FDA Approves IncobotulinumtoxinA for the Simultaneous Treatment of Upper Facial Lines

IncobotulinumtoxinA (Xeomin; Merz Aesthetics) received FDA approval for the simultaneous treatment of upper facial lines including forehead lines, frown lines, and crow’s feet. The decision is based on positive results from a phase 3 trial, which demonstrated optimal safety and treatment efficacy of incobotulinumtoxinA to temporarily improve the appearance of moderate to severe facial lines.

The positive results of the trial indicate the safety and efficacy of incobotulinumtoxinA to treat the appearance of moderate to severe upper facial lines. Image Credit: © Africa Studio - stock.adobe.com

Aesthetic dermatology is a relatively newer field of medicine and was in its infancy in the 1980s and 1990s. In its early days, it included lasers, minimally invasive facial surgery, and injectables like botulinum toxin (Botox; Allergan, Inc) and dermal fillers (Juvederm; Allergan, Inc). Knowledge of aesthetic dermatology and proper practices were limited, meaning clinicians lacked proper education and training for performing procedures safely and effectively. This led to the infamous “Spock brow,” which happens when botulinum toxin is injected too high in the glabella.¹

By the mid-2000s, aesthetic medicine became increasingly popular and there was increased knowledge of proper treatment protocols. Botulinum toxin and dermal fillers remain the standard of care for patients seeking to minimize the appearance of aging and facial lines. IncobotulinumtoxinA may offer patients an advanced, alternative treatment option with improved safety and efficacy.¹

IncobotulinumtoxinA, a neuromuscular blocker, has various therapeutic uses, including treating muscle spasms in the eyelid (blepharospasm), neck (cervical dystonia), and limb muscles, as well as cosmetic applications of the glabellar frown lines on the face. Compared with other toxin treatments, incobotulinumtoxinA only contains active neurotoxin and is free from complexing proteins, which some studies suggest may cause an immune response leading to decreased efficacy and treatment failure. Data from a survey indicate that just over 1 in 3 toxin users reported lessening effects from other toxin treatments.^2-4

In a phase 3 double-blind, placebo-controlled study, 730 adult participants were randomized to receive incobotulinumtoxinA or a placebo. The results showed that incobotulinumtoxinA had a significantly higher response rate compared with placebo at day 30 for all upper facial lines. All treatment-related adverse events (AEs) were mild to moderate, and data showed high patient satisfaction with continued efficacy over 14 months of continued treatment cycles. Based on the trial data, the recommended dosage is 20 units in the glabellar and horizontal frown lines, and 24 units for the crow’s feet.⁴

The positive results of the trial indicate the safety and efficacy of incobotulinumtoxinA to treat the appearance of moderate to severe upper facial lines, offering patients treatment results that rejuvenate their appearance and inspire confidence. The approval of the expanded use of incobotulinumtoxinA for simultaneous treatment of glabellar frown lines marks a significant advancement in aesthetic dermatology and pave the way for new standard in the toxin market.

"[IncobotulinumtoxinA] is the first and only FDA-approved neurotoxin for the simultaneous treatment of upper facial lines (forehead lines, frown lines and crow’s feet lines),” said Samantha Kerr, PhD, chief scientific officer of Merz Aesthetics, in a press release. “This new indication for [incobotulinumtoxinA] proves we are moving the needle within the toxin space and meeting the needs of our consumers as it comes to efficacy and results, while containing only the essential ingredients needed for treatment.”⁴

REFERENCES

1. History and politics of aesthetic/cosmetic medicine. American College of Aesthetic and Cosmetic Physicians. Accessed July 24, 2024. https://www.medicalaestheticsociety.org/history.htm

2. IncobotulinumtoxinA injection. Cleveland Clinic. Accessed July 24, 2024. https://my.clevelandclinic.org/health/drugs/20132-incobotulinumtoxina-injection

3. Imhof M, Kühne U. A Phase III Study of IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines. J Clin Aesthet Dermatol. October 2011. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3196303/

4. Merz aesthetics announces fda approval of xeomin® (incobotulinumtoxina) as the first and only u.s. neurotoxin for the simultaneous treatment of upper facial lines. Business Wire. July 23, 2024. Accessed July 24, 2024. https://www.businesswire.com/news/home/20240723538247/en