Letybo (letibotulinumtoxinA-wlbg) / Hugel, Croma Pharma - LARVOL DELTA

Compensatory Masseteric Bulging: A Novel Observation and Its Implications for Botulinum Neurotoxin Injection Techniques. (PubMed, J Cosmet Dermatol) - "Compensatory bulging underscores the need for holistic treatment addressing the entire muscle. Layered injections, guided by ultrasound and tailored dosing, mitigate asymmetry risks. Clinicians must adopt comprehensive strategies, integrating anatomical insights and advanced imaging, to optimize aesthetic outcomes in masseter hypertrophy management."

Journal

Cross induction of anti-complexing antibodies in botulinum treatment patients injected with botulinum toxin containing complexing proteins (AAD 2025) - "One-hundred participants were divided into 5 subgroups for using 5 types of BoNT/A (incobotulinumtoxinA(IncoA), onabotulinumtoxinA(OnaA), abobotulinumtoxinA(AboA), letibotulinumtoxinA(LetiA), and prabotulinumtoxinA(ProboA). AboA which has difference molecular weight can induce only some type of antibody against CPs. IncoA which do not contain complexing protein is not induced antibody against CPs."

Clinical

Hugel wins UAE approval for botulinum toxin Botulax (PRNewswire) - "Hugel Inc...said on Wednesday it received approval for its botulinum toxin Botulax with aesthetic and therapeutic applications from the United Arab Emirates (UAE) on January 20, achieving a significant milestone for the company's global expansion...The approval of Botulax in 50IU, 100IU, and 200IU covers five aesthetic and medical indications: eyelid spasm; crow's feet; glabellar lines; upper extremity muscle spasticity after stroke; and cerebral palsy adduction deformity in children."

Approval • CNS Disorders • Dermatology • Muscle Spasticity

A Novel Technique for the Topical Application of Botulinum Neurotoxin A to the Nasal Mucosa in Reducing Rhinitis Symptoms. (PubMed, Cureus) - "Topical application of BTA on the nasal mucosa can be considered an effective therapeutic option in patients with persistent AR and idiopathic rhinitis. In comparison with injection techniques, BTA mucosal spray is effective at reducing persistent symptoms while minimizing the risk of pain and inadvertent systemic injection, and is able to promote contact with a wider mucosal area. Furthermore, it is easy to perform and is more tolerable for the patient. The authors present recommended concentrations, doses, and techniques."

Journal • Allergic Rhinitis • Immunology • Inflammation • Pain

Consensus Recommendations for Treatment of the Upper Face With LetibotulinumtoxinA. (PubMed, Plast Aesthet Nurs (Phila)) - "The panelists provided recommendations for treating forehead horizontal lines, glabellar frown lines, and lateral canthal lines. The guidelines developed by the panel will support clinical practitioners of all skill levels in providing safe and effective aesthetic treatments of the forehead, glabellar complex, and lateral canthal lines with letibotulinumtoxinA."

Journal • Aesthetic Medicine

Investigating the impact of botulinum toxin type a on the migration of normal human dermal fibroblasts: An in vitro wound healing assay. (PubMed, J Cosmet Dermatol) - "Different types and dilutions of BoNT-A demonstrated variable inhibitory effects on NHDF migration in vitro. The selection of BoNT-A formulation may significantly impact the clinical outcome of scar prevention related to fibroblast migration."

Journal • Preclinical • Fibrosis • Immunology

Comparative Study on the Duration and Efficacy of Various Botulinum Toxin Type A Injections for Reducing Masseteric Muscle Bite Force and Treating Facial Wrinkles. (PubMed, Dermatol Ther (Heidelb)) - "The structural differences among BoNT/A brands did not significantly affect the longevity and efficacy of bite force reduction and wrinkle treatment."

Journal • Aesthetic Medicine

Efficacy and Safety of LetibotulinumtoxinA in the Treatment of Moderate and Severe Glabellar Lines in Females 35 to 50 Years of Age: Post Hoc Analyses of the Phase 3 Clinical Study Data. (PubMed, Aesthet Surg J Open Forum) - "Response rates remained higher up to Week 16. The treatment demonstrated efficacy and safety in treating vertical glabellar lines in this patient group."

Journal • P3 data • Retrospective data

LetibotulinumtoxinA Attenuates the Psychological Burden of Glabellar Lines and Is Associated With High Subject Satisfaction in Phase 3 Clinical Trials. (PubMed, Dermatol Surg) - "LetibotulinumtoxinA significantly improved the psychosocial burden associated with glabellar lines across all trials. Treated subjects experienced improved quality of life, younger perceived age, and satisfaction with treatment outcome."

