The role of injectable fillers in facial rejuvenation and volume restoration continues to grow. With their growing acceptance and the number of patients requesting such facial treatments, it is no surprise that new options for injectable fillers continue to emerge. The majority of these continue to be hyaluronic-based fillers because of their biocompatibility, ease of injection, and very low risk of complications.
Now adding to these hyaluronic-based fillers is Belotero. Earlier this week, Merz Aesthetics announced that the FDA has approved Belotero Balance for the correction of moderate-to-severe facial wrinkles and folds, specifically the nasolabial folds.Belotero is a hyaluronic acid-based gel that uses a cohesive polydensified matrix technology in its production. Its approval was based on results from a randomized, double-blind multicenter study of 118 patients. Based on these study results, the manufacturer claims that it has a lasting effect of 6 to 9 months and recommends two treatments per year to maintain the effects.
In a typical split-face design that all injectable filler prospects have used for FDA submission, the study patients received treatment with Belotero Balance filler on one side and a bovine collagen filler on the other side. Injections were into the nasolabial folds, the standard injection sites used for all FDA-approved injectable fillers. Patients were evaluated using a five-point Wrinkle Severity Scale (WSRS), ranging in severity from least (0) to most (4). Belotero Balance demonstrated greater reduction in the mean change of the WSRS at all time points and maintained more than 1 point WSRS reduction at 6 months (compared to 0.5 for the control).
Belotero has a significant prior history of use in Europe and the UK. Like many hyaluronic-based fillers today, it has different formulations intended for various types of facial uses. The Basic formulation (22.5mg/ml of NaHA) is intended for use in deep furrows, lip augmentation, facial outlines, nasolabial folds, glabellar lines and the correction of facial depressions. It is injected into the medium to deep dermis with a 27G needle. The Soft formulation (20mg/ml of NaHA) is used for superficial wrinkles such as perioral wrinkles, lip commissures, crow`s feet, and forehead wrinkles. It is injected into the upper dermis with a 30G needle. The Intense formulation (25.5mg/ml of NaHA) is for deeper lines and wrinkles. It is injected into the deep dermis with a 27G needle.
How does Belotero compare to the other hyaluronic-acid based fillers? It is impossible to say precisely but its composition and study results compare favorably to that of Juvederm. It is never a question of whether one type of injectable filler is better than another, it is a comparison of how long they last and their costs. The latter question with Belotero remains to be seen.
Dr. Barry Eppley
Indianapolis, Indiana