New data from Galderma's aesthetics portfolio to be presented at 2022 ASDS Annual Meeting

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Oct 07, 2022, 14:00 ET

New pivotal study data demonstrating the safety and effectiveness of Sculptra, the only U.S. FDA-approved PLLA biostimulator, in the correction of cheek wrinkles to be presented. This new data will support an expanded indication for Sculptra in the U.S.
Several presentations from two Phase 3 studies (READY-1 and READY-2), demonstrating high patient satisfaction for Galderma's investigational ready-to-use liquid botulinum toxin, relabotulinumtoxinA. Results showed rapid onset of action, with 39% patients seeing results on Day 1 for frown lines and 34% on Day 1 for crow's feet and demonstrated long duration of action through six months

DALLAS, Oct. 7, 2022 /PRNewswire/ -- Galderma announced today that it will be showcasing its latest scientific updates at the 2022 American Society for Dermatologic Surgery (ASDS) Annual Meeting taking place October 6-10, 2022, in Aurora, Colorado.

Galderma has decades of aesthetics innovation with a highly diverse portfolio of world recognized injectable technologies across hyaluronic acid (HA) fillers, botulinum neuromodulators and collagen biostimulators. Continuous innovation is a cornerstone of its commitment to advancing dermatology, and the presentation of new data for an investigational indication for Sculptra, its established collagen biostimulator, and for their unique, investigational, proprietary strain neuromodulator, relabotulinumtoxinA, is testament to its best-in-class innovation capabilities as one of the few companies capable of inventing, developing and bringing to market truly innovative dermatological solutions for physicians and patients.

"The aesthetics industry is experiencing rapid expansion and our new innovation is aimed at meeting the demand we hear from our customers for safe and effective treatments with results they can trust. Through continued innovation across the portfolio, Galderma is driving the future of aesthetics forward and addressing the unmet needs of both healthcare professionals and the patients they treat.

BILL ANDRIOPOULOS, Ph.D.
VICE PRESIDENT, MEDICAL AFFAIRS, GALDERMA U.S.

Details about Galderma's video presentations are as follows:

Sculptra
A randomized, controlled study to assess effectiveness and safety of correction of cheek wrinkles using a biostimulatory poly-L-lactic acid injectable implant
Presented by Tiffani Hamilton, MD
Video presentation

For the first time, data will be presented from a Phase 3 randomized, controlled pivotal study evaluating the effectiveness and safety of its injectable biostimulator poly-L lactic acid (PLLA), Sculptra, for the correction of cheek wrinkles versus a no-treatment control
The study showed long-lasting efficacy out to month 12, with a Galderma Cheek Wrinkle Scales (GCWS at rest) responder rate of 71.6% and improved skin radiance, tightness and jawline contour (≥ 86%)
The treatment was considered safe and well tolerated in the study, with mostly mild and transient related adverse events resolving within two weeks

RelabotulinumtoxinA
Data will be presented for the first time for the READY-1 and READY-2 Phase 3 studies of relabotulinumtoxinA for the treatment of glabellar lines (frown) and lateral canthal lines (crow's feet) demonstrating high patient satisfaction and psychological well-being, in addition to previously reported safety and efficacy.^1,2

Both studies met their primary endpoints, with significantly higher response than placebo after one month for both frown lines and crow's feet^1,2

Results showed rapid onset of action, with 39% patients seeing results on Day 1 for frown lines and 34% on Day 1 for crow's feet
Results also demonstrated long duration of action through six months
Treatment was well tolerated, with all treatment-related adverse events mild-to-moderate and non-serious

High rates of subject-reported improvement and satisfaction after glabellar line treatment with relabotulinumtoxinA, an investigational ready-to-use liquid botulinum toxin (READY-1 Phase III trial)
Presented by Lisa Donofrio, MD
Video presentation

In the READY-1 study investigating relabotulinumtoxinA for the treatment of glabellar lines, subjects reported an improvement in line severity and aesthetic appearance maintained through Month 6
Subjects also reported looking great, more natural and feeling happier on the Facial Lines Treatment Satisfaction Questionnaire (FLTSQ) through Month 6 after treatment
Additionally, subjects reported their psychological well-being (measured by the subject's FACE-Q™ psychological function scores) improved by +11.0 or higher over baseline

High subject satisfaction and natural-looking results after treatment of lateral canthal lines with relabotulinumtoxinA, an investigational liquid botulinum toxin (READY-2 Phase III trial)
Presented by Melanie Palm, MD, MBA
Video presentation

In the READY-2 study investigating relabotulinumtoxinA for the treatment of lateral canthal lines, subjects reported high satisfaction with their treatment outcome (≥ 84%), natural results (≥ 82%) and that they would recommend the treatment to others (≥ 88%) on FLTSQ through Month 6 after treatment
Natural-looking expressions were also reported, with subjects reporting looking natural when smiling (82%) and feeling good when making expressions (69%) through Month 6

For more information, the full ASDS 2022 program is available here: https://www.asds.net/medical-professionals/annual-meeting.

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. For more information: www.galderma.com/us.

About Galderma's investigational drug, a ready-to-use liquid formulation of botulinum toxin type A for the treatment of glabellar and lateral canthal lines
RelabotulinumtoxinA is a highly-active, innovative, complex-free and ready-to-use liquid botulinum toxin A with a proprietary strain, manufactured using a state-of-the-art, unique process.^1,3 Clinical data have demonstrated its safety and efficacy in the treatment of glabellar (frown) lines and lateral canthal lines (crows feet) in more than 1900 patients across four Phase 3 studies.

Media Relations
Zach Randles-Friedman
Head of U.S. Communications
[email protected]
+1 305 299 5700

References:

Shridharani, S., et al. Treatment of moderate-to-severe glabellar lines with RelabotulinumtoxinA, a new liquid botulinum toxin: Clinical efficacy and safety results from the READY-1 Phase III trial. Poster presented at Vegas Cosmetic Surgery & Aesthetic Dermatology 2022, Las Vegas, NV, June 8-11, 2022.
Ibrahim, SF, et al. Treatment of lateral canthal lines with RelabotulinumtoxinA, a new liquid botulinum toxin: Clinical efficacy and safety results from the READY-2 Phase III trial. Poster presented at Vegas Cosmetic Surgery & Aesthetic Dermatology 2022, Las Vegas, NV, June 8-11, 2022.
Liljegren Sundberg, Å and Ståhl, U. Relabotulinum toxin – a novel, high purity BoNT-A1 in liquid formulation. Poster presented at TOXINS, virtual online event, January 16-17, 2021.

SOURCE Galderma