In 1989, the U.S. Food and Drug Administration approved botulinum toxin for two rare eye muscle disorders in adults, blepharospasm (eye twitching) and strabismus (crossed eyes). The drug, then called Oculinum, was sold by a research scientist, Alan Scott, to Allergan for $9 million in 1991, which rebranded it Botox.
In 2002, the FDA approved botulinum toxin injections for cosmetic use, thereby sparking a cultural phenomenon that ranged from Botox parties, Botox gift cards, and, of course, Botox humor:
According to the American Academy of Dermatology, Botox Cosmetic is a toxin injected into facial muscles causing paralysis that relaxes wrinkles and smoothes foreheads. It has so many other legitimate and off-label uses that it has become the top non-surgical procedure performed in the U.S.
- Market dimensions – Due to the pandemic, the data cited here reflects 2019, a more representative year. In 2019, 5 million injections of botulinum toxin type A, which includes Botox, Dysport, and XEOMIN, were administered, according to the American Society of Plastic Surgeons, making it the top non-surgical procedure performed worldwide.
- Competition – The company that markets Botox, Dublin, Ireland-based Allergan, is the market leader. In 2019, the company generated $3.8 billion in Botox sales, with therapeutic category sales rising 4.9% to $2.1 billion, while cosmetic sales grew 7.4% to $1.7 billion. Allergan’s closest competitors are Galderma Laboratories’ Dysport and XEOMIN, from Germany-based Merz Pharma, but neither is a match for Botox in sheer market awareness.
- Approved treatments – Besides its application for the treatment of movement disorders, botulinum toxin type A was approved by the FDA in 2002 to treat moderate-to-severe frown lines between the eyebrows — called the glabella or the “11s” — and crow’s feet (2013). Botox is also used to treat a number of other ailments, including hyperhidrosis (excessive sweating), migraine headaches, weak bladder symptoms, and muscle stiffness.
- Off-label use – Other uses include horizontal forehead lines, crow’s feet and the tiny “bunny lines” on each side of the upper nose.
Allergan’s Botox revenues have more than doubled from the $1.4 billion recorded in 2008. Not bad for a drug named after the Latin word for sausage, botulus, due to the toxin’s first discovery in poorly prepared sausages during the 18th century. 😍