AAD 2025: Galderma to Pres

AAD 2025: Galderma to Present Extensive Updates From Across Its Dermatology Portfolio, Demonstrating Its Category Leadership and Strong Momentum

• New data on Nemluvio^®      (nemolizumab), including an oral e-poster presentation characterizing the      impact of Nemluvio in different pruriginous lesion types in prurigo      nodularis from the phase III OLYMPIA program, and post-hoc analyses      exploring the continuous response of Nemluvio up to 56 weeks in atopic      dermatitis patients from the ARCADIA 1&2 trials and long-term      extension study who had partial or no disease response at week 16

• The latest data from the      phase III READY-4 and phase IIIb RELAX studies of ready-to-use liquid      neuromodulator Relfydess^® (RelabotulinumtoxinA), which has      previously demonstrated a six-month clinical effect and rapid onset from      day one for frown lines and crow’s feet, in the phase III READY clinical      trial program^1-3

• Updates on Restylane^® and      Sculptra^®, including data from a study exploring the benefits      of Restylane Lyft™ or Contour™ with Sculptra in patients with      medication-driven weight loss with associated facial volume loss, as well      as new data from Galderma’s acne and sensitive skin product portfolio

• With 22 presentations in      total, the extent and range of data to be shared underscore the pace of      Galderma’s growth journey, which AAD attendees can further explore at      booth #2021

ZUG, Switzerland -- (BUSINESS WIRE) --

Galderma will present updates from across its broad dermatology portfolio at the 2025 American Academy of Dermatology (AAD) Annual Meeting, taking place from March 7-11, 2025 in Orlando, Florida. The company will present 22 e-posters – including two oral presentations – with updates on a number of its innovative products, including Nemluvio, Sculptra, Restylane and Relfydess. These presentations combined reinforce the strength of Galderma’s growth journey, its status as the pure-play category leader in dermatology, and its innovative pipeline.

“We’re bringing impactful new science to this year’s AAD meeting, with new data on Nemluvio – our treatment for prurigo nodularis and atopic dermatitis – and the latest from our Dermatological Skincare and Injectable Aesthetics portfolios. This demonstrates how Galderma continues to move from strength to strength, as a category leader in dermatology with a strong portfolio spanning the full spectrum of this fast-growing market.”

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.
GLOBAL HEAD OF R&D
GALDERMA

New data on atopic dermatitis and prurigo nodularis

New data on Nemluvio reinforce its benefit for a broad range of patients with prurigo nodularis and atopic dermatitis.

An oral presentation will report new data on the efficacy of Nemluvio treatment up to Week 16 across different pruriginous lesion types in patients with prurigo nodularis from the phase III OLYMPIA program. This will be presented on Friday, March 7.

The company will also share data demonstrating the continuous response with Nemluvio up to 56 weeks in patients with moderate-to-severe atopic dermatitis who had a partial or no response to treatment at Week 16 in the ARCADIA 1&2 trials and long-term extension study.

Alongside this, real-world evidence on atopic dermatitis will be shared, including an oral e-poster presentation with findings from a retrospective analysis of access disparities for atopic dermatitis patients across ethnic groups using the U.S. Medicaid database (Sunday, March 9), and data exploring the association between itch severity and initiation of biologic therapy.

On Sunday, March 9, Galderma will also host an Industry Session Theatre titled ‘Targeting the IL-31 Neuroimmune Pathway: Transforming Itch and Inflammation Outcomes’. Presented by Dr. Jonathan Silverberg and Dr. Sarina Elmariah, this patient and expert panel discussion will delve into the crucial need to address neuroimmune interactions with atopic dermatitis and prurigo nodularis, the impact of IL-31, and how a targeted treatment improves real patient outcomes.

Aesthetic advancements across Galderma’s portfolio

Galderma will also present the latest data from across its Injectable Aesthetics portfolio, including updates on Restylane, Sculptra, and Relfydess.

Interim data from a study exploring the benefits of Restylane Lyft or Contour with Sculptra in patients with medication-driven weight loss with associated facial volume loss will be shared.

Results from a comparative study evaluating the synergistic effects for midface improvement when pairing Sculptra with a skincare regimen will also be presented, as well as a comparative analysis of suggested genetic pathways affected by Sculptra vs another biostimulator, and consensus and evidence-based recommendations on the impact of minimally invasive treatments on subsequent facial surgery for additional aesthetic enhancement.

Additional data from Galderma’s Restylane portfolio includes the first ever ultrasound comparison of the tissue integration, dynamic support, and lifting capacity of Restylane Contour versus another rheologically different hyaluronic acid filler. Data from an AI-enabled Manufacturer and User Facility Device Experience database analysis of delayed complications with hyaluronic acid fillers will also reveal technology-based differences.

