GALDERMA
28.3.2022 15:12:06 CEST | Business Wire | Press release
Galderma will present a range of new scientific data on its portfolio on their hyaluronic acid dermal filler range, their first liquid neuromodulator and their original collagen biostimulator at the Aesthetic & Anti-Aging Medicine World Congress (AMWC) taking place in Monaco and virtually from 31 March to 2 April 2022.
Dr Philippe Kestemont will present an overview of clinical data for Alluzience®, Galderma’s recently approved and Europe’s first ready-to-use liquid neuromodulator for the treatment of moderate to severe glabellar (frown) lines.1
Pooled data from two Phase III studies (NCT02353871 and NCT02493946) show that Alluzience® successfully improved glabellar lines regardless of severity with rapid onset and results lasting up to 6 months.2,3 Improvements in GL severity, satisfaction and psychological wellbeing were also consistent over several cycles of treatment with Alluzience®.2,3
The latest long-lasting efficacy and safety results will also be presented on the new formulation of Sculptra®, the original and only poly-L-lactic acid (PLLA) approved by the FDA. The new constitution means it can be reconstituted to 5ml or 8ml, used immediately and an optional 1mL of lidocaine can be added for patient comfort. The open-label extension study evaluating the new formulation of 8mL showed Sculptra® was well tolerated and had a long-lasting duration of effect, with subject satisfaction up to 96 weeks.4
“We are proud to sponsor the Aesthetics & Anti-Aging Medicine World Congress 2022 and we look forward to engaging with the aesthetics community, both in person in Monaco and virtually.
At Galderma, we believe in the benefits of delivering individualized aesthetics results. We are excited to host a symposium to bring this vision to the aesthetics community and share new data with a series of posters in our drive for innovation across our aesthetics portfolio.”
– Flemming Ørnskov, MD, MPH, Chief Executive Officer, Galderma
Galderma will also present data demonstrating the effectiveness and high patient satisfaction in patients treated with hyaluronic acid fillers. Results from Dr Andreas Nikolis’ CHEEKY post-market study evaluated treatment with Restylane® Lyft™ for those needing a projection effect and Restylane® Volyme™ for a contouring/volumizing effect.5
In addition, Dr Steven Dayan will detail positive results from a post-marketing study evaluating facial harmony and patient satisfaction after treatment with Restylane® Defyne™, a flexible hyaluronic acid filler, using a stepwise treatment approach.6
Finally, at AMWC, Galderma will be hosting a symposium that has been developed with some of the world’s most talented aesthetic physicians. Focusing on ‘A New Patient Centric Approach to turn your AART™ into a HIT™, the Galderma symposium will focus on how to use AART™ – Anatomy, Assessment, Regimen and Therapy – to deliver a Holistic Individualized Treatment (HIT) for each patient.
Moderated by Dr Andreas Nikolis (Canada), the symposium will feature interactive sessions with Sebastian Cotofana (US), Kay Durairaj (USA), Christoph Martschin (Sweden), Marcus Morais (Brazil) and Frank Rosengaus (Mexico), as well as live injections and a panel assessment.
The complete list of the new clinical data that Galderma and independent researchers will present is below:
Treatment |
Poster |
Number |
Alluzience® |
Ready-to-use liquid abobotulinumtoxinA for treatment of glabellar lines: An overview of available clinical data |
#3735 |
Sculptra® |
An open-label extension study to evaluate safety and effectiveness of a biostimulatory poly-L-lactic acid injectable implant after changes in reconstitution and injection procedure |
#3802 |
Restylane® Lyft™ Restylane® Volyme™ |
The CHEEKY Study: effectiveness of cheek treatment with hyaluronic acid fillers HA-VOL and HA-LYF |
#3719 |
Restylane® Defyne™ |
A randomized, post-marketing study to evaluate facial harmony and subject satisfaction after treatment with HA-DEF using a stepwise treatment approach |
#3730 |
For more information, the AMWC 2022 program is available here .
About Galderma
Galderma is the world’s largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine.
Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we’re in shapes our life stories, we are advancing dermatology for every skin story. For more information: www.galderma.com .
About Alluzience® (liquid botulinum toxin type A)
Alluzience® (liquid botulinum toxin type A) is the first ready-to-use BoNT-A liquid neuromodulator formulation to be introduced in Europe. Alluzience® should only be administered by a physician with appropriate qualifications and expertise in this treatment using the required equipment.1
Dosing and treatment intervals depend on assessment of the individual patient’s response.1
The treatment interval should be no more frequent than every three months.1
For more information, please see the Summary of Product Characteristics.1
Alluzience® is a product under license from Ipsen. Alluzience® is a registered trademark of Ipsen. Galderma has an exclusive license from Ipsen to develop, promote and distribute Alluzience® in the approved indication in Europe (excluding Czech Republic, Slovakia, Greece, Lithuania, Estonia, Latvia, Hungary).
About Sculptra®:
SCULPTRA® works to stimulate the skin’s own collagen production7
and is suitable for increasing the volume of depressed areas, particularly to correct skin depressions such as skin creases, wrinkles, folds and scars, and for signs of skin aging.8
SCULPTRA is also suitable for large volume corrections of the signs of facial fat loss (lipoatrophy).8
SCULPTRA® is an injectable biostimulator containing microparticles of poly-L-lactic acid (PLLA) which gradually revitalizes the skin’s structural foundation, providing natural-looking, long-term results for up to 25 months.7,9 SCULPTRA was first approved in 1999 in Europe and it is currently available in more than 40 countries globally.
About Galderma’s Restylane portfolio
RESTYLANE is the original non-animal stabilized hyaluronic acid filler with over 25 years of achievement and over 50 million treatments worldwide.10
NASHA™ and OBT™ technologies make RESTYLANE the world’s most diverse range of fillers to deliver truly individualized results.11.12
The RESTYLANE portfolio of products includes RESTYLANE, RESTYLANE LYFT, RESTYLANE KYSSE, RESTYLANE VOLYME, RESTYLANE DEFYNE, RESTYLANE REFYNE, RESTYLANE EYELIGHT and RESTYLANE SKINBOOSTERS.
References:
- Summary of Product Characteristics, 10 June 2021.
- Ascher et al. Aesthet Surg J 2020;40:93-104.
- Kestemont et al. Aesthet Surg J 2021;Sep 2;sjab329.
- Prather et al. Poster #3802 to be presented at AMWC 2022.
- Nikolis A., Poster #3719 to be presented at AMWC 2022.
- Dayan S., Poster #3730 to be presented at AMWC 2022.
- Bohnert K et al. Plast Reconstr Surg 2019;127(4):1684–92.
- Sculptra IFU. 2018.
- Brown SA et al. Plast Reconstr Surg 2011;127(4):1684–92.
- Data on file (MA-39680).
- Data on file (MA-33939).
- Öhrlund A., Poster presented at AMWC 2019.
Prescribing information, trademarks and registration status may vary depending on local approval in each country. Always refer to local materials such as the prescribing information and/or the Summary of Product Characteristics (SPC)
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