Restylane: Every Product in the Range, and What Their FDA Trials Actually Compared Against
Reviewed for medical accuracy against our Medical Review Board · Last updated 2 September 2026
Part of Dermal Fillers
Restylane is not a product. It is a range of eight, approved under two separate FDA applications across twenty years, for jobs as different as plumping a lip and filling the hollow under an eye. Which one you are offered matters more than the brand on the box.
We read the three FDA trial documents behind the newest members of the range. They contain something no consumer page about Restylane mentions: the trials were not built the same way, and in two of them the product the range was measured against did better on the raw numbers than the Restylane product did.
Three things worth knowing first. One, the range spans two FDA applications and the products are not interchangeable: each is approved for a specific area and depth. Two, the success rates you will see quoted cannot be compared, because these trials used three different kinds of control group. Three, in the Refyne and Defyne studies the comparison filler scored higher than the Restylane product at every timepoint. That is not a failure, and the reason why is worth understanding.
Every product in the range, and what each is approved for
Two FDA applications are live. P040024, originally approved in 2005, carries the classic line plus Lyft and Eyelight. P140029, from 2016, carries Refyne, Defyne, Kysse and Contour. The approval wording below is the actual indication, not the marketing.
| Product | FDA approval | Approved | Approved for |
|---|---|---|---|
| Restylane Silk | P040024/S072 | 13 June 2014 | Submucosal implantation for lip augmentation, and dermal implantation for correction of perioral rhytids, over 21 |
| Restylane Lyft | P040024/S073 | 1 July 2015 | Deep dermis to superficial subcutis for moderate to severe facial folds and wrinkles such as nasolabial folds, and subcutaneous to supraperiosteal for cheek augmentation and age-related midface contour deficiencies, over 21. A 2018 supplement added the dorsal hand, to correct volume deficit, and a November 2025 supplement added the chin |
| Restylane Refyne | P140029 original | 9 December 2016 | Mid to deep dermis, moderate to severe facial wrinkles and folds such as nasolabial folds, over 21 |
| Restylane Defyne | P140029 original | 9 December 2016 | Mid to deep dermis, moderate to severe deep facial wrinkles and folds, over 21. A 2021 supplement added chin augmentation for mild to moderate retrusion |
| Restylane Kysse | P140029/S021 | 26 March 2020 | Injection into the lips for lip augmentation and correction of upper perioral rhytids, over 21 |
| Restylane Contour | P140029/S032 | 28 June 2021 | Cheek augmentation and correction of midface contour deficiencies, over 21 |
| Restylane Eyelight | P040024/S135 | 2023 | Improvement of infraorbital hollowing, meaning the hollow under the eye, over 21 |
Note how much overlap there is, and how much it matters. Silk and Kysse are both lip products. Lyft and Contour both do cheeks and midface. Refyne and Defyne both do nasolabial folds, and the only difference in the approval wording is the word "deep" in Defyne's. Two products in this range are approved for the chin, and only one of those two is approved for hands.
Restylane, Restylane-L and Perlane are the older members of the line. The "-L" suffix means the same gel with lidocaine added, which is an anaesthetic, not a different filler.
Perlane is worth a note because the name persists. It is widely described online as having simply become Lyft, but the FDA record does not support that tidily: Perlane and Restylane Lyft appear together in the same filing from August 2015, and Perlane is still named in filings as late as December 2021. So if a clinic quotes you "Perlane", do not assume you know which product is coming. Ask which current product they mean and which approval covers your area.
The three different control groups, and why they matter
Every trial needs something to compare against. What a trial chooses says a lot about what question it was actually asking, and the Restylane range chose three different answers.
| Product | Compared against | Question the trial asked |
|---|---|---|
| Kysse | Another approved filler, 184 vs 89 | Is it not worse than an existing product |
| Refyne and Defyne | An approved HA filler with similar characteristics | Is it not worse than an existing product |
| Eyelight | No treatment, 287 vs 46 | Does it beat doing nothing |
These are not the same question, and the second is much easier to pass than it sounds while the first is a different test entirely. A non-inferiority trial, which is what Kysse, Refyne and Defyne ran, never asks whether the product beats leaving your face alone. It asks whether it falls short of an existing filler by more than an agreed margin. Pass that and you are approved, without anyone having established how much of the result was the product.
