Starting in the Middle

New products and evolving techniques have put midface filling front and center for noninvasive facial rejuvenation.
Fillers for midface rejuvenation

The middle third of the face extends from the infraorbital rim to the upper lip and includes the zygomatic arch and maxilla. Age-related volume loss in this area is influenced by genetics, general health and dentition—among other factors—resulting in sagging fat pads, deepening nasolabial folds, and a host of hollows and wrinkles. Until the turn of the 21st century the only way to correct these problems was plastic surgery, a solution available to only a few.

Results From Phase 4 Clinical Studies of Restylane Refyne and Restylane Defyne Released

Phase 4 Clinical Study Results on Restylane Refyne and Defyne

Galderma has released the results from two Phase 4 clinical studies of Restylane Refyne and Restylane Defyne, the most recent U.S. additions to it Restylane family of soft tissue fillers. The Natural Expression study found that natural facial expression was maintained in 95% (60/63) of subjects (primary objective). The Dynamic Strain study found that 83% (25/30) of subjects had enhanced attractiveness, looked younger and maintained expression following injections of Restylane Refyne and Restylane Defyne.

FDA Approves Restylane Refyne and Restylane Defyne Dermal Fillers

FDA Approves Restylane Refyne and Restylane Defyne Dermal Fillers

Galderma has received U.S. Food and Drug Administration (FDA) approval of two new Restylane products for the treatment of nasolabial folds (NLF) in patients over the age of 21. Restylane Refyne is approved for the treatment of moderate to severe facial wrinkles and folds, and Restylane Defyne for the treatment of moderate to severe, deep facial wrinkles and folds.

Restylane Turns 20

Galderma is celebrating 20 years of Restylane with new packaging and a new, more ergonomic syringe design.
Restylane Turns 20

Though silicone- and then collagen-based dermal fillers have been used since the 1940s to fill out facial defects, it was the introduction of hyaluronic acid (HA)-based dermal fillers that brought these treatments to the main­­stream. “HA fillers completely changed cosmetic medicine,” says facial plastic surgeon Steven Dayan, MD, clin­ical assistant professor at the University of Illinois. “They don’t just fill lines; they actually give volume back to the face. They also have a more natural feel than collagen and offer reversibility that is reliable.

Galderma Initiates Two Phase 3 Restylane Trials

Galderma has announced that it will be launching two pivotal Phase 3 trials focused on its Restylane dermal fillers.

The Restylane Silk Cannula Study is a multicenter trial that will evaluate the safety and tolerability of Restylane Silk when delivered via microcannula.

The Restylane Lyft Hand Rejuvenation Study is a randomized, controlled, multicenter study to assess the safety, tolerability and efficacy of Restylane Lyft for volume loss in the hands.

Restylane Becomes First Approved Lip Filler

Restylane Receives FDA Approval for Lip Augmentation

The United States Food and Drug Administration has expanded the approved usage of RESTYLANE Injectable Gel (Medicis Aesthetics) to include lip augmentation. RESTYLANE was previously approved to treat moderate to severe facial wrinkles and nasolabial folds. Its new label will include an indication for submucosal implantation for lip augmentation in patients over the age of 21. In addition, the RESTYLANE package insert will be amended to include both the new indication and results from the clinical trials for lip augmentation.