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January 28, 2022

The FDA approves a new dermal filler to reduce the appearance of wrinkles

RHA Redensity, approved by the FDA last month, may be used to reduce moderate to severe wrinkles in adults aged 22 years or older.

By GlobalData Healthcare

Late last year on 22 December, the US Food and Drug Administration (FDA) announced the approval of RHA Redensity. Produced by Swiss hyaluronic acid product manufacturing company Teoxane, RHA Redensity is a gel implant or dermal filler that is injected in specific areas of facial tissue to reduce the appearance of lines and wrinkles. It consists of the chemical sodium hyaluronic acid (NaHA), 1,4-butanediol diglycidyl ether (BDDE) and 0.3% of the drug lidocaine hydrochloride to reduce pain on injection.

A doctor injects RHA Redensity into the dermis and superficial dermis for the correction of moderate to severe dynamic perioral rhytids. RHA Redensity may be used to reduce moderate to severe wrinkles around the mouths of adults aged 22 years and older.

RHA Redensity may help to reduce moderate to severe dynamic perioral rhytids for up to 12 months. In a clinical study, patients needed one or two treatments with multiple injections to achieve the best outcome. Specifically, 121 of the 150 subjects (80.7%) had a clinically meaningful improvement in their perioral wrinkles at the eight-week primary endpoint. Effectiveness was seen in 66.5% of subjects at 12 months.

Health authorities have widely discouraged elective procedures, including minimally invasive cosmetic procedures, during the Covid-19 pandemic to reduce the risk of infection and the burden on the healthcare system. As a result, more than 81% of aesthetic businesses in the UK had to close their clinics during the pandemic, while 67% of the businesses saw their revenues decline.

Dermal filler-related reactions reported in a clinical trial involving Moderna’s mRNA-1273 vaccine also raised concerns among people who were planning to get vaccinated. Three trial participants reported localised swelling in areas where they received dermal fillers. Although the reaction was termed as an immune response that caused inflammation, the incident led many people to reconsider cosmetic procedures.

Other factors such as widespread job losses and the inability to consult a doctor in-person also discouraged people from choosing cosmetic procedures. Because of this, with the current ongoing pandemic, the growth of the market in cosmetic injectables is not promising.

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