Compare that with Radiesse and Juvederm Volux, whose jawline trials used untreated control groups. Those trials produced an uncomfortable and useful number: on our jawline filler page, 39.1% of people who received nothing at all were scored as improved by a blinded evaluator. Restylane's non-inferiority trials never generated that number, so nobody knows what it would have been.
The practical consequence: a Restylane responder rate and a Juvederm responder rate are not comparable, and neither is comparable within the Restylane range. Any page ranking these products on their headline percentages is comparing different rulers. We make the same point on chin filler, where three approved products used three different scales.
The comparison nobody publishes
Here is what the Refyne and Defyne trial document actually reports. The primary measure was change on the 5-point Wrinkle Severity Rating Scale at 24 weeks, each side of the face judged by a blinded evaluator. The control was an FDA-approved hyaluronic acid filler with similar characteristics to the Restylane product, without lidocaine.
| Timepoint | Restylane Refyne | Control filler | Restylane Defyne | Control filler |
|---|---|---|---|---|
| Week 24 | 78.8% | 83.5% | 77.8% | 85.2% |
| Week 36 | 78.0% | 80.5% | - | - |
| Week 48 | 66.7% | 72.8% | - | - |
The comparison filler out-scored the Restylane product at every timepoint reported. On the underlying scale the gap was small: a mean change of -1.3 for Refyne against -1.4 for its control at Week 24.
This is where the trial design matters, so read the next sentence before drawing a conclusion. Both studies were non-inferiority studies, and both passed. The question was never "which is better", it was "is Refyne not worse than this comparator by more than a set margin", and the answer was that it is not. A non-inferiority result is a legitimate basis for approval and is used across medicine.
But it does mean two things a marketing page will not tell you. First, the published evidence does not show Refyne or Defyne outperforming the filler they were tested against. Second, if you are choosing between Refyne and something else on the strength of a percentage, the percentage was never designed to support that choice. Refyne had 170 patients treated and Defyne 162, so these are real studies of a reasonable size. They simply answered a narrower question than the number suggests.
Which product for which area
Because so many of these overlap, the useful question at a consultation is not "do you use Restylane" but "which one, and why that one".
- Lips. Silk and Kysse are both approved here. Kysse is the newer and was tested on lip fullness specifically, with 88% of patients scored as responders at 8 weeks. Silk's approval covers lip augmentation plus the fine lines around the mouth.
- Cheeks and midface. Lyft and Contour. Lyft is also the one approved for hands and, since November 2025, the chin.
- Nasolabial folds. Refyne, Defyne and Lyft. Defyne is worded for deep folds, which is the practical difference.
- Chin. Defyne and Lyft, both for mild to moderate retrusion. See chin filler for how they compare with the Juvederm option.
- Under the eye. Eyelight, and only Eyelight. This is the one area in the range where there is no second choice, and see under-eye and tear trough filler for why this region is treated with more caution than any other.
If your injector proposes a Restylane product for an area not in that list, the product is approved but that use of it is not studied. Off-label use is legal and routine. It just means no regulator reviewed a dose or a depth for what is about to happen to you.
Eyelight, and the only filler trial that checked vision
The hollow under the eye is the area patients worry about most, and with reason: it sits closest to the vessels that matter. Eyelight's trial is the only filler study we have read that formally monitored vision. Snellen visual acuity, confrontational visual fields and ocular motility were assessed at screening and throughout the study.
What it found, stated in full because half of it read alone would be alarming:
- Over 97% of treated participants had no worsening of visual acuity at any assessment point.
- 25 events of worsening on the Snellen test were reported by 6% (19 of 316) of treated subjects during the study. For 8 subjects, 9 events, the decline persisted to the end of the study, with a maximum of a two-line decrease.
- Every one of those changes was assessed as mild, and as not related to the product or the injection procedure.
- All participants had normal extraocular muscle tests at every visit.
- One participant had a visual field change 20 days after treatment, in one quadrant of one eye. It was mild, judged unrelated, and had resolved by day 32.
The trial itself: 380 people screened, 47 screen failures, 333 randomised, 287 to Eyelight and 46 to no treatment, across 16 sites, mean age 44.4. The primary measure was a blinded evaluator's live assessment of a 4-grade hollowing scale at 3 months, each eye separately. Responder rates were 89.6% with a needle and 84.9% with a cannula.
One number in that document deserves attention. On the investigator's global assessment, improvement ran from 87.5% to 99.5% in treated participants against 2.8% to 10.8% in the untreated group. That is a far bigger gap than the untreated groups in the jawline trials produced, which tells you the scale used here is much harder to score as spontaneously improved.
