Abstract

Objectives: DelNova Inc. is developing ReViVox®, a first-in-class drug product to reverse undesirable conditions from neuromodulator procedures, including muscle paralysis/weakness manifesting as eyelid or brow ptosis, unnatural facial expression, and facial-feature misalignment. In doing so, ReViVox® will strengthen providers' and patients' confidence in neuromodulators. Introduction: Despite clinical efficacy of neurotoxins to reduce wrinkle severity, several adverse effects, such as eyelid and brow ptosis can occur. While hyaluronic acid dermal fillers have hyaluronidase, toxin has been left without an ‘eraser’ and there are currently limited methods to successfully combat these adverse effects. Materials / method: We report the first Phase 1 study in human subjects of local administration of an anticholinesterase for reversing undesirable muscle weakness which may arise following a neurotoxin treatment. In this proof-of-concept study, we investigated short-term effects of active ingredient (study drug) in ReViVox®, an anticholinesterase indicated for reversal of neuromuscular blockade in anesthesia. An anonymous survey was sent to aesthetic practitioners in the US (dermatologists, plastic surgeons, nurse practitioners) to gauge the level of support for a reversal product such as ReViVox®. Results: Our results demonstrate the study drug/active ingredient in ReViVox®, can be a potential candidate as a rescue agent to address the undesirable, localized outcomes of neurotoxin treatment. Similar results were reported in DelNova's preclinical studies. Survey responses were overwhelmingly in support of our product candidate, as a benefit to the aesthetic industry. Conclusion: The absence of a 'reverser' or 'touch-up' product to address possible undesirable outcomes following neuromodulator procedures is an unmet need in aesthetics. Our proof of concept studies, both preclinical and clinical; lay the foundation for formulation optimization. Our development of ReViVox® is practical, and based on a small molecule active drug substance which has been used clinically for treating other medical conditions of muscle weakness.