GALDERMA

Galderma today announced new results from its robust pipeline and portfolio of dermal fillers and toxin injections. Eleven e-posters from Galderma-sponsored and investigator-initiated trials have been accepted at the upcoming Aesthetic & Anti-Aging Medicine World Congress (AMWC), taking place in Monaco and virtually on September 16–18, 2021.

Data for SCULPTRA^® (injectable poly-L-lactic acid) will explore the effectiveness and safety of two different dilutions (8mL versus 5mL) at 48 weeks for the correction of nasolabial fold wrinkles. Earlier this year, the administration procedure for SCULPTRA was updated in Europe, allowing for higher reconstitution volumes of 5-8mL (previously 5mL). These latest results serve to support the new protocol, which offers a faster and more convenient approach to injecting dermal fillers.

Further data will evaluate the effectiveness and safety of ALLUZIENCE^® (liquid botulinum toxin type A) versus placebo after six months for the correction of glabellar (frown) lines. All currently approved botulinum toxin type A products in Europe come in powder form and require reconstitution before use.¹ ALLUZIENCE—the first ready-to-use liquid formulation licensed in Europe—has been designed to deliver outstanding precision and performance, with a formulation developed using innovative new production technologies.^1,2

“Our strong presence at AMWC this year underscores our unwavering commitment to driving aesthetics innovation. We understand that everyone’s skin is unique, and we embrace these differences to offer cutting-edge treatments that make people look and feel great. As we advance dermatology for every skin story, we are excited to be delivering novel solutions across our portfolio.”

FLEMMING ØRNSKOV, M.D., MPH
CHIEF EXECUTIVE OFFICER
GALDERMA

Taking the opportunity to engage with a variety of aesthetics and anti-aging experts, Galderma will host a sponsored symposium on Thursday, September 16, 2021, from 14:00-16:00 CEST in the prestigious Prince Pierre Auditorium. The interactive session, First Impressions – From Theory to Practice , will involve assessment with patient pictures, audience participation and live injections, led by a panel of multidisciplinary speakers covering the nose, skin and lips. More information and access to the event will be available to all registered congress participants.

The sponsored symposium will be followed on Friday, September 17, 2021, with a bespoke event, For Your Eyes Only , to launch RESTYLANE^® EYELIGHT^™ , a new solution to combat under-eye shadows. The under-eye region is one of the first parts of the face to show signs of aging. This makes RESTYLANE EYELIGHT a major milestone for helping people look less tired and more rested, in addition to helping them feel their best.^3,4 From 18:30-20:30 CEST, a world-renowned faculty will deliver an interactive agenda exploring the new opportunity and value of RESTYLANE EYELIGHT to clinical practice. Access to the event is invitation-only.

Additional data showcasing the strength and depth of Galderma’s pipeline and portfolio will be available throughout AMWC 2021. The complete list of 11 e-posters that have been accepted for presentation are:

Treatment	E-poster	Number
SCULPTRA	A randomized study on safety and effectiveness of a biostimulatory poly-L-lactic acid injectable implant after changes in reconstitution – Palm M., et al.	Abstract #2343
ALLUZIENCE	Treatment of moderate-to-severe glabellar lines using ready-to-use liquid abobotulinumtoxinA: Pooled data from two double-blind, randomized, placebo-controlled Phase III studies – Kestemont P., et al.	Abstract #2340
ALLUZIENCE	Long-lasting improvement of glabellar lines using ready-to-use liquid abobotulinumtoxinA: Post hoc analysis of a double-blind, randomized, placebo-controlled Phase III study – Kestemont P., et al.	Abstract #2341
DYSPORT®**	A randomized, double-blind, placebo-controlled study of a new dilution and injection volume of abobotulinumtoxinA for treatment of glabellar lines – Schlessinger J., et al.	Abstract #2324
DYSPORT	A randomized, dose-escalating, double-blind study to evaluate abobotulinumtoxinA for the treatment of moderate-to-severe glabellar lines – Joseph J., et al.	Abstract #2462
DYSPORT	Subject satisfaction with abobotulinumtoxinA for moderate-to-severe glabellar lines: A randomized, dose-escalating, double-blind study – Dayan S., et al.	Abstract #2461
DYSPORT	Subject-relevant outcomes of on-label 50U abobotulinumtoxinA treatment for moderate-to-severe glabellar lines across three individual trials – Cox SE., et al.	Abstract #2460
DYSPORT	Subject satisfaction with two treatments a year (every six months) of abobotulinumtoxinA is high among both previously treated and toxin-naive cohorts – Cohen J., et al.	Abstract #2527
DYSPORT	Millennial subject satisfaction with two treatments of abobotulinumtoxinA a year – Cohen J., et al.	Abstract #2529
RESTYLANE	A randomized, controlled, evaluator-blinded study of HA-RD for chin augmentation and correction of chin retrusion – Moradi A., et al.	Abstract #2323
RESTYLANE	A randomized, evaluator-blinded, comparator-controlled study to evaluate HA-RV for cheek augmentation and correction of midface contour deficiencies – Moradi A., et al.	Abstract #2339

