RelabotulinumtoxinA, a Ready-to-Use Formulation Neuromodulator Manufactured with PEARL™ Technology to Maintain High...

Area of Science:

• Biochemistry and Molecular Biology
• Dermatology and Aesthetic Medicine
• Microbiology and Toxinology

Background:

• Most aesthetic botulinum toxin A (BoNT-A) products require reconstitution, posing handling and stability challenges.
• RelabotulinumtoxinA is a novel, ready-to-use liquid BoNT-A formulation developed with proprietary Precipitation-free Extraction and Activity-preserving, Refined Liquid (PEARL™) Technology.

Purpose of the Study:

• To characterize the in vitro properties of relabotulinumtoxinA.
• To compare relabotulinumtoxinA with a powder-based BoNT-A formulation (onabotulinumtoxinA) in terms of potency, enzyme activity, and biological function.

Main Methods:

• Quantification of BoNT-A1 content using ELISA.
• Assessment of specific enzyme activity via SNAP-25 cleavage assay (BoTest®).
• Evaluation of biological activity (binding, internalization, SNAP-25 cleavage) using cell-based assays.

Main Results:

• RelabotulinumtoxinA demonstrated higher BoNT-A1 content per dose and greater specific enzyme activity compared to onabotulinumtoxinA.
• In vitro, relabotulinumtoxinA exhibited enhanced biological activity, including earlier onset of SNAP-25 cleavage.
• The PEARL™ Technology yields a high-quality BoNT-A1 with superior specific enzyme and biological activities.

Conclusions:

• RelabotulinumtoxinA possesses robust in vitro characteristics, including high potency and activity, attributed to the PEARL™ Technology.
• These findings provide a scientific basis for the observed clinical performance of relabotulinumtoxinA in treating glabellar lines and lateral canthal lines.