The USFDA yesterday confirmed that it has approved of Botox Cosmetic for the temporary treatment of fine lines around the eye area, commonly known as crow’s feet.
In an official statement, the government body said that after a significant time of deliberation it has chosen to approve the treatment for moderate to severe lateral canthal lines, making it the only FDA approved drug to treat crow’s feet.
The approval of Botox for the treatment of crow’s feet is expected to give a big boost to its manufacturer, Allergan, which has enjoyed tremendous success since it was first given FDA approval more than ten years ago.
Allergan stands to get boost from new approval
The company currently has an annual revenue stream in excess of $1 billion, which is driven by Botox, its leading brand.
Botox was initially given the green light by the FDA back in 2002 for the treatment of glabellar lines, which are the frown lines on the forehead, between the eyes.
The treatment was originally devised to treat muscle spasms back in the 1950s, thanks to its ability to freeze any area where patients had involuntary movements. But it was later discovered that the treatment also served to freeze wrinkles and diminish their appearance.
The treatment actually works on wrinkles because it ‘freezes’ the treated area, which preventing the facial muscles from tightening, which in turn means that wrinkles are less likely to be apparent.
FDA points to positive outcome of clinical trials
Traditionally the treatment for frown lines is administered through intramuscular injections, and the approval for the treatment of crow’s feet is for the same means of treatment and also stipulates that both areas can be treated at the same time.
The FDA approval has been based on clinical trials involving 833 adults who had enrolled for the treatment of moderate to severe lateral and canthal lines. Volunteers were randomly assigned either the Botox treatment or a placebo.
The results showed significant improvement in the appearance of crow’s feet, when compared to the placebo, while the most common adverse reaction to the treatment was eyelid edema, which consists of swelling and excessive fluid, but is usually only temporary.
Allergan expands its business portfolio
At the end of last year, Allergan acquired SkinMedica in a deal that saw the company make an upfront payment of $350m for the business, which was part of efforts to diversify its portfolio.
SkinMedica’s business includes a variety of physician dispensed and non-prescription aesthetic skin care and prescription products, although the deal does exclude SkinMedica’s Colorscience aesthetic make-up line, which will be spun off in a separate deal.
Allergan also pledged a further $25m as part of the deal, taking the total acquisition price up to $400m, if SkinMedica achieves certain interim sales targets.