Study finds Evolus neuromodulator comparable to Botox
The neuromodulator prabotulinumtoxinA from Evolus Inc. (Santa Barbara, Calif.) was found comparable to Botox in treating moderate to severe glabellar lines, according to a multicenter Phase III study.
The trial also met its secondary endpoint of patient satisfaction.
“We are very pleasantly surprised with the results. They are consistent with the Korean Phase III study, which also hit its primary endpoint against Botox,” says Rui Avelar, M.D., chief medical officer of Evolus.
To date, over 2,100 people have been enrolled in the company’s neuromodulator clinical program, “so we have a very good sense of how the drug works,” Dr. Avelar tells The Aesthetic Channel. “In addition, most of the adverse events are mild in nature, which means it is less than a minor injury, an inconvenience or a temporary discomfort. Importantly, there have been no serious adverse events attributed to our neuromodulator.”
The Evolus product is similar to Botox. “Both drugs are 900 kilodalton (kDa) complex toxins, with the same active toxin and accessory proteins, and both have the same excipients (ingredients) in the bottle,” Dr. Avelar explains. “Both drugs have the same mechanism of action.”
A total of 540 study patients were randomized at a ratio of 5:5:1 to a single treatment of the Evolus product, Botox or placebo.
The responder rates were 87.2%, 82.8% and 4.2%, respectively.
Similarly, the percentages of subjects experiencing adverse events considered drug-related were 15.5%, 14.6% and 4.1%, respectively.
The company believes that the market “would like to have a new, evidence-backed aesthetic neurotoxin alternative to other neurotoxins such as Botox,” Dr. Avelar says. “We hope to gain FDA approval later this year, so we can offer a product for the treatment of glabellar lines.”
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