Evolus Inc announces two peer review studies published in Aesthetic Surgery Journal that provide supportive evidence of the safety and efficacy of repeat doses of prabotulinumtoxinA (Jeuveau) to decrease the appearance of moderate to severe 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.
“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.”
— Rui Avelar, Chief Medical Officer and Head of Research & Development and an author of the study publications
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, a media release from Evolus explains.
The two Phase II studies in reference can be accessed here:
[Source(s): Evolus, GlobeNewswire]
