Merz Aesthetics aims to lead safe BTX use with ‘global agreement’

As the use of botulinum toxin (BTX) continues to grow globally, dermatologists stressed the crucial role of highly purified BTX in treating numerous neurological conditions effectively.

In light of this, Merz Aesthetics held a press conference in Seoul on Monday to announce the “global agreement” for the safe use of BTX reached by the members of the Aesthetic Council for Ethical Use of Neurotoxin Delivery (ASCEND).

Established in 2021, ASCEND aims to raise awareness of the need to inform patients accurately about the growing issue of BTX resistance.

This led to the presentation of a paper on "International Multidisciplinary Review and Consensus on Current Trends in Botulinum Toxin Resistance" at IMCAS Asia 2022 last year which Apgujeong Oracle Dermatology Clinic Chief Director Park Je-young presented.

According to Park, there is a lack of published papers regarding the use of BTX in aesthetic applications. However, there is a significant body of literature on the use of BTX for therapeutic indications.

The crucial factors for successful treatment, whether for therapeutic or aesthetic purposes, are the dose and purity of the injections. As such, neutralizing antibody (NAb) resistance data from therapeutic studies can be extrapolated and applied to aesthetic studies, he said.

Park went on to say that many also believe they do not need to be concerned with resistance because the aesthetic field generally uses lower doses.

However, among younger people in their 20s and 30s receiving treatments for body contouring these days, the dosage accumulation can eventually lead to immune resistance one to three years later, he warned.

Expressing Korea’s efforts to create a healthy BTX environment, he noted the Korea Disease Control and Prevention Agency’s (KDCA) revised guidelines for strengthening the safety management of bioterrorism pathogens in 2021. 

Additionally, he mentioned the infectious disease prevention act which is currently being revised by the Nationally Assembly, and the Ministry of Food and Drug Safety’s cancellation of six BTX product licenses with stricter regulations.

Specifically, Dr. Michael Martin, an immunologist and a retiree who used to work at the University of Giessen, elucidated the mechanism of action, stating that a BTX product has been purified to remove unwanted components such as complex proteins and bacterial DNA contaminants.

”BTX is an effective treatment for many medical or neurological conditions, including spasticity of the limbs, cervical dystonia, and chronic migraines, so it is important to use the highly purified toxin, as BTX resistance can narrow a patient's future treatment options," Martin said.

From a clinician’s perspective, Dr. Pacifico Calderon of St. Luke's Medical Center School of Medicine stressed the importance of discussing the patient’s BTX treatment history and selecting a toxin product with a reliable safety profile to enable a patient-centered approach and informed decision-making.

Merz Aesthetics’ Chief Science Officer Samantha Kerr said the company completed clinical studies in China for glabellar lines which are now under review by the China FDA, in addition to another phase 2 clinical trial in the U.S. for the upper facial lines program.