Galderma to Present Extensive New Clinical Data Across Its Portfolio of Neuromodulators, Fillers and Biostimulators at the IMCAS World Congress 2022
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.
“At Galderma, we are committed to advancing dermatology for every skin story. The extensive series of oral and poster presentations with new data from across our portfolio demonstrates our drive for innovation across the industry. We will also be hosting two symposia with leading physicians, reinforcing our partnership with the aesthetics community as we present work completed with them to deliver holistic individualized treatments (HITs) for patients and the science and clinical experience behind our latest innovation Alluzience, the first ready-to-use neuromodulator”
Flemming Ørnskov, M.D., MPH
Chief Executive Officer
Latest efficacy, safety & satisfaction data for neuromodulator portfolio
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:
Ready-to-use liquid abobotulinumtoxinA: An overview of available phase III clinical data for moderate-to-severe glabellar line treatment
Benjamin Ascher, et al.
Ready-to-use liquid abobotulinumtoxinA for moderate-to-severe glabellar lines: Pooling of two double-blind, randomized, controlled phase III studies
Inna Prygova, et al.
Liquid abobotulinumtoxinA for glabellar line treatment: Post hoc analysis of duration of effect and subject satisfaction phase III study data
Berthold Rzany, et al.
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:
Assessment of subject satisfaction after glabellar line treatment with escalating doses of abobotulinumtoxinA in a randomized, double-blind study
Steven Dayan, et al..
Subject satisfaction and duration of effect of on-label 50U abobotulinumtoxinA treatment of glabellar lines - results from three individual trials
Steven Dayan, et al.
Subject satisfaction with twice-yearly treatment of glabellar lines with abobotulinumtoxinA in millennials
Inna Prygova, et al.
*Approved for therapeutic use in December 1990 and aesthetic use in April 2009
New data for Restylane range of hyaluronic acid fillers
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:
Effectiveness of cheek treatment after providing a treatment guide to help choose between hyaluronic acid filler HA-VOL or HA-LYF: the CHEEKY study
Andreas Nikolis, et al.
Water uptake of hyaluronic acid fillers.
96 Week Data for Collagen Biostimulator
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:
Extension study on safety and effectiveness of PLLA for correction of nasolabial folds after changes in reconstitution and injection procedures
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.
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).
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® LYFTTM, RESTYLANE® KYSSETM, RESTYLANE® VOLYMETM, RESTYLANE® DEFYNETM, RESTYLANE® REFYNETM, RESTYLANE® EYELIGHTTM and RESTYLANE® SKINBOOSTERS VITALTM.
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.
- Ascher B. Poster #113846 to be presented at IMCAS 2022.
- Picaut, P. Oral Presentation #114879 to be presented at IMCAS 2022.
- Rzany B. Oral Presentation #114895 to be presented at IMCAS 2022.
- Kane AC et al. Plast Reconstr Surg 2009;124:1619–29.
- Dysport Summary of Product Characteristics, Galderma, July 2018.
- Brandt F et al. Dermatol Surg 2009;35:1893–1901.
- Moy RM et al. Arch Facial Plast Surg 2009;11(2):77–83.
- Rubin MG et al. J Drugs Dermatol 2009;8(5):439–444.
- Schlessinger J et al. Dermatol Surg 2014;40(2):176–183.
- Maas C et al. Aesthet Surg J 2012;32(1S):8S–29S.
- Cohen JL and Scuderi N. Aesthet Surg J 2017;37(S1):S33–S44.
- Hexsel D et al. Dermatol Surg 2018;44(12):1555-1564.
- Rubin M et al. Aesthet Surg J 2009;29:S50–S56.
- Cohen JL et al. Aesthet Surg J 2009;29(Suppl 1):S43–S49.
- Dayan S et al.Poster #114887 to be presented at IMCAS 2022.
- Dayan S et al.Poster #114885 to be presented at IMCAS 2022.
- Prygova I et al. Poster #114945 to be presented at IMCAS 2022
- Nikolis A et al. Oral Presentation #114864 to be presented at IMCAS 2022.
- LaTowsky B et al. Oral Presentation #114971 to be presented at IMCAS 2022.
- Summary of Product Characteristics, 10 June 2021.
- Data on file (MA-33939).
- Öhrlund A. Poster presented at AMWC 2019.
- 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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
For further information:
Christian Marcoux, M.Sc.
