Restylane Kysse, New Hyaluronic Acid Filler, Was Just FDA-Approved for Lips

RESTYLANE KYSSE | Lea Prinzivalli | Allure Magazine |

It’s designed to create softer, more natural-looking lips.

There are many, many reasons to look forward to the days when mandatory telemedicine appointments are behind us, and we can once again sit in a doctor’s chair for non-emergency visits. Galderma, the pharmaceutical giant behind Restylane, Sculptra, Cetaphil, and Proactiv, has just given us one more: Restylane Kysse, a hyaluronic acid injectable designed specifically for lip injections. Kysse is pronounced kiss, get it?

Restylane Kysse has already been available in international markets, but as of May 2020, it’s now approved by the Food and Drug Administration for usage in the United States.

Kysse is a hyaluronic acid filler, which places it in a categories similar to Juvéderm and other Restylane products. The innovation here is that Kysse uses Galderma’s proprietary XpresHAn (aka “expression”) Technology. As Melanie Palm, a San Diego-based board-certified dermatologist and clinical investigator in the phase three trials of the new drug, explained to Allure, the new filler changes the way that hyaluronic acid binds inside your lips. “[The hyaluronic acid] is bound to itself, so it stretches, and then goes back to its prior space,” she says. “When you’re talking, smiling, kissing, it has the ability to integrate into the tissue where it’s injected and mold to your tissue. It becomes one with [your lips].”

Lip filler can have a tendency to feel uncomfortable or difficult to get used to, like there’s an unknown substance attached to your lips (because there is!), explains Palm. She found that Kysse felt more natural, in addition to looking more natural. “It’s not only believable to everybody else, but it is believable to you,” she says. “It just seems seamless with your own lips.”

Alisa Lask, general manager and vice president of the U.S. Aesthetic Business at Galderma, breaks down the results of the clinical trials: “Study results showed that Restylane Kysse provides lip fullness, improves the appearance of the lines above the mouth and leaves patients satisfied with their results,” she says. “We found that by week eight after treatment, at least 90 percent of patients were satisfied with their lips. Specifically, with the shape of their upper and lower lips (93 percent and 95 percent, respectively).”

That said, we predict this new approval to be a hit among professionals and patients alike, and there are a few reasons they may be right. First of all, clinical trials showed that Kysse has the potential to last for almost a year. As Palm points out, other lip fillers typically last three to six months. Secondly, there’s a bang-for-your-buck factor. Filler is sold by the syringe; costs typically range from $500 to $2,000 per syringe.

“We found in the study that we could use 20 percent less product compared to the control group,” says Palm. “In that clinical study, we used about a little over one and a half syringes, but in reality, I think one syringe goes a long way for our typical filler patient,” she says. “It’s actually going to be pretty cost-effective.” That means that, if Kysse works for you, you may be able to pay less money for filler that lasts longer.

Kysse is FDA-approved for anyone over 21 years old and, according to Palm, it works for a “large cache of patients.” She suggests it for patients who are in their 20s or 30s who are looking for “enhanced” lips, as well as 50- to-60-year-old patients who want to bring volume back into the lips.

The one downside? We can’t tell you about Kysse from experience, as doctors’ offices in many parts of the country are still closed to in-person appointments. Galderma is minding the latest pandemic-related guidance. “Our team has started taking orders for Restylane Kysse, and we are working closely with aesthetic providers so it is available to patients as soon as possible, as physician offices begin to safely reopen,” says Lask.

Just one more item to add to your post-pandemic to-do list.

https://www.allure.com/story/restylane-kysse-hyaluronic-acid-filler-fda-approved-for-lips