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The Food and Drug Administration has approved a new formulation of Restylane, known as Restylane Silk.
The new product was approved for submucosal lip augmentation and correction of perioral rhytids in patients aged 21 years and older. Restylane Silk is a clear, injectable gel composed of a non–animal-based formulation of hyaluronic acid, and it includes 0.3% lidocaine. The lidocaine was added to reduce the discomfort associated with the injectable, according to the manufacturer, Medicis, which is a division of Valeant Pharmaceuticals.
Restylane was first approved by the FDA in 2005 for mid-to-deep dermal implantation to treat moderate to severe facial wrinkles and nasolabial folds. An indication for submucosal lip augmentation was approved in 2011.
The Silk formulation is injected once or twice, as needed, over a 2-week period, and the effect lasts about 6 months, according to the FDA.
Restylane Silk is contraindicated in patients with a history of hypersensitivity or anaphylaxis, or a history of hypersensitivity to lidocaine, or gram-positive bacteria such as Streptococcus. It should not be used in patients with a bleeding disorder.
Safety and effectiveness were gauged in a 221-patient study. Restylane Silk was evaluated in patients with light and dark skin; 52 patients had Fitzpatrick skin types IV and V. The incidence of adverse events in these 52 patients was similar to that in the overall study population, but the safety in patients with Fitzpatrick skin type VI has not been established, said the FDA.
Side effects include bruising, redness, swelling, pain, tenderness, and itching. There were 12 severe events in six study patients; 10 were lip swelling. There were five serious adverse events in three patients.
Valeant said that 98% of study patients reported improvement in their lip fullness 14 days after injection, and 76% still had lip improvement after 6 months.
On Twitter @aliciaault
The Food and Drug Administration has approved a new formulation of Restylane, known as Restylane Silk.
The new product was approved for submucosal lip augmentation and correction of perioral rhytids in patients aged 21 years and older. Restylane Silk is a clear, injectable gel composed of a non–animal-based formulation of hyaluronic acid, and it includes 0.3% lidocaine. The lidocaine was added to reduce the discomfort associated with the injectable, according to the manufacturer, Medicis, which is a division of Valeant Pharmaceuticals.
Restylane was first approved by the FDA in 2005 for mid-to-deep dermal implantation to treat moderate to severe facial wrinkles and nasolabial folds. An indication for submucosal lip augmentation was approved in 2011.
The Silk formulation is injected once or twice, as needed, over a 2-week period, and the effect lasts about 6 months, according to the FDA.
Restylane Silk is contraindicated in patients with a history of hypersensitivity or anaphylaxis, or a history of hypersensitivity to lidocaine, or gram-positive bacteria such as Streptococcus. It should not be used in patients with a bleeding disorder.
Safety and effectiveness were gauged in a 221-patient study. Restylane Silk was evaluated in patients with light and dark skin; 52 patients had Fitzpatrick skin types IV and V. The incidence of adverse events in these 52 patients was similar to that in the overall study population, but the safety in patients with Fitzpatrick skin type VI has not been established, said the FDA.
Side effects include bruising, redness, swelling, pain, tenderness, and itching. There were 12 severe events in six study patients; 10 were lip swelling. There were five serious adverse events in three patients.
Valeant said that 98% of study patients reported improvement in their lip fullness 14 days after injection, and 76% still had lip improvement after 6 months.
On Twitter @aliciaault
The Food and Drug Administration has approved a new formulation of Restylane, known as Restylane Silk.
The new product was approved for submucosal lip augmentation and correction of perioral rhytids in patients aged 21 years and older. Restylane Silk is a clear, injectable gel composed of a non–animal-based formulation of hyaluronic acid, and it includes 0.3% lidocaine. The lidocaine was added to reduce the discomfort associated with the injectable, according to the manufacturer, Medicis, which is a division of Valeant Pharmaceuticals.
Restylane was first approved by the FDA in 2005 for mid-to-deep dermal implantation to treat moderate to severe facial wrinkles and nasolabial folds. An indication for submucosal lip augmentation was approved in 2011.
The Silk formulation is injected once or twice, as needed, over a 2-week period, and the effect lasts about 6 months, according to the FDA.
Restylane Silk is contraindicated in patients with a history of hypersensitivity or anaphylaxis, or a history of hypersensitivity to lidocaine, or gram-positive bacteria such as Streptococcus. It should not be used in patients with a bleeding disorder.
Safety and effectiveness were gauged in a 221-patient study. Restylane Silk was evaluated in patients with light and dark skin; 52 patients had Fitzpatrick skin types IV and V. The incidence of adverse events in these 52 patients was similar to that in the overall study population, but the safety in patients with Fitzpatrick skin type VI has not been established, said the FDA.
Side effects include bruising, redness, swelling, pain, tenderness, and itching. There were 12 severe events in six study patients; 10 were lip swelling. There were five serious adverse events in three patients.
Valeant said that 98% of study patients reported improvement in their lip fullness 14 days after injection, and 76% still had lip improvement after 6 months.
On Twitter @aliciaault
