US regulators have issued a green light for Suneva Medical’s Bellafill as the first dermal filler to treat scars left by acne, the most common skin condition in the country.
Acne affects 40-50 million people in the US and up to 95% may go on to develop scarring but are left with limited treatment options, highlighting the significant potential market and unmet medical need.
The US Food and Drug Administration has declared Bellafill safe and effective for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.
"In the dermatology field, we regularly see patients who live with the burden of acne scarring - a physical and emotional burden that leads many to feel depressed, less energetic and less social,” said Ava Shamban, Assistant Clinical Professor of Dermatology at UCLA, and an investigator in the study. “With Bellafill, we have a tremendous opportunity to remedy acne scars and help patients live a happier, healthy life”.
Bellafill is 80% purified bovine collagen and 20% polymethylmethacrylate microspheres, and basically works by adding volume to the skin to lift and smooth out pitted acne scars to the level of the surrounding areas.
The filler has been on the market for wrinkles since 2006, and for acne pricing is likely to be similar at around $2,500 for five syringes, Suneva chief executive Nicholas Teti said in an interview reported by Reuters.