Restylane Kysse Lip Filler: Results, Cost and How Long It Lasts

Restylane Kysse is an injectable hyaluronic acid gel from Galderma's Restylane line, made for the lips.

The FDA approved it on March 26, 2020, under PMA P140029 S021 for two uses in patients over 21: lip augmentation and correction of upper perioral lines, the small vertical lines just above the upper lip.

Those two uses are what the approval order describes.

Using Kysse anywhere else is off-label, meaning the use is not on any current US label for the product.

The gel is bacterial-origin hyaluronic acid crosslinked with BDDE, at 20 mg/mL with 3 mg/mL (0.3%) lidocaine mixed in.

Like the Restylane and Juvéderm gels in our research, it is a crosslinked HA gel with lidocaine; what each maker does with that material is the subject of the comparison below.

On Galderma's own Restylane site, Kysse and Restylane Silk are the two products mapped to lips.

Silk came first: the FDA approved it in 2014 for submucosal lip augmentation and correction of perioral lines in patients over 21, and a small-bore blunt cannula for Silk lip augmentation followed in 2017.

The Restylane guide maps the rest of the family product by product, and the lip filler guide covers lip augmentation as a treatment — the consultation, aftercare and choosing an injector.

The clearest results data is the Kysse US pivotal trial, which randomized 273 subjects 2:1 against a control group.

Evaluators who did not know which subjects had been treated rated lip fullness on the Medicis Lip Fullness Scale; a responder was a subject with at least a 1-point improvement.

At week 8, 88% of evaluated subjects were responders — 155 of the 177 evaluated that week.

The responder rate then declined steadily across the trial's follow-up:

By the final time point in the data we reviewed, 60% of subjects were still responders — 101 of the 169 evaluated at week 48.

These are group results from one trial, not a prediction for any individual, and before-and-after photos in a practice's gallery show one patient's outcome, not yours.

The amounts used varied too.

The median total volume for initial treatment plus touch-up, all areas combined, was 2.50 mL — a median of 0.90 mL in the upper lip and 0.80 mL in the lower lip, plus 0.73 mL in the oral commissures (the corners of the mouth) and 0.20 mL in the perioral lines.

The label sets a recommended maximum of 6 mL per patient per treatment: 3 mL for the lips and 3 mL for the perioral area.

The medians are trial figures, not a standard dose, and the 6 mL figure is a label ceiling, not a target amount.

The first days also look different from the settled result.

In the trial's subject diaries, the most common lip reactions after initial treatment were swelling (90.2%), tenderness (87.4%) and bruising (85.8%), and most were tolerable and lasted less than 2 weeks.

The label expects injection-related reactions such as bruising, redness, itching, swelling, pain and tenderness to generally resolve on their own within one week.

A photo taken in that first week or two shows the swelling along with the filler.

The trial's published effectiveness results run to week 48, and the responder rate fell from 88% at week 8 to 60% at week 48 — the taper in the table above.

When subjects were re-treated, the median volume they received was 1.30 mL, against the 2.50 mL median for initial treatment plus touch-up.

That week-48 figure is the confirmed number behind the question "how long does Restylane Kysse last", and it is where the confirmed numbers end: we did not find a labeled duration figure for Kysse in the product data we reviewed, so we cannot endorse any month count you may have seen elsewhere.

The Kysse label's own description of the fade is that biodegradation varies by individual and treatment area, and that product remnants may remain in tissue even after the visible effect has returned to baseline.

Ask your provider how long they expect results to hold in your case and when they would suggest re-treating.

We could not confirm a published per-syringe price for Restylane Kysse, so the figure that matters is the quote you get from a practice.

The national reference point comes from the American Society of Plastic Surgeons (ASPS), whose latest statistics list an average cost of $743 for lip augmentation with dermal filler and $715 for hyaluronic acid fillers overall.

Those are average physician fees per procedure — typically one syringe — not med spa prices, and they will not tell you what an office near you charges.

Allergan tells Juvéderm patients that pricing varies by the Juvéderm product used, the amount of product used and the provider, and the amount clearly varies in Kysse's own data — the trial's median volume was 2.50 mL for initial treatment plus touch-up, against a label maximum of 6 mL per patient per treatment.

Ask what a quote includes: the amount of filler, the areas covered and whether touch-ups cost extra.

Galderma runs the ASPIRE Galderma Rewards program, which earns points on qualifying Galderma treatments, including Restylane.

If you book a Kysse treatment, ask whether the practice participates.

Both fillers are FDA-approved for the lips: Juvéderm Volbella XC in 2016 and Restylane Kysse in 2020, each for lip augmentation and perioral lines.

On duration, Allergan says Volbella lip results can last up to 1 year with optimal treatment, while Kysse's pivotal trial measured 60% of subjects still responders at week 48.

A maker's "up to" figure and a trial percentage are different kinds of numbers, and no head-to-head trial between the two appears in the product labels we reviewed — so neither can fairly be called better or longer-lasting.

Both are crosslinked hyaluronic acid gels with lidocaine mixed in; the composition described above is Kysse's, and we did not find a matching composition for Volbella in the product data we reviewed.

Allergan says several of its Juvéderm products use its VYCROSS blend of different HA molecular weights.

VYCROSS is Allergan's branded name for that blend — a technology story, not head-to-head evidence in either direction.

With no head-to-head data, the choice is one to make with a licensed injector, who can examine your lips, quote what each option costs in their hands and explain which they would use and why.

Bring the approval dates and the trial numbers above to the consultation.