For more information, the AMWC 2021 program is available here: https://www.euromedicom.com/amwc-2021/en/program/schedule.html .

^* In September 2021, BeNeLux, France, Germany, the Nordics, Portugal, Spain, and Switzerland launched RESTYLANE EYELIGHT

**DYSPORT is marketed as AZZALURE^® in the EU for the treatment of glabellar lines

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 SCULPTRA
SCULPTRA works to stimulate the skin’s own collagen production⁵ 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.⁶ SCULPTRA is also suitable for large volume corrections of the signs of facial fat loss (lipoatrophy).⁶

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

About ALLUZIENCE
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.² Dosing and treatment intervals depend on assessment of the individual patient’s response.² The treatment interval should be no more frequent than every three months.² For more information, please see the ALLUZIENCE Summary of Product Characteristics.

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 and Hungary).

About Galderma’s collaboration with Ipsen
DYSPORT (abobotulinumtoxinA) is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age.⁸ DYSPORT is also marketed as AZZALURE in the EU,⁸ for the treatment of glabellar lines with more than 40 million treatments in the EU and U.S. combined and with approvals in 74 countries.

DYSPORT is manufactured by Ipsen, a global specialty-driven pharmaceutical company. 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, the European Union, Australia, South Korea, Canada, Brazil, Argentina and several other countries. Ipsen continues to promote DYSPORT within certain therapeutic indications in countries around the world.

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.⁹ NASHA™ and OBT™ technologies make RESTYLANE the world’s most diverse range of fillers to deliver truly individualized results.^10,11

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

References

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¹ Ascher B, Rzany B, Kestemont P, et al. Liquid Formulation of AbobotulinumtoxinA: A 6-Month, Phase 3, Double-Blind, Randomized, Placebo Controlled Study of a Single Treatment, Ready-to Use Toxin for Moderate-to-Severe Glabellar Lines. Aesthet Surg J. 2020;40(1):93–104.
² Alluzience. Summary of Product Characteristics.
³ Data on file (MA-48305).
⁴ Verpaele A, Strand A. Restylane SubQ, a non-animal stabilized hyaluronic acid gel for soft tissue augmentation of the mid- and lower face. Aesthetic Surgery Journal . 2006 Jan;26(1):S10–7.
⁵ Bohnert K et al. Randomized, controlled, multicentered, double-blind investigation of injectable poly-L-lactic acid for improving skin quality. Plast Reconstr Surg 2019;127(4):1684–92.
⁶ Sculptra IFU. 2018.
⁷ Brown SA et al. Subject global evaluation and subject satisfaction using injectable poly-L-lactic acid versus human collagen for the correction of nasolabial fold wrinkles. Plast Reconstr Surg 2011;127(4):1684–92.
⁸ Azzalure. Summary of Product Characteristics.
⁹ Data on file (MA-39680).
¹⁰ Data on file (MA-33939).
¹¹ Öhrlund A. Poster presented at AMWC 2019.

Job code: GL-RES-2100312
Date of preparation: September 2021

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