Journal • P3 data

Commentary on: Use of LetibotulinumtoxinA for Aesthetic Treatment of Asians: A Consensus. (PubMed, Aesthet Surg J) - No abstract available

Journal • Aesthetic Medicine

"@Channel7 why are you advertising new cosmetic injectable schedule 4 medications on your evening news program as news articles? Your segment on Letybo letibotulinumtoxinA was not news but a bald faced drug advertisement. @TGAgovau @acccgovau" (@tev_mek)

The effect of botulinum toxin type A on normal human dermal fibroblasts in an in vitro wound healing assay (WCD 2023) - "Then, the scratched NHDF monolayer was treated with varying concentrations of 10, 20, 25, 40, 50 and 100 units/milliliter (U/ml) of onabotulinumtoxinA (ONA), letibotulinumtoxinA (LETI), prabotulinumtoxinA (PRABO) and incobotulinumtoxinA (INCO) and 33, 50, 66, 71, 100, 150, 300, and 500 U/ml of abobotulinumtoxinA (ABO). Different types and dilution of BoNT-A provided variable inhibitory effects on fibroblast migration in vitro. The selection of BoNT-A used may influence the clinical outcome for scar prevention"

Late-breaking abstract • Preclinical • Fibrosis • Immunology

Differences in antibody responses of intradermal and intramuscular injections of botulinum toxin type A (WCD 2023) - "MATERIALS AND One hundred subjects were divided into intradermal and intramuscular groups, and each group was equally divided into 5 subgroups for using 5 types of BoNT/A (incobotulinumtoxinA, onabotulinumtoxinA, abobotulinumtoxinA, letibotulinumtoxinA, and prabotulinumtoxinA). Intramuscular BoNT/A injections could be preferable for facial treatment to reduce the antibody against BoNT/A formation"

Botulinum toxin for limb dystonia (Lecture) (ASNA 2023) - No abstract available.

A Multi-center Phase II Study Evaluating the Safety and Efficacy of Botulax® in Asian Patients with Benign Masseteric Hypertrophy. (PubMed, Plast Reconstr Surg) - "BTA administration of at least 48U for BMH is more cost-effective than high-dose units and has a low possibility of side effects."

Journal • P2 data

Use of LetibotulinumtoxinA for Aesthetic Treatment of Asians: A Consensus. (PubMed, Aesthet Surg J) - "Panelists proposed individualized treatment plans for botulinum toxin type A (BTxA) in three aspects of wrinkle removal, contour adjustment, and face lifting in Asians based on their extensive experience and facial anatomy. When using different BTxA, clinicians should start with a conservative dose and carefully individualize the treatment for each patien and adjust it according to the feedback to obtain a higher satisfaction level."

Journal • Aesthetic Medicine

Cosmetic Treatment Using Botulinum Toxin in the Oral and Maxillofacial Area: A Narrative Review of Esthetic Techniques. (PubMed, Toxins (Basel)) - "There are several FDA-approved BoNTs (obabotuli-numtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, letibotulinumtoxinA, prabotulinumtox-inA, daxibotulinumtoxinA, rimbotulinumtoxinB) and novel BoNTs on the market...This paper can serve as a practical illustrative guide and reference for optimal, safe injection areas and effective doses for application of BoNT in the face and oral and maxillofacial area. The history of BoNT indications, contraindications, and complications, and the merits of ultrasonography (US)-assisted injections are also discussed."

Journal • Review • Aesthetic Medicine • Immunology

"Croma Australia Pty Ltd, a subsidiary of Hugel Aesthetics, Receives TGA Approval in Australia for LETYBO (letibotulinumtoxinA) for the Treatment of Glabellar Lines https://t.co/lmtJcYYayN" (@NewsFromBW)

"Hugel Aesthetics Receives FDA Acceptance of BLA Resubmission for LetibotulinumtoxinA for Injection for Glabellar Lines https://t.co/hVw4etBUb4" (@NewsFromBW)

FDA event

Phase 3 Clinical Study of Efficacy and Safety Assessment of Botulax® and BOTOX® for Improvement of Glabellar Lines. (clinicaltrials.gov) - P3 | N=500 | Completed | Sponsor: Hugel

New P3 trial • Immunology

Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: Hugel | Not yet recruiting ➔ Completed | Trial completion date: Jul 2020 ➔ Oct 2021 | Trial primary completion date: Jul 2020 ➔ Apr 2021

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Dystonia • Movement Disorders

Evaluate the Safety and Efficacy of Botulax® Versus Botox® in Patient With Overactive Bladder (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: Hugel | Recruiting ➔ Completed | Trial completion date: Jun 2020 ➔ Oct 2021 | Trial primary completion date: Jun 2020 ➔ Apr 2021

Trial completion • Trial completion date • Trial primary completion date • Overactive Bladder

Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines (clinicaltrials.gov) - P3 | N=240 | Completed | Sponsor: Hugel | Recruiting ➔ Completed

Trial completion

Efficacy and Safety of Letibotulinum Toxin A in the Treatment of Glabellar Lines: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study. (PubMed, Aesthet Surg J) - "Letibotulinumtoxin A demonstrates high efficacy and a convincing safety profile in the treatment of glabellar lines."

Clinical • Journal • P3 data

Practical Application of Novel Test Methods to Evaluate the Potency of Botulinum Toxin: A Comparison Analysis among Widely Used Products in Korea. (PubMed, Toxins (Basel)) - "Four types of BoNTs (prabotulinumtoxin A, onabotulinumtoxin A, neubotulinumtoxin A, and letibotulinumtoxin A) were used in this study. The results showed differences in the total amount of BoNT protein and the cleavage activity of SNAP-25 within all types of BoNTs. The SPR study seemed to be useful for evaluating the potency by specifically measuring intact 19S neurotoxin, and these results provide new insights for assessing different BoNT products."

Journal