Galderma Announces Positive Results in Two Phase III Studies for a Novel Liquid Formulation botulinumtoxinA (RelabotulinumtoxinA) for the Treatment of Glabellar Lines (frown) and Lateral Canthal Lines (crow’s Feet)

• Both studies met their primary endpoints with significantly higher response than placebo after one month for both frown lines and crow’s feet

• Results showed rapid onset of action with median response within two days (39% saw results on Day 1 for frown lines and 34% on Day 1 for crow’s feet)

• Results also demonstrated long duration of action up to six months and high participant satisfaction

• Treatment was well tolerated with all treatment-related adverse events mild-to-moderate and non-serious

(BUSINESS WIRE) -- Galderma announced today at the Vegas Cosmetic Surgery & Aesthetic Dermatology meeting, topline results from two phase III clinical studies (NCT04249583, NCT04249687) demonstrating that RelabotulinumtoxinA, a novel liquid formulation botulinum toxin A, improves both glabellar and lateral canthal lines with a rapid onset of action and a long duration up to six months.^1,2

Developed by Galderma, RelabotulinumtoxinA is a highly-active, innovative, complex-free, and ready-to-use liquid botulinum toxin A with a proprietary strain and manufactured using a state-of-the-art, unique process.^1,3 RelabotulinumtoxinA is designed as a liquid, avoiding the traditional requirement to reconstitute from powder, eliminating variability, errors and risks associated with reconstitution, which would be expected to improve the consistency of results. The READY (RElabotulinumtoxin Aesthetic Development StudY) phase III clinical program is composed of four phase III clinical trials which enrolled more than 1,900 participants.

"We developed this innovative neuromodulator to respond directly to the needs of healthcare professionals and the expectations of patients who are looking for a safe, effective, long-lasting treatment that offers consistency in results for frown lines and crow’s feet, which can have a significant impact on patients’ self-esteem and well-being.  We are looking forward to submitting the data to U.S. and global authorities as part of the next step in bringing this potential, new treatment to patients.”

Baldo Scassellati Sforzolini, M.D.
Global Head of Research & Development
Galderma

Both studies met their primary endpoint, demonstrating a significant ≥2-grade composite improvement (as assessed by both subject and investigator) in glabellar line severity and lateral canthal line severity vs. placebo at Month 1, with rapid onset of action and up to six-month duration of action.

The first clinical study, READY-1, was a multicenter, randomized, double-blind, placebo-controlled, phase III trial of RelabotulinumtoxinA for the treatment of moderate-to-severe glabellar lines (frown lines) in 300 participants followed for six months.¹ Results from READY-1 showed that RelabotulinumtoxinA significantly reduced glabellar line severity and was well tolerated.¹

READY-1 met its primary endpoint for participants with moderate-to-severe glabellar lines – the response to RelabotulinumtoxinA was significantly higher than placebo after one month (82.9% vs. 0%; P<0.001).¹

In the trial, RelabotulinumtoxinA had a rapid onset of effect (median 2 days, 39% of participants reported an effect on Day 1) and the effects were long-lasting, persisting for up to six months. The median time to return to baseline severity was >24 weeks (end of study).¹

Participant satisfaction with treatment was high for RelabotulinumtoxinA vs. placebo. At Month 1, 97% of participants were satisfied with the outcome of treatment and 86% remained satisfied at Month 6.¹ Treated participants were also highly satisfied with how natural they looked (97% at Month 1, 88% at Month 6).¹

The second study, READY-2, was a multicenter randomized,double-blind, placebo-controlled, phase III trial of RelabotulinumtoxinA for the treatment of moderate-to-severe lateral canthal lines (crow’s feet).² Results from the six-month study, involving 303 participants, showed that treatment with RelabotulinumtoxinA improved lateral canthal lines, with high participant satisfaction and a rapid onset of effect.²

READY-2 met its primary endpoint with the response among those participants receiving treatment significantly higher than placebo (51.8% vs. 1.4%, P<0.001).²

The onset of effect was rapid (median 2 days, 34% of participants reported onset of effect by Day 1) and the effect was long-lasting, up to six months. The median time to return to baseline severity was 173 days (24.7 weeks).²

Safety and tolerability profile
In both studies, RelabotulinumtoxinA was well tolerated.^1,2 All treatment-related adverse events were mild-to-moderate, non-serious and transient.^1,2

In READY-1, 3.6% of treated participants (0%, placebo) experienced a treatment-related adverse event; the most common was headache.¹ In READY-2, treatment-related adverse events occurred in 6.1% of treated participants (5.5%, placebo) and the most common was injection-site bruising.²

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 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

References:

1. 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

2. 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.

3. 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.

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