FDA Approves First Dermal Filler
The FDA has agreed to allow the first production an actual acne filler. In the United States, acne affects 40-50 million individuals.
The new drug is called Bellafill.
Suneva Medical Inc is the original creator of Bellafill. Bovine Collagen is credited for the results. The purpose of the drug is to raise collagen levels and lessen deep scars.
Bellafill will treat acne scars of faces of patients over 21 years old.
A cure for acne prone skin has long baffled drug developers.
FDA Approves First Ever Dermal Filler
And despite treatments such as topical gels and lasers, nothing has adequately treated scarring so far. Scarring affects up to 95 percent of acne sufferers.
The FDA OK’d the treatment in July. However, adopting this type of treatment comes with its high cost, related pain, and the need for repeat treatments.
A study testing Bellafill against placebo in 150 acne prone skin patients shows dramatic improvement in patients accepting Suneva’s treatment that lasts for up to a year.
Until now, they only had multiple laser treatments or injectables. However, they have potential side effects.
Bellafill gained approval in 2006 to smooth out people’s smile lines. Since then the demand for Bellafill has increased by 30 percent a year for several years in a row, Suneva CEO Nicholas Teti said in a meeting. It’s uses are for skin under your eyes, by your nose, lips, and laugh lines. It can also help with the appearance of acne scars. However, it is ultimately up to the users’ discretion as to where to inject the permanent filler.
The cost of the acne treatment is still under discussion, but will probably be similar to the wrinkle treatment at $2,500 for five syringes, Teti said.
Different dosages will depend on how severe the scarring is.
San Diego-based Suneva plans to begin Bellafill near the end of January.