Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today announced two newly published peer review studies in Aesthetic Surgery Journal that provide supportive evidence of the safety and efficacy of repeat doses of prabotulinumtoxinA (Jeuveau®) to decrease the appearance of glabellar lines, also known as frown lines between the eyes. The two Phase II studies, conducted to support the registration and regulatory approval of Jeuveau in the United States, Canada and Europe, demonstrate that prolonged use of Jeuveau is safe and effective with repeat treatments. The studies also reveal that the patented Hi-Pure™ manufacturing technology used to make Jeuveau is not associated with antibody formation or neutralizing antibody formation.
“These peer reviewed studies add to the evidence base that repeat doses of Jeuveau are safe for patients and complement the results of the Phase III studies conducted for Jeuveau. Importantly, it’s reassuring to see the adverse event rates decreasing with each subsequent treatment,” said Rui Avelar, Chief Medical Officer and Head of Research & Development and an author of the study publications. “This is significant because consumers typically receive repeat treatment over time and want assurances that the product is safe and will continue to work. These results validate the positioning of Jeuveau as an exciting option for providers and consumers looking for an alternative neurotoxin for aesthetic use.”
Both studies were long-term (one-year), open-label, phase II studies designed to investigate the safety of repeat doses of 20 U prabotulinumtoxinA for the treatment of glabellar lines. The complementary studies primarily differed in the number of patients and in the product formulation process employed (freeze-dried in EV-004; vacuum-dried technology in EV-006). In both studies, among study completers, there was no evidence of shortening retreatment periods that might suggest immunogenicity and/or the development of resistance; in fact, the opposite was observed, with a trend towards longer retreatment periods. This is important because, when treating patients with a biological agent, a shortening time interval between treatments may be suggestive of increasing resistance or antibody development. In addition, the percentage of patients who experienced an adverse event (AE) after treatment decreased with repeat exposure. The most reported AE was headache. There were no serious adverse reactions related to the drug.