FDA approves Hylaform gel acid-based dermal filler for correction of facial wrinkles
SANTA BARBARA, CALIF. & CAMBRIDGE, MASS., April 23, 2004 -- Inamed Corporation and Genzyme Corporation announced that the FDA has granted market approval for Hylaform (hylan-B gel), a hyaluronic acid-based dermal filler that is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
Inamed says the product has a proven record in countries around the world over nearly a decade.
Hylaform gel is a clear, colorless gel made from purified hyaluronic acid, a naturally occurring substance (complex sugar) found throughout all living organisms. Hyaluronic acid (HA) is chemically, physically and biologically similar in all species. In the skin, hyaluronic acid fills the space between collagen and elastin fibers -- replenishing the natural volume lost during aging -- while delivering essential nutrients and hydration. The body naturally absorbs Hylaform gel over time.
"Hylaform gel is a new option for patients looking for effective, non-surgical aesthetic facial treatment," said Ellen Gendler MD, and a Hylaform U.S. clinical trial investigator. "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. My patients reported great satisfaction with results and no downtime from the treatment. I think Hylaform will quickly become a staple in my practice, especially as we begin to use multiple dermal filler products to replace the collagen and hyaluronic acid lost as skin ages."
Hylaform gel is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). The most commonly reported adverse events during the Hylaform clinical study included erythema, bruising and swelling which typically were mild in severity and procedure related.
The safety and effectiveness of combination use of collagen and HA products have not been evaluated in clinical studies.
Full prescribing information for Hylaform may be obtained by visiting www.Inamed.com
Source: Inamed Corporation
Posted: April 2004