LetibotulinumtoxinA (Letybo®) demonstrates significantly smaller diffusion characteristics compared to other neuromodulators

Press Release LetibotulinumtoxinA (Letybo®) demonstrates significantly smaller diffusion characteristics compared to other neuromodulators  A new study on diffusion characteristics of letibotulinumtoxinA, onabotulinumtoxinA and abobotulinumtoxinA and its impact on muscle relaxation demonstrates significantly smaller diffusion with letibotulinumtoxinA compared to other neuromodulators.1  The results, conducted under the leadership of Prof. Martina Kerscher at the University of Hamburg, Germany, showcase a more targeted diffusion with letibotulinumtoxinA and confirm Letybo® being a precise toxin.  Letybo®`s efficacy2 and precision suggest significant potential for applications where controlled toxin diffusion is needed. Leobendorf, 18th June 2025: Croma Pharma would like to congratulate the team of Prof. Martina Kerscher1*, based at the University of Hamburg, Germany, on latest study results which included examination of letibotulinumtoxinA (Leti-BoNTA) published in the peer- reviewed international journal Dermatology & Therapy. Injections with Botulinumtoxin typeA (BoNTA) are the most common non-surgical aesthetic procedures, but carry risks, like unintended muscle diffusion. Understanding the formulation behaviour therefore is key to optimizing safety and efficacy when treating patients. The study team compared the diffusion characteristics from Leti-BoNTA to Ona- BoNTA and Abo-BoNTA and its impact on muscle relaxation of the frontalis muscle. The study was conducted as a double-blind, randomized trial in 30 healthy adults that received Leti-BoNTA on one forehead side, and either Ona-BoNTA or Abo- BoNTA on the other. The area of anhidrosis was measured via Minor’s starch test over 6 months, and wrinkle severity was assessed through photographic evaluation using validated FHL scales. The results show that Leti-BoNTA had a significantly smaller maximal anhidrotic area than Ona-BoNTA (-15.1 ± 5.5 cm², p < 0.001) and Abo-BoNTA (-25.2 ± 14.5 cm², p < 0.001). Dr. Daniela Rudowitz, BCMAS, Global Medical Director at Croma Pharma GmbH, commenting the study results, emphasized: “These results provide scientific evidence that letibotulinumtoxinA can be considered a very precise toxin. Safety data from phase 3 clinical trials as well as feedback from injectors had already indicated a targeted area of effect for this neuromodulator, and we are delighted that hypotheses are now confirmed through robust study data.” LetibotulinumtoxinA is the number one neurotoxin in South Korea, one of the world’s leading aesthetic markets3. Croma holds the licensing rights for letibotulinumtoxinA from Hugel Inc. for Europe. With the launch of Letybo ® in Europe in 2022 Croma has significantly enhanced its broad, minimally invasive aesthetics range of hyaluronic acid (HA) fillers, PDO threads, biostimulators and its complementary skincare. About Croma Croma-Pharma® is a global player in the minimally invasive aesthetics market and a leading European manufacturer of premium quality hyaluronic acid syringes. The company offers a comprehensive and innovative aesthetics portfolio including botulinum toxin, fillers, lifting threads and biostimulators complemented by its own skincare brand. Founded in 1976 by the pharmacist couple Prinz, Croma-Pharma ® GmbH is a family company headquartered in Austria where it also operates its manufacturing plant. With 550 employees, 13 subsidiaries in Europe and Brazil, two joint ventures and 60 exclusive export partners, it distributes its products in 80 markets globally, including the US/Canada, China and Australia/New Zealand. It also operates as a contract manufacturer in orthopaedics and ophthalmology. For more information, please visit cromapharma.com. Press contact CROMA-PHARMA GmbH Valentin Gruber Director Global Marketing & Customer Experience Cromazeile 2 A-2100 Leobendorf Phone: +43 676 84 6868 677 E-mail: [email protected] Web: www.croma.at Affiliations: 1*Cosmetic Science, Institute of Biochemistry and Molecular Biology, University of Hamburg, Germany References: 1 M. Bennek, D. Rudowitz, M. Kerscher, Diffusion characteristics of LetibotulinumtoxinA, OnabotulinumtoxinA and AbobotulinumtoxinA and its impact on muscle relaxation: A Randomized Split-Face Clinical Trial, Dermatology & Therapy, 2025 2 Letybo® SMPC 3 Data on file Letybo 50 units powder for solution for injection. Abbreviated Prescribing Information Please refer to the Summary of Product Characteristics (SmPC) before prescribing. Presentation: One vial contains 50 units botulinum toxin type A produced by Clostridium botulinum. After reconstitution each 0.1 mL of the solution contains 4 units. Indication: For the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows in adults <75 years old seen at maximum frown (glabellar lines), when the severity of the facial lines has an important psychological impact. Dosage and administration: Should only be administered by physicians with expertise in this treatment. Posology: The recommended dose is a total of 20 units divided into five injections of 4 units (0.1 mL) each: 2 injections in each corrugator supercilii muscle and 1 injection in the procerus muscle. Botulinum toxin units are not interchangeable from one product to another. Doses recommended are different from other botulinum toxin preparations. Treatment interval should not be more frequent than every three months. In the absence of any undesirable effects secondary to the previous treatment session, a further treatment session with at least a three-month interval between the treatment sessions is possible. The efficacy and safety of repeat injections beyond 12 months has not been evaluated. Special populations: No specific dose adjustment is required for use in the elderly older than 65 years of age . Letybo is contraindicated in patients 75 years or older. There is no relevant use in the paediatric population. Method of administration: Intramuscular use. Care should be taken to ensure that Letybo is not injected into a blood vessel. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis). Presence of acute infection or inflammation at the proposed injection sites. Patients with bleeding disorders. Warnings and Precautions: Injection into vulnerable anatomic structures must be avoided. Avoid use when the muscle shows excessive weakness or atrophy. Risk of eyelid ptosis following treatment. Procedure-related events: Needle-related pain and/or anxiety have resulted in vasovagal responses, including transient symptomatic hypotension and syncope after treatment with other botulinum toxins. Pre-existing neuromuscular disorders: Patients with unrecognised neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical doses of botulinum toxin type A. Hypersensitivity reactions: An anaphylactic reaction may occur after injection of botulinum toxin. Epinephrine (adrenaline) or any other anti-anaphylactic measures should therefore be available. Local or distant spread of toxin effects: Adverse reactions possibly related to the spread of toxin distant from the site of administration have been reported. Patients may experience exaggerated muscle weakness. Swallowing and breathing difficulties are serious and can result in death. Use not recommended in patients with a history of dysphagia and aspiration. Patients should be advised to seek immediate medical care if swallowing, speech or respiratory disorders arise. Pregnancy & Lactation: Not recommended during pregnancy or lactation and in women of childbearing potential not using contraception. Undesirable effects: Most common effects are headache and injection site reaction. Very rarely aspirational pneumonia. For full list of side effects, consult SmPC. Legal Category: POM. MA Holder: Croma-Pharma GmbH, Industriezeile 6, 2100 Leobendorf, Austria. Date of preparation: June 2023. PLEASE CHECK YOUR LOCAL APPROVAL STATUS. PRDIFF0625GMC The full study report can be accessed here: M. Bennek, D. Rudowitz, M. Kerscher, Diffusion characteristics of LetibotulinumtoxinA, OnabotulinumtoxinA and AbobotulinumtoxinA and its impact on muscle relaxation: A Randomized Split-Face Clinical Trial, Dermatology & Therapy, 2025

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