Mark A. Bishara, MD

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FDA Approves New Juvéderm Voluma XC For Adult Midface Volume Loss

By http://www.markbisharamd.com/author/
November 4, 2013

New from JUVÉDERM® – JUVÉDERM® VOLUMA™

The Food and Drug Administration has approved the cosmetic filler Juvéderm Voluma XC (hyaluronic acid/HA, Allergan).

The HA filler is the first and only filler to be approved for the temporary correction of age-related volume loss in adult patients ages 21 and older, according to a news release. The product is expected very soon, Allergan states.

Juvéderm Voluma XC, uses Allergan’s Vycross technology that results in a smooth gel. It also contains lidocaine to help numb the area during an injection procedure, the company states.

The new Juvederm Voluma XC has a long life, it has reversibility, and it is a product that really is geared to robustly treat the cheek in an efficient way.

The filler is designed to lift. What makes it different is that it uses a lower molecular weight hyaluronic acid that allows for increased cross-linking that gives the product an ideal lift capacity for the midface.

The approval follows the results of a single blinded controlled clinical trial conducted at 15 U.S. and two Canadian sites, which demonstrated efficacy and safety.

Results demonstrated that almost 50 percent of patients were maintaining optimal correction at two years. Similarly, patients demonstrated clinically significant results after almost three years.

Patients received touch-up treatment after 30 days as necessary and were followed up at one month, three months and then quarterly for up to two years, according to the study. Response was determined by two blinded investigators’ assessments at six months based on whether the patient had improved by one point or more on a validated six-month Mid-Face Volume Deficit Scale (MFVDS).

Dermatologists and plastic surgeons are going to be most concerned about patient satisfaction. 90 percent of patients reported feeling that they appeared, on average, five years younger at six months based on analysis of patient diaries. As far out as two years, patient satisfaction was at 76 percent.

The most common adverse effects seen during the clinical trial were injection site tenderness, bruising, redness, discoloration, swelling, lumps/bumps, firmness, itching, and pain that lasted approximately two to four weeks.

This news is brought to you courtesy of Dr. Mark Bishara and The Paragon Med Spa (817) 473-2120



 

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