Evolence

Evolence

Generic Name: dermal filler

Date of Approval: June 27, 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.

Evolence Side Effects

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.

Directions 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.

Assembly of Needle to Syringe:

For safe use of Evolence it is important that the needle is properly assembled onto the syringe. Use the 27GX1/2� needle provided.

Carefully unscrew the syringe tip cap while securely holding the syringe Luer adapter.

With a loose grip on the narrow part of the needle shield, mount the needle on the Luer-syringe lock by screwing clockwise until counter pressure is felt.

With a firm grip on the wider part of the needle shield, press and turn the needle further until secure (approximately a quarter turn).

Remove the needle shield by pulling the shield straight away from the syringe, ensuring not to twist the shield during removal.

Injection of Evolence Collagen Filler:

Prior to treatment with Evolence the patient should be fully apprised of the indications, contraindications, warnings, precautions, adverse events and method of administration. A complete medical history should be obtained to ensure suitability for treatment. Patient also should be advised that a supplemental "touch-up" injection may be required to achieve and maintain optimal correction.

The patient's wrinkle or fold should be characterized with regard to etiology, distention, stress at site and depth of lesion. Pretreatment photographs are recommended.

Topical and/or injectable anesthesia may be used to manage pain during and after injection.

After ensuring that the patient has thoroughly washed the treatment area with soap and water, the area should be swabbed with alcohol or another antiseptic substance.

Before injecting the patient, depress the plunger until the product flows out of the needle.

The needle should be placed in a sterile manner into the plane(s) of apparent deformity.

The injection technique of Evolence with regard to the angle and orientation of the bevel, the depth of injection and the quantity administered may vary. A linear threading technique, tunneling technique, serial puncture injections or combinations have been used to achieve optimal results.

For linear threading technique and/or tunneling technique the needle is inserted at an approximate angle of 300 parallel to the length of the wrinkle or fold. The bevel of the needle should face upward and the substance should be injected into the mid to deep dermis. This can be ascertained by observing a subtle elevation of the defect without any blanching following injection.

If Evolence is injected too superficially this may result in visible lumps and or discoloration.

Inject Evolence by applying even pressure on the plunger rod while slowly pulling the needle backwards. The wrinkle should be lifted and eliminated by the end of the injection. It is important that the injection is stopped just before the needle is pulled out of the skin to prevent material from leaking out or ending up too superficially in the skin.

Correct to 100% of the desired contour effect. Do not overcorrect. With cutaneous contour deformities the best results are obtained if the defects can be manually stretched to the point where it is eliminated. The degree and duration of the correction depend on the character of the defect treated, the tissue stress at the injected site, the depth of the implant in the tissue and the injection technique.

If immediate blanching occurs, this could be an indication that the device injection is too superficial. The injection should be stopped and the area massaged until it returns to a normal color. When the injector continues treatment, they should assure that the appropriate injection depth is reached.

When injection is complete, the treated side should be gently massaged so it conforms to the contour of the surrounding tissues. In the event of unintentional overcorrection, massage the area firmly between your fingers or against an underlying superficial bone to obtain optimal results.

Needles may become occluded or dull during a treatment session, and needle replacement may be necessary.

With patients who have localized swelling, the degree of correction is sometime difficult to judge at the time of treatment. In this case it is better to invite the patient to a touch-up session after 1-2 weeks. Although the company has not observed severe reactions during treatment in the 668 subjects injected in the US Evolence clinical trials, in the event that severe swelling or a systemic reaction occurs during injection, discontinue treatment and contact OrthoNeutrogena (1-800- 386-5362).

Corrective touch up injection may be required to achieve optimal correction of the contour. If the deformity needs further treatment the same procedure should be repeated until a satisfactory result is obtained. The need for an additional treatment may vary from patient to patient and is dependent upon a variety of factors such as deformity severity, skin elasticity and dermal thickness at the treatment site.

Patients may have mild to moderate injection site reactions, which typically resolved in a few days.

Severely indurated defects which initially resist distention may require several treatment sessions before desired correction is obtained. In such defects, it is preferable to fill within the indurated defect rather than beneath it.

The physician should instruct the patient to report any problems possibly associated with the use of Evolence.

Patient Instructions

It is recommended that the following information be shared with patients:

Within the first 24-48 hours patients should avoid :

Strenuous exercise

Excessive sun, extreme heat, or extreme cold exposure

Alcoholic beverages

Exposure to any of the above may cause temporary redness, swelling and/or itching at the injection sites.

To report an adverse reaction, call OrthoNeutrogena (1-800- 386-5362).

For more information, please visit www.evolence.com.