Galderma to Present Extensive New Clinical Data Across Its Portfolio of Neuromodulators, Fillers and Biostimulators at the IMCAS World Congress 2022

• Strong clinical data supporting Alluzience^® (abobotulinumtoxinA, ABO), the first liquid, ready-to-use neuromodulator as an effective and well-tolerated treatment for glabellar (frown) lines, with a rapid onset and long duration of action of up to six months

• Data confirming that Dysport^® was consistently efficacious for the treatment of frown lines, was well tolerated and had a fast onset of effect across three trials with high patient satisfaction reported up to 6 months after injection in phase III trials

• Phase IV data confirming the effectiveness and natural-looking effects with the Restylane^® range of hyaluronic acid fillers, with all patients achieving the aim of their treatment, whether it was projection or contouring/volumization with results that were natural-looking with high subject satisfaction

• Presentation of the latest extension study for Sculptra^®, the original poly-L-lactic acid (PLLA) which demonstrated it to be well-tolerated and with long-lasting effectiveness until week 96 using reconstituted 8mL dilution.

(BUSINESS WIRE) -- Galderma will present a range of new clinical data and analyses across its portfolio during nine poster sessions and two symposia at the upcoming International Master Course on Aging Science (IMCAS) World Congress 2022 in Paris from June 3-5, 2022.

Latest efficacy, safety & satisfaction data for neuromodulator portfolio

Alluzience

Two oral presentations and a poster will center on data for Alluzience, the first ready to use liquid (abobotulinumtoxinA), approved in June 2021 in Europe. Pooled data from two phase III studies (NCT02353871 and NCT02493946) demonstrated that Alluzience effectively improved frown line severity, with rapid onset of effect and up to 6 months improvement after a single treatment.^1-3 Improvements in the severity of frown lines, satisfaction and psychological well-being were maintained over repeated treatment cycles.¹ Additional post-hoc analyzes will be presented that confirm that the median time to return to baseline rating was nearly six months.³

The clinical data that will be presented are listed below:

Delegates at IMCAS can also attend Galderma’s symposium, Alluzience: the first liquid neuromodulator – from theory to practice. During the session, an expert panel will take attendees on a journey through the science of the first ready-to-use neuromodulator and their clinical experience of the breakthrough treatment. The symposium is taking place on Saturday 4, 13:30 to 15:00 CET.

Dysport (also marketed as Azzalure^® in the EU)

Clinical experience with Dysport (abobotulinumtoxinA) spans over three decades* and it has a well-established safety profile across multiple aesthetic indications including both frown lines and crow’s feet.^4–14

Researchers will present three posters demonstrating that Dysport is efficacious and well tolerated, with subjects reporting natural results and high rates of satisfaction. A dose escalation study evaluated subject satisfaction using abobotulinumtoxinA doses up to 125U and demonstrated it was efficacious and well-tolerated across all doses from 50U to 125U with high satisfaction and improvement maintained for up to 9 months.¹⁵ Data was analyzed from three studies (NCT03736928, Phase 2; NCT03960957, Phase 3; NCT03687736, Phase 4) in which all subjects were treated with on-label 50 units. Subjects reported median onset of effect after two days in all three trials and high rates of subject satisfaction up to six months after injection in phase III and nine months in phase II trials.¹⁶ A post-hoc analysis of clinical trial NCT03687736 also found that while all age groups were satisfied with and experienced psychological benefits from treatment, millennials, known for their high expectations appeared to be particularly happy with two treatments a year of abobotulinumtoxinA.¹⁷

The clinical data that will be presented are listed below:

*Approved for therapeutic use in December 1990 and aesthetic use in April 2009

New data for Restylane range of hyaluronic acid fillers

Restylane

One of the oral presentations presented will report on phase IV data from the CHEEKY study which evaluated treatment outcome after providing investigators with a treatment guide to help choose the right treatment for their patient. The study demonstrated that all patients achieved the aim of their treatment, whether it was projection or contouring/volumization and that the results were natural-looking with high subject satisfaction.¹⁸

The clinical data that will be presented are listed below:

96 Week Data for Collagen Biostimulator

Sculptra

The latest long-term effectiveness and safety of Sculptra, the original and only poly-L-lactic acid (PLLA) approved by the FDA, will also be presented at IMCAS 2022. In this extension study for the correction of nasolabial folds, Sculptra, using the new constitution of 8 ml with 1 ml lidocaine, showed it to be well-tolerated and with long-lasting effectiveness until week 96.¹⁹

The clinical data that will be presented is shown below:

Participants are also invited to attend the symposium, Restylane and Sculptra: Predictive Lessons from generations applied to facial rejuvenation, taking place on Saturday June 4, 08:30 to 10:00 CET. The symposium will see leading physicians offer their insights into how assessing people within the same family at different stages of their life can inform the design of holistic individualized treatments for patients.

