Anti-ageing product sales to surge
from the US Food and Drug Administration (FDA). The product is made
with hyaluronic acid, a substance normally found in the skin that
helps keep it plump. Already used in Europe it helps smooth
wrinkles around the nose and mouth.
"Most people only need one injection of the gel to get optimal correction with about one-third of patients needing more to get a satisfactory result," said an FDA spokesperson.
Two other injectable products are already approved by the FDA for treating wrinkles. Collagen injections are used for correcting soft tissue deficiencies such as wrinkles and acne scars, and botulinum toxin is approved for treating frown lines between the eyebrows. Other treatments for wrinkles include topical creams, chemical peels and laser and electro-surgical resurfacing.
Botox Cosmetic is approved and marketed specifically for temporaryimprovement of frown lines in men and women aged 18 to 65. It's a natural,purified protein, which, in very low doses, relaxes the overactive musclesthat cause frown lines to form. The effects last about three to six months,after which lines gradually revert to their pre-treatment appearance.
Restylane is used to fill other wrinkles including those Collegan can already treat. "It's another option, they're both effective wrinkle fillers that can last up to six months in some cases," said FDA's Dr Celia Witten.
The FDA's approval of the injectable gel is based on a review of the clinical studies conducted by the manufacturer, Medicis Pharmaceutical (MRX) and on the recommendation of the General and Plastic Surgery Devices Panel of FDA's Medical Devices Advisory Committee.
In the pivotal study, conducted at six medical centres in the United States, 138 patients with naso-labial folds were injected with Restylane on one side of the face and Zyplast, a bovine collagen product, on the other side of the face.
The results showed that, six months after treatment, the effects of Restylane and Zyplast as wrinkle fillers were comparable.
As reported by patients within 14 days following the first treatment, the Restylane treated side had a lower incidence of severe redness (5.1 to 5.8 per cent) and an increased incidence of severe bruising (3.6 to 0.7 per cent), severe swelling (3.6 to 1.4 per cent), severe pain (3.6 to 1.4 per cent), and severe tenderness (2.9 to 1.4 per cent) compared with the Zyplast treated side. These incidents were lower with follow up injections for both products.
There was limited data in the study on the safety of Restylane in non-caucasians. The firm, Q-Med AB of Sweden, has supposedly agreed to conduct a post approval study in people of color to determine the product's safety for this population. The firm also claims it will provide training to physicians on the correct use of the device.
As the western economy shows signs of picking up, other cosmetic procedures such as breast augmentation, teeth whitening or straightening, and other dental and orthodontic procedures are also expected to be on the upswing.
These businesses have significant operating leverage, which means their profit margins are likely to rise faster than revenues because fixed costs don't change much as sales rise. Medicis Pharmaceutical (MRX) shares are already up 40 per cent this year alone.Indeed companies operating in the the anti-wrinkle sector are expected to see a rise in profits in 2004 as baby boomers continue to spend increasing amounts on anti-aging treatment.