How long each one lasted
Only two of these products have published curves we can read directly, and they do not measure the same thing.
Kysse, on lip fullness, declined steadily: 88% of patients were responders at 8 weeks (155/177), 82% at 16 weeks, 77% at 24 weeks, 69% at 32 weeks and 66% at 40 weeks (110/166). So roughly two thirds still had a measurable result at about nine months. For how that compares with other lip products, see how long lip filler lasts.
Refyne, on nasolabial folds, held 78.8% at 24 weeks, 78.0% at 36 weeks and 66.7% at 48 weeks. Two thirds at about eleven months.
Those two figures look similar and are not. Kysse was measured on a lip fullness scale and Refyne on a wrinkle severity scale, at different intervals, against different comparators. The honest summary across the range is most people who respond still show a result at nine to twelve months, with a gradual decline rather than a sudden end. Anything more precise than that is not supported by these documents.
What the FDA adverse event database holds
The FDA's MAUDE database collects reports of device problems. It is not a rate, and it is easy to misread: a report is a report, not a confirmed injury, and products sold in greater volume for longer accumulate more of them.
| Product | Reports |
|---|---|
| Restylane (base brand) | 172 |
| Restylane Lyft, all variants | 194 |
| Restylane Defyne | 113 |
| Restylane Kysse | 93 |
| Restylane Refyne | 49 |
| Restylane Silk | 45 |
| Restylane Contour | 33 |
| Restylane Eyelight | 3 |
Do not read that as a safety ranking. Eyelight's 3 reports reflect a product approved in 2023, not a safer gel. Lyft's 194 reflect a decade on the market under two names. The Refyne trial reported device and injection-related adverse events in 7.1% of patients (12 of 170), which is a rate, and is the more useful figure.
Counting these correctly is harder than it looks, and worth explaining because it is where most published numbers go wrong. Lyft is sold as "Lyft", "Lyft with Lidocaine" and "Lyft Lidocaine", so a search for one name finds a third of the reports. Search loosely instead and you pick up other manufacturers' products entirely. The 194 above is the sum of Lyft's three real variant names, with mismatches removed. For what the reports actually describe, and what is genuinely urgent, see filler complications.
What to ask before you book
- Which Restylane product, and is my area inside its approval? Eight products, each approved for specific places. "We use Restylane" is not an answer.
- Why that one rather than the other Restylane option? Lips, cheeks, midface, nasolabial folds and chin each have two candidates in this range.
- Does it contain lidocaine? The "-L" and "with Lidocaine" versions are the same gel plus anaesthetic. It affects comfort, not result.
- How many millilitres in total, across the whole course? Ask for the total, not a per-syringe price.
- For under-eye work, why Eyelight and not something else? It is the only product in the range approved for infraorbital hollowing.
- What is the plan if I want it removed? Every product here is hyaluronic acid, so hyaluronidase can dissolve it. That is a genuine advantage over Radiesse, which it cannot.
For the wider picture, our dermal fillers guide covers what the FDA record shows across every approved filler, Juvederm covers the range most often compared with this one, and filler recovery sets out what the first two weeks involve.
Frequently asked questions
How many Restylane products are there?
What is the difference between Restylane Refyne and Defyne?
Is Restylane better than Juvederm?
Which Restylane is best for lips?
How long does Restylane last?
Can Restylane be dissolved?
Is Restylane safe under the eyes?
What does the "-L" in Restylane-L mean?
Sources
Every figure on this page was read from the documents below rather than from a clinic or a manufacturer's marketing. They open in a new tab so you can check any claim here against its source.
- Summary of Safety and Effectiveness Data, P140029, Restylane Refyne and Restylane Defyne, US Food and Drug Administration
- Summary of Safety and Effectiveness Data, P140029/S021, Restylane Kysse, US Food and Drug Administration
- Summary of Safety and Effectiveness Data, P040024/S135, Restylane Eyelight, US Food and Drug Administration
- Dermal fillers (soft tissue fillers), US Food and Drug Administration
- Dermal fillers, American Society of Plastic Surgeons
Know the count before the quote. The unit count is half the bill, and a low per-unit rate recovered by a high unit count is the commonest way a deal is not one. How to tell.
Deciding which area, not how many units? Botox by facial area covers what each zone actually achieves, which four are FDA approved, and the things Botox cannot fix at all.
