Next generation Botox approved by FDA
Juvederm, a hyaluronic acid dermal filler, claims to provide smoother, longer-lasting results than competitive products.
According to Allergan, its new gel family of products can deliver
sustained results for up to six months longer than other products, due
to its higher concentrations of non-animal and cross-linked hyaluronic
Occurring naturally in the body, hyaluronic acid is a natural
complex sugar found in all living organisms and creates volume and
elasticity in the skin.
With the FDA approval, Juvederm is now set to join Botox as an
alternative semi-permanent anti-wrinkle treatment, tapping into a
market that is fast-growing in both North America and Europe. In 2004
more than 7.5 million non-invasive procedures were performed in the
United States, up 36 per cent from 2000, according to the American
Society of Plastic Surgeons.
Allergan claims its new formulation is natural, biodegradable and
currently the only approved hyaluronic acid dermal filler that has
demonstrated its safety and effectiveness in patients of all skin types
It also claims to be the only hyaluronic acid dermal filler
developed using a proprietary, technologically advanced manufacturing
process that results in a malleable smooth gel that flows easily into
the skin, creating a smooth, natural look and feel. According to the
company, all other currently approved hyaluronic acid dermal fillers
utilize a gel particle suspension formulation.
"It is very exciting to have a new facial rejuvenation tool with the
unique qualities of Juvederm that we can now offer to our patients. Our
clinical investigation found Juvederm to be a smooth-flowing injection
that provides our patients with a natural appearing result. The new
formulation of hyaluronic acid offers physicians a high level of
control for facial contouring," said Gary Monheit, Juvederm clinical
The FDA approved three different formulations for Juvederm. These
are Juvederm 24HV, for more versatility in contouring and volumizing of
facial wrinkles and folds; Juvederm 30HV, for volumizing and correction
of deeper folds and wrinkles; and Juvederm 30, for subtle correction of
facial wrinkles and folds.
Juvederm, which must be administered by a qualified health care
provider, adds volume to facial wrinkles. In contrast, Botox relaxes
the dominant frown muscles between the eyebrows, allowing the two
vertical lines between the brows to temporarily diminish in appearance.
The FDA's approval of Juvederm was based on data from a
double-blind, randomized and controlled clinical trial. A total of 439
subjects were followed for six months after injection with one of three
Juvederm formulations in one nasolabial fold, and Zyplast, a
bovine-based collagen, in the other.
Allergan said the tests revealed that Juvederm was found to provide
a more persistent wrinkle correction than Zyplast over the 6-month
course of the study, with up to 90 percent of subjects maintaining at
least a 1-grade improvement in nasolabial fold correction with Juvederm
compared to 36-45 percent with Zyplast.
At the conclusion of the study, up to 88 percent of subjects
expressed a preference for Juvederm while only 5-12 percent expressed a
preference for Zyplast.
The company said it is currently finalizing the presentation of the
products, and is due to announce availability dates later this year.