For more information, the IMCAS 2022 program is available here.

About Galderma

Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market though Injectable Aesthetics, Dermo-cosmetics and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, 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.²⁰ Dosing and treatment intervals depend on assessment of the individual patient’s response.²⁰ The treatment interval should be no more frequent than every three months.²⁰ For more information, please see the Summary of Product Characteristics.²⁰

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 Greece, Lithuania, Estonia, Latvia, Hungary).

About Dysport®

Dysport (abobotulinumtoxinA) is a prescription injection for temporary improvement in the appearance of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age. Dysport is also marketed as Azzalure in the EU for the treatment of glabellar lines and lateral canthal lines. Dysport has more than 30 years of clinical experience Globally for therapeutic indications and 13 years for aesthetics indications, with extensive clinical evidence of safety and efficacy. It is licensed for aesthetic indications in 85 markets worldwide, Dysport is one of the world’s leading brands of aesthetic neuromodulators with over 100 million treatments delivered in the aesthetics indications to date.

Dysport is a product under license from Ipsen and is manufactured by them. Since 2009, Galderma and Ipsen have had a strategic partnership under which Galderma has promoted and distributed Ipsen’s botulinum toxin type A products in aesthetic indications. The Ipsen-Galderma strategic partnership now covers China, the United States, Europe and the Middle East, Australia, South Korea, Canada, Brazil, Argentina and certain other countries. Ipsen continues to promote Dysport within certain therapeutic indications in countries around the world. For more information on Ipsen, visit www.ipsen.com.

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. NASHA™ and OBT™ technologies make RESTYLANE the world’s most diverse range of fillers to deliver truly individualized results.^21,22

The RESTYLANE^® portfolio of products includes RESTYLANE^®, RESTYLANE^® LYFT^TM, RESTYLANE^® KYSSE^TM, RESTYLANE^® VOLYME^TM, RESTYLANE^® DEFYNE^TM, RESTYLANE^® REFYNE^TM, RESTYLANE^® EYELIGHT^TM and RESTYLANE^® SKINBOOSTERS VITAL^TM.

About Sculptra^®

SCULPTRA works to stimulate the skin’s own collagen production²³ 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.²⁴ SCULPTRA is also suitable for large volume corrections of the signs of facial fat loss (lipoatrophy).²⁴

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.²⁵ SCULPTRA was first approved in 1999 in Europe and it is currently available in more than 40 countries globally.

References:

1. Ascher B. Poster #113846 to be presented at IMCAS 2022.

2. Picaut, P. Oral Presentation #114879 to be presented at IMCAS 2022.

3. Rzany B. Oral Presentation #114895 to be presented at IMCAS 2022.

4. Kane AC et al. Plast Reconstr Surg 2009;124:1619–29.

5. Dysport Summary of Product Characteristics, Galderma, July 2018.

6. Brandt F et al. Dermatol Surg 2009;35:1893–1901.

7. Moy RM et al. Arch Facial Plast Surg 2009;11(2):77–83.

8. Rubin MG et al. J Drugs Dermatol 2009;8(5):439–444.

9. Schlessinger J et al. Dermatol Surg 2014;40(2):176–183.

10. Maas C et al. Aesthet Surg J 2012;32(1S):8S–29S.

11. Cohen JL and Scuderi N. Aesthet Surg J 2017;37(S1):S33–S44.

12. Hexsel D et al. Dermatol Surg 2018;44(12):1555-1564.

13. Rubin M et al. Aesthet Surg J 2009;29:S50–S56.

14. Cohen JL et al. Aesthet Surg J 2009;29(Suppl 1):S43–S49.

15. Dayan S et al. Poster #114887 to be presented at IMCAS 2022.

16. Dayan S et al. Poster #114885 to be presented at IMCAS 2022.

17. Prygova I et al. Poster #114945 to be presented at IMCAS 2022

18. Nikolis A et al. Oral Presentation #114864 to be presented at IMCAS 2022.

19. LaTowsky B et al. Oral Presentation #114971 to be presented at IMCAS 2022.

20. Summary of Product Characteristics, 10 June 2021.

21. Data on file (MA-33939).

22. Öhrlund A. Poster presented at AMWC 2019.

23. Bohnert K et al. Plast Reconstr Surg 2019;127(4):1684–92.

24. Sculptra IFU. 2018.

25. Brown SA et al. Plast Reconstr Surg 2011;127(4):1684–92.

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