From the Wires
BELOTERO BALANCE® Dermal Filler Is Now Available Nationwide
Hyaluronic Acid (HA) Based Dermal-Filler Provides Soft, Natural-Looking, Long-Lasting Results in a Safe and Quick Procedure
By: PR Newswire
Nov. 6, 2012 08:01 AM
GREENSBORO, N.C., Nov. 6, 2012 /PRNewswire/ -- Merz, Inc. through its aesthetics division, Merz Aesthetics, Inc., today announced the nationwide availability of BELOTERO BALANCE® Dermal Filler, a natural-looking, long-lasting dermal filler that was approved by the Food and Drug Administration (FDA) in November 2011 as a safe solution for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds, or smile lines around the mouth. This dermal filler joins the Merz Aesthetics portfolio of injectable products, including RADIESSE® Volumizing Filler and Asclera® (polidocanol) Injection.
"We believe that BELOTERO BALANCE® Dermal Filler has a unique place in the aesthetic market as a competitive and effective choice that provides physicians with a new option for ensuring meaningful results for patients seeking to treat the appearance of both wrinkles and folds," said Dennis Condon, president of Merz Aesthetics, Inc. "We look forward to the availability of BELOTERO BALANCE® Dermal Filler as we continue our company's legacy of providing the field of aesthetic dermatology with unparalleled service and a wide range of safe and effective products."
BELOTERO BALANCE® Dermal Filler complements Merz Aesthetics' well-established product portfolio of injectable products by utilizing a technology that allows the material to naturally adapt within the skin in order to provide smooth and even correction with lasting results. The launch of BELOTERO BALANCE® Dermal Filler represents the company's commitment to providing physicians and patients with innovative treatment options in aesthetic dermatology.
BELOTERO BALANCE® Dermal Filler was approved by the FDA based on the results from a randomized, double-blind, active-controlled, multicenter study of 118 patients. In a split-face design, patients received bilateral treatment with BELOTERO BALANCE® Dermal Filler and an approved bovine collagen (COL) filler for the correction of their moderate-to-severe nasolabial folds (NLFs). Patients were evaluated using a five-point Wrinkle Severity Rating Scale (WSRS), ranging in severity from least zero (0) to most four (4). Treatment with BELOTERO BALANCE® Dermal Filler resulted in a decrease in the severity of NLFs from baseline.
To find a physician who can administer treatments, or to learn more about BELOTERO BALANCE® Dermal Filler, please visit www.BELOTERO.com.
Please see Important Safety Information for BELOTERO BALANCE® Dermal Filler below.
About Merz, Inc.
Merz, Inc. is a focused specialty healthcare company that is responsible for developing and commercializing innovative products and solutions in neurology, medical aesthetics, and dermatology in the U.S. For more than 100 years, the development of our products has been based on our commitment to innovative medical approaches that earn trust among patients, physicians, customers and partners worldwide. Our ambition is to become a recognized leader in the treatment of movement disorders, as well as aesthetic and dermatologic conditions. Our pipeline is promising, and with new therapeutic options we will continue our commitment to improving patients' lives.
About Merz Pharma Group
Globally, the companies of Merz Pharma Group are focused on medications for treating neurological and psychiatric illnesses and thereby assume a leading role in the field of Alzheimer's disease research. Another important area of competency of Merz Pharma Group is Clinical Dermatology and Aesthetic Medicine. Merz Pharma Group is also active in the Health sector outside of the pharmacy. In the field of consumer products Merz Consumer Care is a leading provider of products for self-medication, nutritional supplements, and skin care. Merz Pharma Group is a privately owned company, founded in 1908 in Frankfurt, Germany.
Important Safety Information for BELOTERO BALANCE® Dermal Filler
Indication: BELOTERO BALANCE® is FDA-approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.
Contraindications: BELOTERO BALANCE® should not be used in patients with severe allergies manifested by a history of anaphylaxis, with a history or presence of multiple severe allergies. BELOTERO BALANCE® contains a trace amount of gram-positive bacterial proteins, and is contraindicated in patients with a history of allergies to such material. BELOTERO BALANCE® must not be implanted into blood vessels.
Warnings: Use of BELOTERO BALANCE® at specific sites in which an active inflammatory process (skin eruptions such as cold sores, cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled. BELOTERO BALANCE® must not be injected into blood vessels of any size. Introduction of BELOTERO BALANCE® into the vasculature may occlude the vessels and can cause infarction of overlying tissue or embolization with resultant necrosis of potentially large areas of distant tissue such as the lip or the nose. Injection site responses to BELOTERO BALANCE® have been observed, consisting mainly of short-term inflammatory symptoms starting early after treatment and with 7 days duration or less.
Precautions: The safety or effectiveness of BELOTERO BALANCE® for the treatment of dermal contour defects other than nasolabial folds, such as use in the lips, has not been established in controlled clinical studies. The safety of BELOTERO BALANCE® for use during pregnancy, in breastfeeding females, or in patients under 21 years has not been established. As with all transcutaneous procedures, BELOTERO BALANCE® injection carries a risk of infection. Patients who are using substances that reduce coagulation, such as aspirin, non-steroidal anti-inflammatory drugs and warfarin may, as with any injection, experience increased bruising or bleeding at injection sites. Patients should inform their physicians if they are taking such substances. Exposure of the treated area to excessive sun, UV lamp exposure and extreme cold weather should be minimized until any initial swelling and redness have resolved and puncture sites have healed.
Adverse Events: The most common side effects seen after injection were swelling, bruising, redness and hardening that resolve within one week. More rare side effects may include swelling that lasts longer, unevenness or firmness in the area injected, and as with any injection, there may be a risk of infection.
Important: For full safety information, please visit www.Belotero.com or call Merz Aesthetics Customer Service at 866-862-1211
Caution: Rx Only
SOURCE Merz, Inc.
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