New injectable targeting smile lines gets FDA approval

By Simon Pitman

- Last updated on GMT

Related tags: Pharmaceutical drug, Botulinum toxin

US company Sanofi-avantis says its Sculptra Aesthetic facial injection treatments targeting smile lines and other deep wrinkles have been given FDA approval.

The product, which is an implant of poly-L-lactic acid (PLLA) microparticles, is injected into the facial tissue to correct shallow to deep smile lines - also know as the nasolabial fold – as well as contour deficiencies and other facial wrinkles.

According to the company’s FDA approval summary, ‘Sculptra Aesthetic works by initially filling a wrinkle with small PLLA beads. As the beads break down, the body may produce collagen where Sculptra Aesthetic is injected’.

When the treatment is administered by a qualified doctor to people with healthy immune systems, four injections sessions scheduled three weeks apart are said to provide a reduction in signs of wrinkles that last for up to two years.

Clinical trials compared well to collagen treatments

The company says that it conducted a clinical study that compared the treatments to a standard collagen injection, with favorable results.

Conducting four injection sessions over a nine week period helped to keep facial lines smoother for up to 25 months, compared to just three months for the regular collagen injection treatment.

However, the company also points out, that, unlike other collagen-based injections, the treatment cannot be carried out on finer or sensitive areas of the face, specifically around the eyes.

The study also showed that the treatment sometimes led to mild or moderate outbreaks of lumps or bumps that generally resolved of their own accord.

The product that dominates the injectables market is Botox, which is currently the only type A botulinum toxin product approved for aesthetic use in the US.

In 2007 sales of the product totalled $1.21 bn, with sales of the product for aesthetic use increasing by 29 per cent.

The market growth for injectable cosmetics treatments has continued to grow, even in the face of the economic recession, although more and more rivals means the market place for this category is getting increasingly crowded.

Related topics: Market Trends

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