Results From Galderma’s Phase IIIb Trials Demonstrate Rapid and Long-Lasting Effect of RelabotulinumtoxinA on Crow’s Feet and Frown Lines

Both trials met their primary endpoints, demonstrating treatment with RelabotulinumtoxinA resulted in a statistically significant improvement in frown lines and crow’s feet.[1,2]

Results reinforce the rapid onset of action of RelabotulinumtoxinA, with some patients reporting improvement as early as day one in both trials.[1,2]

Results also underscore the durability of RelabotulinumtoxinA with at least a third of patients rating their frown lines as ‘improved’ or better through to month 12 in one study.[2]

Treatment was well tolerated and all treatment-related adverse events were reported as non-serious.[1,2]

News provided by
Galderma
Nov. 30, 2023 15:36
ZUG, SWITZERLAND--(Business Wire / Korea Newswire)--Galderma announced today topline results from two phase IIIb trials investigating RelabotulinumtoxinA for the treatment of glabellar lines (GL - frown lines) and lateral canthal lines (LCL - crow’s feet). Both studies met their primary endpoints, demonstrating that RelabotulinumtoxinA, a novel liquid formulation botulinum toxin A, significantly improves both frown lines and crow’s feet, with a rapid onset of action as early as day one and long duration.[1,2]

“These results provide an additional layer of confidence in the long-lasting efficacy, speed and convenience of RelabotulinumtoxinA, which not only represents the innovation of our neuromodulator portfolio, but also demonstrates our commitment to responding to the real needs of healthcare professionals and patients.” BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA

43QM2106 is a phase IIIb, randomized, double-blind, placebo-controlled trial to assess the aesthetic improvement and onset of action of RelabotulinumtoxinA in patients with moderate to severe frown lines. The trial met its primary endpoint, with 92.9% of those treated with RelabotulinumtoxinA rating their frown lines as ‘improved’ or better on the Global Aesthetic Improvement Scale (GAIS) at month one, compared to 9.1% of those treated with placebo (P<0.001).[1]

Results reinforced the rapid onset of action and durability of RelabotulinumtoxinA, with 40% of patients rating themselves as ‘improved’ or better on the GAIS as early as day one, and more than a third (38%) of patients rating themselves as ‘improved’ or better at month 12. In addition, 68% and 43% of patients rated themselves as ‘improved’ or better at months six and nine respectively, and 40% of patients also reported at least a one grade improvement of frown line severity at month nine. RelabotulinumtoxinA was well tolerated; the majority of patients did not experience any adverse events and there were no related serious adverse events reported.[1]

43QM2107 is a phase IIIb, open-label, single-center study to assess aesthetic improvement of RelabotulinumtoxinA in patients with moderate to severe crow’s feet and frown lines. It also met its primary endpoint, with 100% of patients treated with RelabotulinumtoxinA rating their crow’s feet and frown lines as ‘improved’ or better on the GAIS at month one.[2]

RelabotulinumtoxinA demonstrated a rapid onset of action for both crow’s feet and frown lines, with the majority of patients (68% and 60% for crow’s feet and frown lines, respectively) rating themselves as ‘improved’ or better on the GAIS starting at day one. By day two, 100% of patients noted improvement for crow’s feet and 96% noted improvement for frown lines. This was reinforced by Subject Live Assessment results using a validated scale, which showed that 40% of patients on day one and 96% of patients on day four received a score of zero or one on a four-point scale for crow’s feet severity at maximum expression. For frown line severity, 32% of patients on day one and 92% of patients on day four received a score of zero or one. RelabotulinumtoxinA was well tolerated, with no adverse events reported in 92% of patients.[2]

Results from both studies are in line with those previously seen for RelabotulinumtoxinA.[3,4]

About RelabotulinumtoxinA (QM1114)
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 unique state-of-the-art process. It is designed as a liquid, avoiding the traditional requirement to reconstitute from powder and eliminating variability, errors and risks associated with reconstitution, which would be expected to improve the consistency of results. RelabotulinumtoxinA is currently being investigated globally by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market.

About Galderma
Galderma is the emerging 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 though 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] Galderma data on file: initial results of the phase IIIb 43QM2106 trial
[2] Galderma data on file: initial results of the phase IIIb 43QM2107 trial
[3] 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
[4] 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.

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Website: http://www.galderma.com

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Galderma
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+41 76 315 26 50
christian.marcoux@galderma.com

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Corporate Communications Director
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Jessica Cohen
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+41 21 642 76 43
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