drugset / Press release

Further clinical data confirms the safety and efficacy of letibotulinumtoxinA

2024-03-04 · Croma-Pharma GmbH · original cromapharma.com ↗

Press Release Further clinical data confirms the safety and efficacy of letibotulinumtoxinA Leobendorf, 04 March 2024 – Croma-Pharma has announced the publication of further clinical data for their botulinum toxin Letybo® (letibotulinumtoxinA). LetibotulinumtoxinA has already shown noteworthy performance in the treatment of vertical glabellar lines.*;1 A new post-hoc analysis, published in the Aesthetic Surgery Journal, now additionally highlights the efficacy and safety of letibotulinumtoxinA in the most frequent patient group (females, 35-50 years of age).**2 • 97,7% of females aged between 35-50 presented with a glabellar line severity (GLS ) improvement of >1 at week 4, this is compared to 95,0% among the remaining female population receiving active treatment.+,2 • At week 4, 73,6% of females aged 35-50 achieved a GLS score of 0 upon maximum frowning compared to only 52,2% of the remaining female population.+,2 • Females aged 35-50 had a shorter median time to onset of GLS improvement (2.8 days) compared to the remaining female population (4.2 days).2 ‘Women between 35 and 50 years of age represent the most common group of patients in today‘s aesthetic practice. We are very happy that we can support aesthetic professionals with specific, robust and peer reviewed data to meet the needs of their most common group of patients.’, commented Dr. Daniela Rudowitz, Global Medical Director. More information can be found in the full publication: htps://academic.oup.com/asjopenforum/ar�cle/doi/10.1093/asjof/ojae010/7613319 LetibotulinumtoxinA is the number one neurotoxin in South Korea, one of the world’s leading aesthetic markets. 3 Croma holds the licensing rights for letibotulinumtoxinA in Europe and is one of only five suppliers in Europe to have botulinum toxin in its product portfolio. With the phased launches of Letybo® in Europe Croma has significantly enhanced its broad, minimally invasive aesthetics range of hyaluronic acid (HA) fillers, PDO threads, biostimulators and complementary skincare lines. The latest approval was granted for Slovenia on the 15th February 2024. 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 Michael Donhofer Director Global Marketing & Public Relation Cromazeile 2 A-2100 Leobendorf Phone: +43 676 84 68 68 823 Mail: [email protected] Web: www.croma.at * Letybo® is indicated 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. ** A positive response was determined by achieving a GLS score of 0 or 1 as assessed by both subjects and investigators along with at least a 2-point improvement in GLS score relative to baseline at week 4 after the injections. + GLS score according to Investigators assessment References: 1 Mueller DS, Prinz V, Adelglass J, Cox SE, Gold M, Kaufman-Janette J et al. Efficacy and Safety of Letibotulinum Toxin A in the Treatment of Glabellar Lines: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study. Aesthet Surg J. 2022; 42(6): 677- 88 2 Michael Gold, Susan Taylor, Daniel S Mueller, Jeffrey Adelglass, Joely Kaufman-Janette, Sue E Cox, Michael Cecerle, Konstantin Frank, Mark Nestor, Efficacy and Safety of LetibotulinumtoxinA in the Treatment of Moderate and Severe Glabellar Lines in Females 35-50 Years of Age: Post – hoc Analyses of the Phase 3 Clinical Study Data, Aesthetic Surgery Journal Open Forum, 2024;, ojae010, https://doi.org/10.1093/asjof/ojae010 3 Data on file PRBLESSLET0224GMX

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