IMCAS 2023: Galderma to Share Latest Data Demonstrating High Aesthetic Improvement and Patient Satisfaction Across Its Innovative Portfolio

Galderma will share exciting results from the Sculptra® Cheek Wrinkle study showing the long-lasting effectiveness and safety of Sculptra, as well as high aesthetic improvement and patient satisfaction over two yearsi

The company will also present 10 research posters, including positive outcomes from the Alluzience® STAR study. This study shows high patient satisfaction and investigator preference for Alluzience over powder solutions and long duration of effect at six monthsii

Two symposia will build on Galderma’s Holistic Individualized Treatment (HIT™) approach through programs Kiss & Smile™ and Balanced Profile™, and on another new solution offering an innovative long-term treatment approach

Galderma will be showcasing the latest updates from across its portfolio at the International Master Course on Aging Science (IMCAS) World Congress 2023 in Paris from January 26-28, 2023. Events will include several ‘meet the expert’ sessions and interactive booth activities. In addition, Galderma will share 10 research posters and host two symposia, featuring data from its broad, highly differentiated portfolio of neuromodulators, biostimulators and fillers. Presenters and contributors will draw from the company’s research into serious skin conditions, such as rosacea and actinic keratosis.

Galderma is the only pure-play dermatology category leader, with more than 40 years of heritage in dermatology. Its significant presence at IMCAS underscores its commitment to delivering science, innovation and a premium experience for physicians, consumers and patients throughout the treatment journey. Galderma is a leader in bringing cutting-edge products to market and in providing the scientific community with individualized treatment approaches, training and business support.

“The strength and span of our presence at IMCAS 2023 reinforce our enduring commitment to providing physicians, consumers and patients with truly innovative and individualized solutions. We look forward to connecting with the dermatology community at the congress. We will not only share our latest data but also support physicians as they take the best approach in education, assessment and technique.” said BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D, GALDERMA.

Presenting the latest in clinical findings and educational efforts

Galderma will be sharing important data at IMCAS on Sculptra® (injectable poly-L-lactic acid, PLLA-SCA). This is the first and only U.S. Food and Drug Administration (FDA)-approved PLLA facial injectable treatment that helps stimulate the skin’s type I collagen production.iii,iv Sculptra helps restore fullness and firmness to areas of the face that become loose or saggy. The results of the innovative Sculptra Cheek Wrinkle study, which were measured using state-of-the-art technology, show the early onset, long-lasting effectiveness and safety of the treatment for cheek wrinkle correction over 24 months. These findings were complemented by high aesthetic improvement, high subject satisfaction with cheek appearance, and improvement in skin quality parameters including radiance and skin firmness (tightness) after treatment.i

Additional exciting data will be presented for Galderma’s neuromodulators, in particular for Alluzience® (abobotulinumtoxinA solution), including the latest data from Alluzience’s first phase IV study, STAR. Approved in Europe in June 2021, Alluzience is Europe’s first ready-to-use liquid neuromodulator for the treatment of moderate to severe glabellar lines (frown lines). Results from the unique STAR study show high patient satisfaction, with most investigators preferring Alluzience to powder solutions. Both investigators and patients also reported long-duration aesthetic improvement following a six-month follow-up period.ii

Galderma’s symposia at IMCAS highlight its dedication to providing not only innovative products but also cutting-edge approaches to support physician assessment and technique.

The first symposium builds on Galderma’s Holistic Individualized Treatment (HIT™) series with a focus on two new programs: HIT Kiss & Smile™ and Balanced Profile™. HIT is a patient-centric, science-based, individualized treatment approach that enables injectors to leverage their expertise with the renowned Galderma portfolio and optimize aesthetic outcomes while prioritizing patient satisfaction. The event is taking place in the Amphitheatre Bleu, Level 2 on Friday, January 27, from 8:30 to 10:00 AM CET.

The second symposium, Our Aesthetic Lives: A long-term journey into aesthetic treatments, will deep-dive into the aesthetic lives of patients and the medical professionals who treat them as they shape the future of this field. It will take place in the Amphitheatre Bleu, Level 2 on Friday, January 27, from 4:00 to 6:00 PM CET.

Showcasing cutting-edge research with 10 research posters

Neuromodulators

Galderma will be sharing several updates on its neuromodulators, Alluzience and Azzalure® (abobotulinumtoxinA), including:

· Ready-to-use abobotulinumtoxinA solution versus powder onabotulinumtoxinA for treating glabellar lines: Subjects’ and Investigators’ experiences ii
· Subject and physician satisfaction with abobotulinumtoxinA for glabellar line treatment in a real-world study in Chinese subjectsv
· How glabellar line severity at baseline can affect efficacy in neurotoxin trialsvi

Biostimulators

Posters on Sculptra, the first and only U.S. FDA-approved PLLA facial injectable treatment, include:

