Acne is the most common skin disorder in the United States, affecting up to 50 million people, according to the American Academy of Dermatology. It’s so widespread that by their mid-teens, more than 40 percent of adolescents have acne or acne scarring, the Washington, D.C.-based nonprofit says.
Local aesthetic medical device company Suneva Medical Inc. is on the verge of launching a phase 3 study for a dermal filler that could be the first approved by the Food and Drug Administration for the treatment of acne scars.
“This is an unmet medical need,” said Nicholas Teti, Suneva chairman and CEO. “There’s no permanent solution for acne scars on the market today.”
Suneva’s product, Artefill, is an injectable filler that gained FDA approval for treating “smile line” facial wrinkles. Canadian regulators cleared the product under the name Bellafill.
Unlike products such as Botox that are absorbed into the body after several months, Artefill is a “permanent” filler, lasting five years or more. It contains collagen and very small plastic beads, Teti said.
To date, more than 30,000 patients have been treated with Artefill, said Teti, who served as president and CEO of DuPont Pharmaceuticals earlier in his career.
Suneva in February will begin enrolling 150 patients with acne scars for its placebo-controlled study. It’s a larger trial than is customary for dermal fillers, Teti said, but the goal is to come out with compelling scientific data that will set it apart from competing products.
“There’s dermabrasion, lasers and other fillers out there, but some things only work on a temporary basis — and nothing has been tested scientifically,” he said.
The 50-person company hopes to have its study done by the first or second quarter of 2013 and hopes to submit the product for FDA review later that year. If approved, Artefill will give Suneva’s salespeople an edge when marketing the product to physicians, Teti said.
Americans spent nearly $10.7 billion on cosmetic procedures in 2010, according to the latest figures reported from the American Society for Aesthetic Plastic Surgery, a trade group based in New York. Of that total, $1.9 billion was spent on injectables.
Privately held Suneva, located in Sorrento Valley, is backed by venture capital company Cowen Healthcare Royalty Partners, L.P.
Suneva was formed in 2009 to manufacture and sell Artefill after Artes Medical Inc. — the company that launched the product — went out of business. Artes Medical reported 2007 product sales of $7.1 million. Teti said that Suneva has exceeded those sales.