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The US Food and Drug Administration (FDA) has approved Juvéderm Voluma XC(Allergan) to correct age-related volume deficits in the midface in adults aged 21 years and older, the company has announced.
Juvéderm Voluma XC is a gel composed of cross-linked hyaluronic acid suspended in phosphate-buffered saline with 0.3% lidocaine. It is the first dermal filler approved in the United States specifically for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the midface.
As reported by Medscape Medical News, the FDA’s General and Plastic Surgery Devices Panel unanimously agreed that Juvéderm Voluma XC is effective and safe and that the benefits outweigh the risks, according to the clinical trial data presented to the panel.
“As people age, the cheek area can lose volume, causing the cheeks to flatten out and the skin to droop and sag,” Derek H. Jones, MD, said in a company news release announcing the approval. Dr. Jones is associate professor of dermatology at the University of California, Los Angeles; founder and medical director of Skin Care and Laser Physicians of Beverly Hills; and clinical investigator in the Juvéderm Voluma XC pivotal study.
In the study, “physicians and patients were able to see instant and visible results, including correction of age-related volume loss in the cheek area and a more youthful appearance to the face,” Dr. Jones said.
JUVEDERM VOLUMA(TM) XC is made with Allergan’s proprietary VYCROSS(TM) technology, an advanced manufacturing process that results in a smooth gel that flows easily and consistently. This unique formulation contributes to the lift capacity to correct volume loss in the cheek area and to the duration of the product.(2,3) Additionally, JUVEDERM VOLUMA(TM) XC contains a small amount of lidocaine which helps to numb the treatment area during the injection procedure. The JUVEDERM VOLUMA(TM) formulation without lidocaine was first introduced in Europe in 2005. JUVEDERM VOLUMA(TM) with lidocaine was first introduced outside the U.S. in 2009. As of August 31, 2013, JUVEDERM VOLUMA(TM) with lidocaine (branded as JUVEDERM VOLUMA(TM) XC in the U.S.) is distributed in 72 countries, including markets in Europe, Latin America, Middle East, Asia Pacific, and Canada. The JUVEDERM(R) family of products, including JUVEDERM(R) Ultra and Ultra Plus, are marketed and sold in 85 countries outside the United States.(4)
The most common adverse effects observed in the clinical trial included temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. The adverse effects were predominantly moderate (uncomfortable) in severity and lasted 2 to 4 weeks.
Juvéderm Voluma XC will soon be available at Dr. Mark Bishara’s office. We will keep everyone updated when the product will be available in both of our Mansfield and Southlake offices.
This news is brought to you courtesy of Dr. Mark Bishara and The Paragon Plastic Surgery & Med Spa
As reported by Medscape Medical News, the FDA’s General and Plastic Surgery Devices Panel unanimously agreed that Juvéderm Voluma XC is effective and safe and that the benefits outweigh the risks, according to the clinical trial data presented to the panel.
“As people age, the cheek area can lose volume, causing the cheeks to flatten out and the skin to droop and sag,” Derek H. Jones, MD, said in a company news release announcing the approval. Dr. Jones is associate professor of dermatology at the University of California, Los Angeles; founder and medical director of Skin Care and Laser Physicians of Beverly Hills; and clinical investigator in the Juvéderm Voluma XC pivotal study.
In the study, “physicians and patients were able to see instant and visible results, including correction of age-related volume loss in the cheek area and a more youthful appearance to the face,” Dr. Jones said.
JUVEDERM VOLUMA(TM) XC is made with Allergan’s proprietary VYCROSS(TM) technology, an advanced manufacturing process that results in a smooth gel that flows easily and consistently. This unique formulation contributes to the lift capacity to correct volume loss in the cheek area and to the duration of the product.(2,3) Additionally, JUVEDERM VOLUMA(TM) XC contains a small amount of lidocaine which helps to numb the treatment area during the injection procedure. The JUVEDERM VOLUMA(TM) formulation without lidocaine was first introduced in Europe in 2005. JUVEDERM VOLUMA(TM) with lidocaine was first introduced outside the U.S. in 2009. As of August 31, 2013, JUVEDERM VOLUMA(TM) with lidocaine (branded as JUVEDERM VOLUMA(TM) XC in the U.S.) is distributed in 72 countries, including markets in Europe, Latin America, Middle East, Asia Pacific, and Canada. The JUVEDERM(R) family of products, including JUVEDERM(R) Ultra and Ultra Plus, are marketed and sold in 85 countries outside the United States.(4)
The most common adverse effects observed in the clinical trial included temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. The adverse effects were predominantly moderate (uncomfortable) in severity and lasted 2 to 4 weeks.
Juvéderm Voluma XC will soon be available at Dr. Mark Bishara’s office. We will keep everyone updated when the product will be available in both of our Mansfield and Southlake offices.
This news is brought to you courtesy of Dr. Mark Bishara and The Paragon Plastic Surgery & Med Spa
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
Cosmetic Surgeon Dr. Mark A. Bishara, M.D., serving Fort Worth, Arlington, and the surrounding area.
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