Galderma receives marketing authorisation for Relfydess™ in Germany: first ready-to-use liquid neuromodulator for the treatment of frown lines and crow's feet
Galderma has received approval for Relfydess™ (RelabotulinumtoxinA) in Germany – the first ready-to-use liquid botulinum toxin, developed with the patented PEARL™-technology. This innovative technology (Precipitation-free Extraction and Activity-preserving Refined Liquid) makes it possible to produce a highly purified, complex-free botulinum toxin without the addition of animal proteins, allowing consistent and stable efficacy to be achieved. By eliminating the reconstitution step, Relfydess™ offers a practical and precise option for
aesthetic treatments.
Of the READY-study series, the READY-1-study has since been published and is presented below.
RelabotulinumtoxinA (RelaBoNT-A) was developed by Galderma so that a new liquid formulation can make precise aesthetic treatments with a lower immunological risk possible. The PEARL™-technology underlying the formulation eliminates the need for complexing proteins that are present in conventional toxin preparations. This manufacturing method preserves the natural structure of the toxin and thus promises stable and long-lasting efficacy.
The READY-1-study was a six-month, multicentre, double-blind, placebo-controlled Phase-III-study. The study enrolled 300 adults with moderate to severe glabellar lines, who were randomised in a 3:1 ratio to receive either 50 units of RelaBoNT-A or placebo. The primary endpoint for the USA was an improvement of at least two grades in line severity, as assessed by independent investigators and participants. For approval in Europe, an improvement in the lines of at least one grade was assessed by investigators. Additional endpoints included duration of efficacy, treatment satisfaction and adverse event rate.
A total of 297 patients were randomised and treated. After one month, the responder rate with an improvement of at least two grades was 82.9% in the RelaBoNT-A- group (n = 199) compared with 0% in the placebo group (n = 67; P < 0.001). The investigator-reported responder rate of “none or mild” severity was 96.3% in the first month in the RelaBoNT-A-group compared with 4.5% in the placebo group (P < 0.001). The GL-ILA-values (Glabellar Line Investigator Live Assessment – real-time assessment of the glabellar lines by the investigator) remained higher in the RelaBoNT-A-group up to month six (23.6% with “none or mild” severity; 58.1% with an improvement of at least one grade) compared with the placebo group (1.5% and 10.4%, respectively; P < 0.001). In the Kaplan-Meier-analysis, 75% of participants continued to show improvements in the GL-ILA- and GL-SLA-values (Glabellar Line Subject Live Assessment – real-time assessment of the glabellar lines by the participants) compared with baseline on day 169 (end of study). Participants reported onset of effect from day 1 (39%) and were highly satisfied with the natural-looking results (96.8%; month 1). Adverse events related to RelaBoNT-A (TEAEs) were rare (3.6%) and typically mild.
Source:
Shridharani, S. M., Moradi, A., Donofrio, L., Gold, M. H., Biesman, B., Chiang, M., George, R., Polder, K., Solish, N., Schwarcz, M., Lin, X., Axén, E., & Prygova, I. (2024). Efficacy and safety of RelabotulinumtoxinA, a new ready-to-use liquid formulation botulinum toxin: Results from the READY-1 double-blind, randomized, placebo-controlled Phase 3 trial in glabellar lines. Aesthetic Surgery Journal, 00(0), 1–11.
Mandatory prescribing information for Relfydess (healthcare professionals)
Summary of product characteristics (SmPC) as of: September 2024
Mandatory information as of: September 2024
Relfydess 100 units/ml solution for injection. Active substance: botulinum-toxin type A for injection (Ph.Eur.). Composition: 1 ml solution for injection contains 100 units of botulinum-toxin type A for injection (Ph.Eur.). Each vial contains 150 units in 1.5 ml of solution. The potency-units are specific to Relfydess and are not interchangeable with other botulinum-toxin-medicinal products. Excipients: disodium phosphate-dihydrate (Ph.Eur.), sodium dihydrogen phosphate-dihydrate, potassium chloride, sodium chloride, polysorbate 80 (E 433), tryptophan, water for injections. Therapeutic indications: Relfydess is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines at maximum frown and of moderate to severe lateral canthal lines seen at maximum smile, alone or in combination, in adult patients under 65 years of age, when the severity of these lines has an important psychological impact on the patient. Contraindications: Hypersensitivity to the active substance or to any of the excipients, presence of infection at the proposed injection site, presence of myasthenia gravis, Lambert-Eaton-syndrome or amyotrophic lateral sclerosis. Adverse reactions: Common (≥ 1/100, < 1/10): headache; eyelid ptosis; injection site reactions (e.g. bruising, erythema, swelling, pruritus, pain, discomfort, haematoma, hypersensitivity and warmth). Uncommon (≥ 1/1,000, < 1/100): hypersensitivity; visual impairment, dry eye, asthenopia, eyelid swelling; brow ptosis, urticaria; muscular weakness, muscle spasm. Warnings: Contains polysorbate. Prescription-only medicine. Pharmaceutical companies: Marketing authorisation holder: Ipsen Pharma, Boulogne- Billancourt (France), co-distributor: Galderma Laboratorium GmbH, Düsseldorf. As of: September 2024