FDA Approves BELOTERO VOLUME (+) and BELOTERO INTENSE (+)

The US Food and Drug Administration (FDA) has approved BELOTERO VOLUME (+) and BELOTERO INTENSE (+), expanding Merz Aesthetics’ BELOTERO portfolio of hyaluronic acid (HA) injectable treatments in the United States.

BELOTERO VOLUME (+) is designed to restore volume and contour in the cheeks and midface to address age-related volume loss. BELOTERO INTENSE (+) is designed for lip augmentation, temporarily adding volume and improving lip fullness while supporting movement in the treatment area.

The two products join BELOTERO BALANCE (+), which received FDA clearance in 2021 for smoothing moderate to severe facial wrinkles and folds, according to information provided by the company.

BELOTERO Portfolio Expands to Midface and Lip Augmentation

BELOTERO products use Merz Aesthetics’ Cohesive Polydensified Matrix (CPM) gel technology, which the company describes as combining high- and low-density zones intended to mimic characteristics and behavior of tissue and support integration following injection.

Clinical data cited by Merz Aesthetics showed 95% patient satisfaction through 18 months with BELOTERO VOLUME (+). For BELOTERO INTENSE (+), the company reported 100% patient satisfaction at 8 weeks, with volume maintained through 12 months.

The approvals broaden the company’s US HA filler offerings across facial balancing, midface volume restoration, and lip enhancement. Merz Aesthetics cited market research indicating that lips and cheeks remain frequently requested aesthetic treatment areas and that 74% of surveyed patients prefer treatments intended to enhance rather than transform their appearance.