Jenny Mollen and her go-to dermatologist, New York City’s Patricia Wexler, MD have such a close rapport that they can, and often do, finish each other’s sentences.

And it was like this from the get-go, shares Dr. Wexler. “It’s a chemistry that doesn’t happen that often,” she admits. “I love all of my patients, but I don’t always get to express my personality. You can’t do that with every patient.”

Ms. Mollen, 40, clearly isn’t just any patient. She is an actress, New York Times-best selling author, and something of an Instagram phenom. She calls Dr. Wexler “Pat” and sees her often for treatments, touch ups, or just to say hi and show off a new coat. Ms. Mollen and her husband actor Jason Biggs often double date with Dr. Wexler and her husband.

“It just works,” they both say, almost in unison.

“She is clearly an influencer, but I don’t call her that,” