For those considering taking a needle to reduce wrinkles, there's a new product that claims to last twice as long as Botox, which has dominated the market for decades.
The Food and Drug Administration on Thursday approved the anti-wrinkle injection Daxxify.
Drug manufacturer Revance Therapeutics says its studies show Daxxify can temporarily improve moderate to severe frown lines for about six months, almost twice as long a period as Botox.
According to Revance, 98% of patients during trials had no wrinkles or mild wrinkles at four weeks after injection. Results were seen as early as one day after treatment, typically seen within two days, and lasted six months -- with some patients seeing results for as long as nine months, the drug maker said.
"Most importantly, Daxxify has the ability to address duration of treatment effect, which we believe is the greatest unmet need with existing [products]," the drug maker said in a statement.
Revance says patients who have been accustomed to receiving conventional injections such as Botox every three to four months could achieve year-long results with as few as two treatments of Daxxify per year.
Health experts say Daxxify was generally safe and well tolerated, with no serious treatment-related adverse events reported in the clinical trials.
The drug "achieved clinically significant improvement with long-lasting results and high patient satisfaction," the company said.
The FDA approval is Revance's first.
The U.S. market for facial injectables is worth a growing $3.2 billion. Botox, which was approved for cosmetic procedures in 2002, holds about 70% market share, according to The Wall Street Journal.
Cowen Inc. analyst Ken Cacciatore told WSJ that Daxxify is expected to generate $1 billion in sales as early as 2030.
"This marks what we think is the first real competitive threat to Botox," Cacciatore said.
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