· Effectiveness and safety of cheek wrinkle correction using a biostimulatory poly-L-lactic acid injectable implant - clinical study data up to 24 months i
· Product manufacturing process for poly-L-lactic acid (PLLA-SCA)vii
· Skin movement and volume changes with poly-L-lactic acid (PLLA-SCA) injectable implant: a subgroup analysis of the cheek wrinkle trialviii

Fillers

Galderma will also be sharing the latest data on its portfolio of fillers, including Restylane® Defyne for chin. Restylane Defyne has demonstrated results across a wide range of participants, including participants with all skin types, males, and those over the age of 52.ix Posters include:

· Improvement of chin retrusion in Chinese subjects using a hyaluronic acid filler: a randomized, controlled, evaluator-blinded studyx
· Differentiation of NASHATM and OBT TM hyaluronic acid gels according to firmness and flexibility and associated clinical significancexi

Actinic keratosis and rosacea

For decades, Galderma has been researching these serious and often severe skin conditions that affect a significant cross-section of society, reflecting its expertise and demonstrating its commitment to advancing dermatology for every skin story. Posters include:

· Cosmetic outcomes in patient-centered management of AK - Personalizing Actinic Keratosis Treatment (PAKT) expert consensusxii
· A customized skin care routine benefits patients with severe rosacea under combination therapy with ivermectin 1% cream and doxycycline 40-mg or ivermectin and placeboxiii

About Alluzience®

Alluzience (abobotulinumtoxinA solution) is the first ready-to-use BoNT-A liquid neuromodulator formulation to be introduced in Europe. Alluzience is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines seen at maximum frown in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.xiv It should only be administered by a physician with appropriate qualifications and expertise in this treatment using the required equipment.xiv Dosing and treatment intervals depend on assessment of the individual patient’s response.xiv The treatment interval should be no more frequent than every three months.xiv For more information, please see the Summary of Product Characteristics.xiv

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 Azzalure® / Dysport®

Dysport (abobotulinumtoxinA) is a prescription injection indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients less than 65 years of age, the treatment of adults with cervical dystonia, the treatment of upper limb spasticity in adults, and the treatment of lower limb spasticity in pediatric patients two years of age and older.xv Dysport is also marketed as Azzalure in the European Union 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 more than 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 26 years of achievement and over 55 million treatments worldwide. NASHA™ and OBT™ technologies make RESTYLANE the world’s most diverse range of fillers to deliver truly individualized results.xvi,xvii

The RESTYLANE portfolio of products includes RESTYLANE, RESTYLANE® LYFTTM, RESTYLANE® KYSSETM, RESTYLANE® VOLYMETM, RESTYLANE® DEFYNETM, RESTYLANE® REFYNETM, RESTYLANE® EYELIGHTTM and RESTYLANE® SKINBOOSTERS VITALTM.

About Sculptra®

SCULPTRA is the first and original injectable collagen stimulator containing microparticles of unique poly-L-lactic acid (PLLA-SCA) which gradually revitalizes the skin’s structural foundation, providing long-term results for more than two years.xviii SCULPTRA was first approved in 1999 in Europe, and it is currently available in more than 40 countries globally.

SCULPTRA works to stimulate the skin’s own collagen productionxix to provide firm and radiant skin. It 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.xx

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 span the full spectrum of the fast-growing dermatology market through 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. Galderma’s portfolio of flagship brands includes Restylane, Dysport, Azzalure, Alluzience and Sculptra in Injectable Aesthetics; Soolantra®, Epiduo®, Differin®, Aklief®, Epsolay®, Twyneo®, Oracea®, Metvix®, Benzac® and Loceryl® in Therapeutic Dermatology; and Cetaphil® and Alastin® in Dermo-cosmetics. For more information, visit www.galderma.com.

References

i Fabi S. Poster presented at IMCAS 2023.
ii Arne Gerber P. Poster presented at IMCAS 2023.
iii Sculptra injectable poly-L-lactic acid. Instructions for Use. Galderma Laboratories. 2023.
iv Stein P. et al. J Dermatol Sci. 2015;78:26-33.
v Song W. Poster presented at IMCAS 2023.
vi Kaufman-Janette J. Poster presented at IMCAS 2023.
vii Morgan P. Poster presented at IMCAS 2023.
viii Fabi S. Poster presented at IMCAS 2023.
ix Data on file. 43USCH1702 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2020.
x Xie Y. Poster presented at IMCAS 2023.
xi Öhrlund A. Poster presented at IMCAS 2023.
xii Haedersdal M. Poster presented at IMCAS 2023.
xiii Schaller M. Poster presented at IMCAS 2023.
xiv Alluzience Summary of Product Characteristics, 2022.
xv Dysport Summary of Product Characteristics, 2022
xvi Data on file (MA-33939).
xvii Öhrlund A. Poster presented at AMWC 2019.
xviii Brown SA et al. Plast Reconstr Surg 2011;127(4):1684-92.
xix Bohnert K et al. Plast Reconstr Surg 2019;127(4):1684-92.
xx Sculptra IFU. 2018.