FDA approves "12 month" indication for Evolence

This week, the FDA approved a labelling change for the collagen-based filler Evolence, permitting what is known as a "12 month indication". In simple terms, this means the FDA was satisfied that the product has a significant effect on correcting moderate to deep facial wrinkles or nasolabial folds for 12 months. The original label indication was for six-month duration.

Evolence is the first collagen-based filler to get this "12 month indication", and you can bet that it will be featured extensively in future marketing.

What is not yet clear to me, however, is whether Evolence really performs significantly better than some of the other available filler agents (which currently have the older "6 month" label from the FDA) at 12 months after injection. There is data, for example, that Restylane also has significantly lasting effects well beyond their 6 month label.

I expect Allergan and Medicis (makers of Juvederm and Restylane respectively) will be submitting their data to the FDA, hoping for a similar 12-month approval, if only for competitive marketing purposes.