The U.S. Food and Drug Administration approved the first dermal filler to treat scarring caused by acne, the most common skin disorder in the United States afflicting 40-50 million people.
Bellafill, developed by privately held Suneva Medical Inc,
is made primarily of bovine collagen. When injected, it lifts and smoothens pitted scars to the level of the surrounding skin.
It is designed to treat moderate to severe acne scars on the cheeks of patients over the age of 21, Suneva said on Tuesday.
A cure for acne has long eluded drug developers.
And despite treatments ranging from topical gels to lasers, nothing so far has satisfactorily treated scarring that affects up to 95 percent of acne sufferers.
The FDA cleared a laser treatment for acne scarring in July, but adoption for this kind of therapy is limited by its high cost, associated pain and the need for repeat treatments.
A study testing Bellafill against a placebo in 150 acne patients showed a significant improvement in patients receiving Suneva's treatment that continued for up to a year.
"Until now, multiple laser treatments or other injectables have been used but are limited both in terms of efficacy and longevity and are hampered by potential side effects," Dr. Ava Shamban, an assistant clinical professor of dermatology at UCLA, who was involved in the Bellafill study, told Reuters.
Approved in 2006 to smoothen "smile lines", demand for Bellafill has grown more that 30 percent a year for the last several years, Suneva CEO Nicholas Teti said in an interview.
Pricing of the acne treatment is still being worked out but is likely to be similar to that of the wrinkle treatment at $2,500 for five syringes, Teti said.
Dosages would depend on the severity of the scarring.
San Diego-based Suneva plans to launch Bellafill toward the end of January.