Daewoong Pharmaceutical announced on November 10 that Evolus, its U.S. and European partner in the botulinum toxin formulation business, has announced the final results of a Phase 2 clinical trial of a high-dose toxin.
Evolus confirmed the 6-month (26-week) long-lasting effects of high-dose 40-unit Jeuveau (the U.S. product name for Nabota) through a Phase 2 clinical trial, which was presented at the American Society for Dermatologic Surgery (ASDS) meeting in Chicago on November 3.
The trial utilized the Glabellar Line Scale (GLS) to measure the improvement and sustained effectiveness of the high-dose 40-unit Jeuveau in reducing glabellar wrinkles.
Effectiveness was measured by the length of time it took for patients to return to their original Glabellar Line Scale after treatment, based on the patient's Glabellar Line Scale at maximum frowning, the duration of effect for patients who showed improvement in Glabellar Line Scale, and the post-treatment Global Aesthetic Improvement Scale (GAIS).
In this study, the active control of 40 units of Jeuveau was compared to 20 units of Botox and 20 units of Jeuveau, with similar adverse event results to the active control. No serious adverse events were noted, according to the company.
Evolus previously announced interim results from the 40-unit Jeuveau Phase 2 trial in June, which showed six-month long-lasting results.
With the successful completion of the Phase 2 trial, Evolus will be able to provide patients with more options and strengthen its global product competitiveness with the high-dose 40-unit Jeuveau treatment cycle flexibility.
"This clinical trial demonstrated the long-lasting effectiveness and safety of Jeuveau," said Dr. Park Sung-soo, Vice President of Daewoong Pharmaceuticals. "Daewoong and Evolus will continue to expand our global market share."
