Developed and marketed by US-based Fibrocell Sience, the product was granted a Biologics License Application and is based on a process that extracts and multiplies an individual’s own fibroblast skin cells to create an injectable treatment that is said to target the appearance of facial lines and wrinkles.
Targeting severe nasolabial wrinkles, the treatment is well tolerated by users in clinic trials that took place in the US, with the majority of adverse events being mild to moderate and resolved within the space of one week, the makers claim.
Common side affects are bruising, bleeding, swelling, and acute sensitivey around the area where the injections are carried out.
Fibroblasts help produce essential collagen
In undamaged or younger skin, renewal of fibroblasts helps to produce collagen, the structure that helps to support the skin, keeping it firm and wrinkle-free when it is in plentiful supply.
The fibrolbasts are removed from an area of skin behind the patient’s ear and then cultured for 90 days, to produce millions of new cells that can be injected back into the patient over the course of two or three separate treatments.
The FDA-approval was given on the basis of clinical trials that combined the results of two identical Phase III multi-centre, randomized, double-blind placebo-controlled studies involving a total of 421 patients.
Trials demonstrate efficacy of treatment
The trials found that the treatment effectively improved the appearance of nasolabial fold wrinkles for six months, while the company says that further trials will have to be conducted to determine exactly how long the treatment may last for.
Like Botox, the laViv treatment is injected into areas of the skin where wrinkles and fine lines occur, namely around the eyes, mouth and smile lines along the nose.
“The concept of using a patient’s own collagen-making cells is a revolutionary way to help treat nasolabial fold wrinkles and help restore a fresh appearance,” said Dr. Robert Weiss, clinical associate professor at John Hopkins School of Medicine, where some of the clinical trials on the treatment took place.
“Since this is a biological process that works over time, laViv is able to provide gradual and natural-looking results.”
Claimed to last longer than Botox
Indeed, the treatment is said to be longer-lasting than its big rival Botox, which leads industry experts to believe that it could prove big competition.
However, the treatment is likely to cost significantly more than Botox, given the fact that the procedure to produce it is more complex and labour intensive.
The procedure is expected to be launched in selective metropolitan areas throughout the US as manufacturing capacity is increased and physicians are trained up on how to carry out the procedure, before being launched internationally.