"Hylaform gel is a key addition to our broad and comprehensive pipeline of facial aesthetic products. This product has a proven record in countries around the world for nearly a decade. We are excited to offer this new option to physicians and patients," said Inamed vice president Hani Zeini.
Hylaform is a clear, colourless gel made from purified hyaluronic acid (HA), a naturally occurring complex sugar found in all living organisms. In the skin, HA is claimed to fill the space between collagen and elastin fibers - replenishing the natural volume lost during aging.
Hylaform gel is injected into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
The companies claimed that the most commonly reported adverse events during the Hylaform clinical study were erythema, bruising and swelling which typically were mild in severity and procedure related.
"Hylaform gel is a new option for patients looking for effective, non-surgical aesthetic facial treatment. Hylaform demonstrated a favorable safety profile in clinical studies, which is supported by extensive worldwide post-marketing data. While redness, bruising and swelling are common adverse events seen with the use of HA dermal fillers, those associated with Hylaform were primarily mild," said Hylaform US clinical trial investigator Ellen Gendler.
Hylaform gel is one of a series of hyaluronic acid-based products developed by Genzyme.
"We are very pleased that the FDA has approved Hylaform gel and made it available to patients looking for alternative dermal fillers. Hylaform gel is now the newest in our series of hyaluronic acid-based products and we look forward to working with Inamed on a very exciting market launch in the US," said president of Genzyme Biosurgery Ann Merrifield.
The approval of Hylaform gel expands Inamed's current dermal filler product offering in the US, which already includes CosmoDerm and CosmoPlast human collagen, approved by the FDA in March 2003 as the first dermal fillers to not require a pre-treatment skin test.
At both this year's 62nd annual meeting of the American Academy of Dermatology and the recent annual meeting of the American Society for Aesthetic Plastic Surgery, physicians highlighted an emerging trend toward the combination use of dermal filler products such as collagen and hyaluronic acid-based products to achieve optimal aesthetic results.
The safety and effectiveness of combination use of collagen and HA products has not been evaluated in clinical studies however.