Inamed Corporation and Genzyme Corporation announced that the U.S. Food and Drug Administration (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). No pre-treatment skin test is required and shipments of Hylaform gel are anticipated to begin immediately.
"Hylaform gel is a key addition to our broad and comprehensive pipeline of facial aesthetic products," said Hani Zeini, executive vice president, Inamed Aesthetics. "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 in the United States."
"With this approval, Inamed is the only company to offer a comprehensive portfolio of collagen dermal fillers and a hyaluronic acid-based dermal filler," added Zeini. "Hylaform now joins our established collagen franchise of CosmoDerm/CosmoPlast and Zyderm/Zyplast dermal fillers to provide a full range of products that meet both patient and physician needs to achieve optimal facial aesthetic results."
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 was developed and is being manufactured by Genzyme Corporation. Inamed is Genzyme's exclusive worldwide marketing and distribution partner for Hylaform.
"We are very pleased that the FDA has approved Hylaform gel and made it available to patients looking for alternative dermal fillers," said Ann Merrifield, President Genzyme Biosurgery. "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 here in the U.S."
"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."
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 approval of Hylaform gel expands Inamed's current dermal filler product offering in the United States, which already includes CosmoDerm and CosmoPlast human-collagen, approved in March 2003 by the FDA as the first dermal fillers that do not require a pre-treatment skin test.
The Company's Zyderm and Zyplast bovine-based collagen dermal fillers are considered by many to be the "Gold Standard" in the treatment of soft tissue contour deficiencies. In January 2004, through a licensing agreement with Corneal Group, the Company expects to add the Juvederm range of hyaluronic acid-based, cross-linked, homogeneous gel products to its U.S. portfolio following clinical trials and FDA regulatory approval. Additionally, Inamed's Botulinum toxin type A product, licensed from its partner Ipsen for cosmetic indications, is in clinical development in the United States.
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.