Restylane

Generic name: non-animal stabilized hyaluronic acid (NASHA) injectable gel
Company: Medicis Aesthetics Inc.
Treatment for: Correction of Facial Wrinkles/Folds and Lip Augmentation

Medically reviewed by Drugs.com. Last updated on Mar 25, 2022.

What is Restylane?1

Restylane is a FDA-approved dermal filler made of a biodegradable, non-animal stabilized hyaluronic acid (NASHA). Hyaluronic acid is a natural substance found in all living organisms and provides volume and fullness to the skin.

Restylane is a gel of hyaluronic acid generated by Streptococcus species of bacteria. It is produced biotechnologically by natural fermentation in a sterile laboratory environment. This significantly diminishes the risk of transmitting diseases between species or of eliciting allergic reactions in patients who are sensitive to common foods, such as beef, chicken and eggs. Restylane does not require any allergy or skin test prior to injection.

Restylane is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane is also indicated for submucosal implantation for lip augmentation in patients over the age of 21.

Restylane is formulated as a clear gel and uses a dual mechanism of action to correct moderate to severe wrinkles and folds. Upon being injected beneath the skin's surface, Restylane gel integrates into dermal tissue then attracts and binds to water molecules to help maintain volume. Restylane is gradually degraded by the body's own mechanism and disappears without any residue. Results can be seen immediately following Restylane treatment and for up to six months. Some patients may achieve results that last longer than six months, depending upon injection site.

Restylane is a gel of hyaluronic acid generated by a Streptococcus species of bacteria. As opposed to other hyaluronic acid products, NASHA is not derived from animal sources. It is produced biotechnologically by natural fermentation in a sterile laboratory environment. This significantly diminishes the risk of transmitting diseases between species or of eliciting allergic reactions in patients who are sensitive to common foods, such as beef, chicken and eggs. Restylane does not require any allergy or skin test prior to injection.

Restylane is also marketed and sold in more than 65 countries outside the United States where it has been used in more than ten million procedures.

Restylane Clinical Trials¹

Six U.S. clinical trials were completed in support of the indications for Restylane. Four trials in over 500 patients evaluate safety and efficacy in mid-to-deep dermal implantation for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Two studies in roughly 200 patients were conducted in support of the indication of submucosal implantation for lip augmentation.

Restylane was shown to be effective when compared to cross-linked collagen and cross-linked hyaluronic acid dermal fillers with respect to the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and in lip augmentation.

Important Safety Information

Restylane is contraindicated:

• in patients with severe allergies, including allergies to gram positive bacterial proteins

• in patients with bleeding disorders
• for implantation in anatomical spaces other than the dermis or submucosal implantation for lip augmentation