges of disasters.
By uniting global disaster risk management experts, well experienced emergency
responders and the leading innovators from the world, the event is the hub of the solutions
that provide attendees with tools that they can use to protect the communities and mitigate
the damage from disasters.
Tickets for the event are $119, but we have been given the promo code: HUGI100 that will
enable you to attend the event for FREE!

So don’t miss out and register today: https://shorturl.at/aikrW

And in case you missed it, here is our ultimate road trip playlist is the perfect mix of podcasts, and hidden gems that will keep you energized for the entire journey

-

This website uses cookies to improve your experience. We'll assume you're ok with this, but you can opt-out if you wish. Accept Read More