Chief Communications Officer
+41 76 315 26 50
Global Franchise Communications
+41 76 261 64 41
Global Head of Investor Relations
+1 914 497 9073
Corporate Communications Director
+41 79 529 59 85
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Teva Announces Promising Interim Results From Its Study PEARL, About the Impact of AJOVY ® (fremanezumab)24.6.2022 18:54:00 CEST | Press release
Teva Pharmaceuticals Europe B.V. today announces promising interim results from its Pan-European Real World study (PEARL), presented for the first time at the European Academy of Neurology (EAN) Congress in Vienna, Austria. The two-year Pan-European Real World (PEARL) prospective, observational study of AJOVY® (fremanezumab), looks at its effectiveness in patients with chronic migraine or episodic migraine, and is an ongoing study sponsored by Teva Pharmaceuticals Europe BV.1 These findings further offer insight into the treatment of migraine in real-world clinical practice. The interim findings were presented by Faisal Mohammad Amin, Associate Professor of Neurology at the University of Copenhagen, Denmark. Out of the total planned 1100 patients in PEARL, 389 patients are included in the interim analysis presented. These findings show that 54.7% of patients in the study had their monthly-migraine-days reduced by 50% or more, over the six-month period from the start of treatment. Addit
Brigade-M3 European Acquisition Corp. 2021 Annual Report24.6.2022 16:59:00 CEST | Press release
Brigade-M3 European Acquisition Corp. (the “Company”), a special purpose acquisition company that was incorporated on 21 April 2021 under the laws of the Cayman Islands as an exempted company with limited liability and is listed on Euronext Amsterdam, today published its annual report for the period 21 April 2021 to 31 December 2021. The full report can be downloaded from the Company’s website via the following link: https://www.brigadem3eac.com/documents IMPORTANT INFORMATION This press release contains information that qualifies as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. DISCLAIMER This announcement is not for distribution or release, directly or indirectly, and should not be distributed in or sent into, the United States, Australia, Canada, Japan, the Cayman Islands or South Africa or any other jurisdiction in which such distribution or release would be unlawful or would require registration or other measures. This announcement does n
PUMA Kicks Off Its Largest Web3 Collaboration To Date, with 10KTF Shop24.6.2022 16:41:00 CEST | Press release
PUMA has entered New Tokyo, the virtual city 10KTF calls home. The shop is known for its streetwear offerings and is owned by Wagmi-san, a digital artisan whose collections and NFT community recently welcomed the global sports brand. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220624005314/en/ PUMA Kicks Off Its Largest Web3 Collaboration To Date, with 10KTF Shop PUMA has entered New Tokyo, the virtual city 10KTF calls home. The shop is known for its streetwear offerings and is owned by Wagmi-san, a digital artisan whose collections and NFT community recently welcomed the global sports brand. (Photo: Business Wire) News of the partnership was shared at an event hosted by 10KTF last night in New York. Their event was one of many hosted during the week of NFT.NYC, a conference attended by crypto industry professionals, traders, and other web3 enthusiasts. The official announcement confirms weeks of speculation after PUMA tw
Suzano outlines ESG milestone achievements and commitments at second annual ESG call24.6.2022 16:14:00 CEST | Press release
Suzano, the world’s largest hardwood pulp producer, today held its second annual ESG Call centered around its ambition to be a ‘regenerative company for a regenerative society’. Today’s ESG Call spotlighted measurable progress and ambitions across three core areas of action: climate change, biodiversity and social development. On Climate Change, the ACT initiative of the French Government and CDP scored Suzano ahead of its pulp and paper industry peers in virtually every metric. In 2021, Suzano brought forward its target for removing 40 million tons of carbon dioxide from the atmosphere from 2030 to 2025 which is being achieved through improvements to its industrial processes, such as systematically replacing the use of fossil fuels at its industrial plants with biomass, and through conversion of degraded land. As part of the company’s social commitments, Suzano launched a target in 2020 to lift 200,000 people out of poverty. This is more than pertinent, given that in Brazil, 10% of th
Kyowa Kirin Receives Positive CHMP Opinion for Use of CRYSVITA ® ▼ (burosumab) for the Treatment of Tumour-Induced Osteomalacia (TIO)24.6.2022 15:38:00 CEST | Press release
Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that CRYSVITA® (burosumab) be approved for the treatment of FGF23-related hypophosphataemia in Tumour-Induced Osteomalacia (TIO) associated with phosphaturic mesenchymal tumours (PMTs) that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.1 CRYSVITA is also already licensed for use in the rare disease X-Linked Hypophosphataemia (XLH), for children and adolescents between 1 and 17 years of age with radiographic evidence of bone disease, and in adults.2 Also known as oncogenic osteomalacia, TIO is an acquired disorder caused by typically small, slow-growing, benign PMTs.3,4 It is a rare condition with less than 1000 cases reported in the medical literature,4 which mainly affects adults and with a mean onset age of 40 – 45 years.3,5 TIO is associated with p
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom