Chicago, IL—The American Board of Cosmetic Surgery (ABCS) announced that a new wrinkle-reducing, Botox-type injectable, Letybo (letibotulinumtoxinA), has earned clearance from the U.S. Food and Drug Administration for the treatment of moderate-to-severe glabellar lines. Letybo’s approval marks the first new botulinum toxin type A product to enter the U.S. aesthetic market since 2022 and adds a sixth neuromodulator option for physicians and patients seeking non-surgical facial rejuvenation.
“FDA clearance of Letybo expands injectable neuromodulator options board certified cosmetic surgeons can offer their patients,” said Jeffrey A. Swetnam, MD, FAACS, FACS, President of the American Board of Cosmetic Surgery. “For years, U.S. patients have relied on Botox®, Dysport®, Xeomin®, Jeuveau®, and Daxxify®. Letybo brings a well-studied, globally popular formula to our market.”
Already widely used overseas since 2013, Letybo works by temporarily relaxing the small facial muscles that create “expression lines.” In FDA trials, the injectable demonstrated an onset of action comparable to Botox® Cosmetic (onabotulinumtoxinA) and a median duration of three to four months. According to trial data, the most common side effects were mild injection-site tenderness, temporary headache, and transient eyelid droop—rates consistent with other neuromodulators on the U.S. market.
“Although Letybo behaves similarly to established products, its manufacturing process, accompanying proteins, and recommended dosing units are unique,” Dr. Swetnam explained. “That means injectors must become familiar with Letybo’s reconstitution guidelines, diffusion characteristics, and dilution ratios to achieve safe, predictable results.”
Letybo’s maker, Hugel, has positioned the product as a competitively priced alternative to Botox—an especially compelling prospect for patients who require maintenance injections three to four times per year. How those savings translate for American consumers will hinge on factors such as licensing agreements and provider preferences.
Cost considerations aside, Dr. Swetnam emphasized that patients should not shop solely on price. “Neuromodulators are a prescription medication and extremely technique-sensitive,” he said. “The injector’s credentials, sterile environment, and understanding of facial balance matter far more than the logo on the vial. Board certified cosmetic surgeons have the anatomical knowledge required to minimize complications and customize the dosage for each patient.”
Because Botox and Letybo share the same core ingredient—botulinum toxin A—candidates familiar with neurotoxin treatments will find the consultation process familiar. A qualified provider reviews the patient’s health history, assesses the treatment area at rest and in motion, and discusses realistic expectations. Contraindications include pregnancy, active infection at the injection site, certain neuromuscular disorders, and known hypersensitivity to botulinum toxin products. Injectors may use Letybo for patients who are looking to try something new, who have developed antibody-related resistance to another toxin, or who simply respond better to a slightly different formulation.
The ABCS encourages consumers to perform due diligence when selecting an injector. Patients can verify a surgeon’s board certification through the ABCS website before scheduling treatment. “Credentials protect patients,” said Dr. Swetnam. “FDA approval means Letybo met federal standards for safety and effectiveness, but optimal outcomes hinge on professional training and skill.”
As clinics begin adding Letybo to their treatment offerings, the ABCS will continue to be a trusted resource for cosmetic surgeons and patients alike. “Our mission is to advance safe cosmetic surgery and aesthetic medicine,” Dr. Swetnam concluded. “Introducing a new injectable is exciting, but our commitment remains the same: evidence-based care, transparent patient education, and surgical-level standards in every treatment room.”
For more information about Letybo or to locate a board-certified cosmetic surgeon, visit the American Board of Cosmetic Surgery at https://www.americanboardcosmeticsurgery.org.
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