Allergan announces the FDA approval of JUVÉDERM® VOLUMA™ XC for use in the chin region to improve the chin profile.
Allergan, an AbbVie company, recently announced the U.S. Food and Drug Administration (FDA) approval of JUVÉDERM® VOLUMA™ XC for use in the chin region to improve the chin profile in adults 21 years and older.
"When assessing facial anatomy, the chin is a critical component to facial balance, yet it is often overlooked. Due to its distinct gel properties and product profile, JUVÉDERM® VOLUMA™ XC is uniquely suitable to address this need," says Carrie Strom, Senior Vice President, AbbVie, and President, Global Allergan Aesthetics.
The product is the first and only filler to receive FDA approval for the chin and marks the JUVÉDERM® Collection of Filler’s fifth approved indication in the United States, according to the press release announcing the approval. VOLUMA™ XC was previously approved in 2013 to correct age-related mid-face volume deficit and can last up to two years.
The U.S. pivotal study for VOLUMA™ XC for chin augmentation showed the product to be safe and effective. Researchers reported high satisfaction from the majority of study participants after one year, according to the release.
Recorded adverse events (AEs) in the study showed less than 5% of patients experienced tenderness, firmness, swelling, lumps, pain, bruising, redness, discoloration or itching. Of those AEs that did occur, most were mild to moderate in severity and resolved in two to four weeks.
"It's always rewarding when we can offer a safe and effective non-surgical alternative to patients,” says Strom. “Addressing chin contour and shape is another way we are moving the market forward through our commitment to continued innovation."