Evolence

Generic Name: dermal filler
Date of Approval: June 30, 2008
Company: OrthoNeutrogena

Treatment for: Facial Wrinkles

FDA Approves Evolence

The U.S. Food and Drug Administration has approved Evolence, a collagen-based structural dermal filler for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds.

Evolence represents a breakthrough in aesthetics. As one of nature's most fundamental and abundant building blocks, collagen comprises up to 80% of the dermis and it helps maintain skin strength, structure and support. Collagen naturally breaks down as a person ages, leading to the appearance of wrinkles, lines and folds.

Evolence, and its proprietary Glymatrix Technology, uses naturally sourced collagen to replace the body's lost collagen, adding volume and structural support in depleted areas, for a more naturally youthful appearance. In addition, no pre-test is needed, and Glymatrix Technology delivers longer-lasting durability than previous collagen dermal fillers.

Results are visible and immediate at the time of treatment, with minimal to no bruising or swelling, allowing physician and patient to gauge the amount of wrinkle correction with more precision. Evolence is recommended for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds, to be injected in the mid-to-deep dermis.

About Evolence

Evolence is an advanced collagen-based structural dermal filler that provides long-lasting treatment of moderate to deep facial wrinkles and folds, such as nasolabial folds. The results of treatment with Evolence are immediate, with little to no downtime post-treatment and clinically proven to last through six months. Additional data for 12-month duration approval is being filed with the FDA.

Unlike other dermal fillers that use hyaluronic acid (HA), which absorb water to create their effect, Evolence is a true structural agent due to its three-dimensional collagen matrix. This collagen structure benefits patients as it is directly linked to the minimal bruising and swelling that might result. Evolence does not use chemicals for cross-linking like many other products do, but instead uses natural sugar to improve durability. Evolence collagen is cross-linked through its patented Glymatrix Technology using the natural sugar, D-Ribose. The Glymatrix process is designed to:

· Mimic naturally occurring collagen in the skin by creating a true structural framework with natural, durable cross-links to ensure filler longevity

· Provide consistent and predictable results

· Use natural ingredients for natural-looking results

The naturally sourced porcine collagen used in Evolence is the most genetically similar to human collagen and has been used safely and effectively for decades in various medical applications, including heart valve replacement.

This new generation collagen filler is intended for injection into the mid-to-deep dermis for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds. The most common side effects of Evolence injections are usually injection-site related and include mild swelling, redness, and pain. Other rare side effects include the development of small areas of firmness under the skin at the treated sites that may be noticed when the areas are pressed upon.

Evolence has undergone rigorous testing and has been demonstrated to be safe and effective through clinical studies.

Evolence Information for Use

Description

Evolence Collagen Filler is a porcine collagen gel implant composed of 3.5% (35 mg/ml) homogenous Type I collagen that was extracted and purified from porcine tendons and suspended in phosphate-buffered saline (PBS) and which has been cross linked with a ribose mediated (GLYMATRIX) technology.

Evolence is supplied as single use pre-filled sterile syringe.

Indications for Use

Evolence Collagen Filler is an injectable product indicated for the correction of moderate to deep facial wrinkles and folds such as nasolabial folds.

Contraindications

Evolence Collagen Filler is contraindicated in the following:

· Patients with known hypersensitivity to any collagen products or planning to undergo desensitization injections to porcine products, as these injections can contain porcine collagen.

· Patients with a history of anaphylactic reactions or history or presence of severe recurrent allergic reactions.

· Evolence Collagen Filler should not be implanted in spaces other than the dermis of the face.

· Evolence Collagen Filler should not be implanted in patients with bleeding disorders.

Warnings

· Local necrosis is a rare event, which has been observed following other collagen implantation and may occur following injections to the glabella. It is thought to result from the injury, obstruction, or compromise of blood vessels.

· Patients with a history of dietary porcine allergy should be carefully examined before porcine collagen injections, since it is possible that the collagen component of the porcine material may be causing the allergy.

· Avoid injecting Evolence into blood vessels as collagen can initiate platelet aggregation and may cause vascular occlusion and localized infarction or embolic phenomena.

· Use of Evolence at specific sites in which infections or active inflammatory reaction is present, should be deferred until the underlined process has been controlled.

· Injection site reactions (e.g., swelling, redness, tenderness, or pain) to Evolence have been observed as consisting mainly of short-term minor or moderate inflammatory symptoms starting early after treatment and with less than 7 days duration. Refer to the adverse reactions section for details.

· Delayed onset inflammatory papules have been reported following the use of dermal fillers. Inflammatory papules (solid, raised skin lesions less than 1 cm in diameter) that may occur rarely should be considered and treated as a soft tissue infection.

Precautions

The following precautions must be observed:

· STERILE CONTENT. The prefilled syringe is intended for single patient use. Do not resterilize. Do not use if the package is opened or damaged.

· As with all transcutaneous procedures, injection of Evolence carries a risk of infection. The usual precautions associated with injectable material should be followed.

· Bruising or bleeding may occur at Evolence injection sites. Patients using substances, which may reduce coagulation, such as aspirin and nonsteroidal anti-inflammatory drugs, may experience increased bruising or bleeding at injection sites as experienced with any injection.

· The safety and effectiveness of Evolence for the treatment of anatomic regions other than facial wrinkles and nasolabial folds has not been established in controlled clinical studies.

· The safety and efficacy of Evolence for lip augmentation has not been established.

· The safety of usage in breast augmentation or injection into bone, tendon, ligament or muscle has not been established in controlled clinical studies.

· Evolence should be used with caution in patients on immunosuppressive therapy.

· The safety of Evolence in pregnant or breastfeeding females, as well as in patients under 18 years of age has not been established.

· The safety of Evolence with concomitant dermal therapies such as epilation, UV radiation, or laser, mechanical or chemical peeling procedures has not been evaluated in controlled clinical trials, therefore there are no data available on the potential for site inflammatory reaction.

· Injection of Evolence into patients with a history of previous herpetic eruption may be associated with reactivation of the herpes.

· Patients should minimize exposure of the treated areas to excessive sun, UV lamp exposure and extreme hot or cold weather for the first 24-48 hours following treatment.

· Based on preclinical studies the use of Evolence in individual patients shall be limited to 10 ml over a one year period. The safety of injecting greater amounts has not been established. In clinical trials using a split face design, patients were injected with up to approximately 4 mL of Evolence in a single injection site over a one year time period.

· The safety of Evolence in patients susceptible to keloid formation, hyperpigmentation and hypertrophic scarring has not been established.

· Long term safety and effectiveness of Evolence beyond one year have not been investigated in clinical trials.

· After use, treatment syringes and needles may be potential biohazards. Handle accordingly and dispose of in accordance with accepted medical practice and applicable local, state, and federal requirements.

· Evolence should not be mixed with other products before implantation of the device.

· Evolence is a yellowish, homogenous, opaque gel. In the event that a syringe contains material exhibiting separation between solid and liquid, or change of color, do not use the syringe and notify OrthoNeutrogena at 1-800-386-5362.

Adverse Events

The most common side effects of Evolence injections are usually injection-site related and include mild swelling, redness, and pain. Other rare side effects include the development of small areas of firmness under the skin at the treated sites that may be noticed when the areas are pressed upon.