New Dermal Filler ‘Belotoro Balance’ Under FDA Review
Posted by Cosmetic Surgery Review on September 24, 2009
The U.S. Food and Drug Administration is currently reviewing a new dermal filler product called Belotero Balance. If approved, this injectable will join the likes of Juvederm, Perlane, Restylane and Prevelle Silk as an anti-aging treatment for moderate to severe wrinkles.
Belotero Balance is manufactured by Merz Pharmaceuticals, and is a “hyaluronic acid based monophasic gel” that works in a similar way as Restylane and Juvederm Belotoro Balance is designed to treat moderate to severe wrinkles in the face and neck area, and was first launched in Germany in 2005.
The filler has already been approved for aesthetic use as a wrinkle filler in the United Kingdom, Austria, Russia, Italy and Switzerland. The injectable can be used on almost any area of the face, and is designed to smooth out deeper wrinkles and grooves, create more attractive facial contours, and create a more youthful look.
According to Jack Britts, president and CEO of Merz Pharmaceuticals, LLC, “The FDA’s acceptance for review of the Belotero Balance PMA begins the application review process and signifies the beginning of Merz Pharmaceutical’s firm footprint in the American aesthetics market.” (Source: Drugs.com)
Belotero Balance is another non-animal stabilized hyaluronic acid filler that may be administered on an outpatient basis. Still, there are many things we don’t know about Belotero Balance. There are currently no published reports on whether Belotero Balance lasts longer than filler such as Restylane and Juvederm, or whether it is valuable for using as part of a ‘liquid facelift’ treatment.
Since the majority of hyaluronic acid fillers boast little to no complications, Belotero Balance may similarly have a low risk of severe complications, and may also be offered at a more competitive price point – only time will tell, and the United States may need to wait several months until the FDA completes the initial review process.