Finally, data from the phase III READY-4 study, designed to evaluate the safety of Relfydess for the long-term treatment of moderate-to-severe frown lines and crow’s feet, as well as from the phase IIIb RELAX study, evaluating the long-lasting efficacy and satisfaction of Relfydess in adults with moderate-to-severe frown lines over a 12-month period, will be presented. A separate subgroup analysis of pooled phase III data will explore the benefits of Relfydess treatment for frown lines and crow’s feet of different baseline severity. These presentations build on previously announced data from the READY clinical trial program, which demonstrated that up to 39% of patients see effects from day one and up to 75% of patients maintain improvements for six months for frown lines and crow’s feet when treated with Relfydess.^1-3

Updates on innovative solutions for acne and sensitive skin

Galderma will also present updates on its product portfolio for sensitive skin, including a dermal patch for acne-prone skin, a Ceramide Serum and Vitamin C Serum, and a novel cream designed to improve the appearance of aging skin.

In acne, results of a worldwide profiling survey on the association between adult acne and sensitive skin will be shared. Presentations on Galderma’s CTMP™: Cleanse, Treat, Moisturize, Protect regimen will also reveal its impact on adherence, treatment outcomes, patient satisfaction, and overall skin quality in patients with acne and sensitive skin.

More details on Galderma’s scientific presentations at AAD can be found here.

About Nemluvio (Nemolizumab)
Nemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan and Taiwan. In Japan, nemolizumab is marketed as Mitchga^® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.^4,5 Nemluvio has been approved by the European Commission for both moderate-to-severe atopic dermatitis and moderate-to-severe prurigo nodularis in the European Union (EU).⁶ It is now approved in the EU for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.⁶ The U.S. FDA has also approved Nemluvio for the treatment of adults with prurigo nodularis and patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies.⁷ Nemluvio is also under review for the treatment of both diseases by several additional regulatory authorities around the world. Further submissions to regulatory authorities in additional countries are ongoing.

About Relfydess (RelabotulinumtoxinA)
Pioneered by Galderma, Relfydess is the first and only ready-to-use liquid neuromodulator created with PEARL Technology that is designed to preserve molecule integrity.^8-10 PEARL Technology is designed to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months.^1-3,8-10 Relfydess is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.^8-10 It was entirely created and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market. RelabotulinumtoxinA is an investigational drug product in the U.S. Following the completion of the European Decentralized Procedure resulting in a positive decision for the use of Relfydess, Galderma has received national approvals in 14 European countries, as well as a marketing authorization from Australia’s Therapeutic Goods Administration and the Medicines and Healthcare products Regulatory Agency in the United Kingdom.

About Galderma
Galderma (SIX: GALD) 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, Dermatological Skincare, 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 are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References

1. Shridharani SM, et al.      Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid      Formulation Botulinum Toxin: Results From the READY-1 Double-Blind,      Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines. Aesthet      Surg J. 2024;44(12):1330-1340. doi: 10.1093/asj/sjae131

2. Ablon G, et al. Efficacy and      Safety of RelabotulinumtoxinA Liquid Botulinum Toxin in the Treatment of      Lateral Canthal Lines: Results From the Phase 3 READY-2 Study. Dermatol      Surg. 2024. doi: 10.1097/DSS.0000000000004470

3. Relfydess. EU Summary of      Product Characteristics 2024

4. Chugai Pharmaceutical Co.,      Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and      Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online.      Accessed February 2025

5. ClinicalTrials.Gov. Efficacy      & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic      Dermatitis (NCT03985943). Available online.      Accessed February 2025

6. Nemluvio. EU Summary of      Product Characteristics 2025

7. NEMLUVIO (nemolizumab-ilto)      injection 30 mg Prescribing Information. Dallas, TX: Galderma      Laboratories, L.P.; August 2024

8. Sundberg AL and Stahl U.      Relabotulinum toxin - a novel, high purity BoNT-A1 in liquid formulation.      Presented at: TOXINS 2021; Jan 16-17, 2021; virtual meeting

9. Do M, et al. Purification      process of a complex-free highly purified botulinum neurotoxin type A1      (BoNT-A1) - RelabotulinumtoxinA. Presented at: TOXINS 2022; July 27-30,      2022; New Orleans, LA

10. Persson C, et al. Patient and      Investigator Treatment Experience with Ready-to-Use AbobotulinumtoxinA      Solution Versus Powder BotulinumtoxinA for Treatment of Glabellar Lines.      Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin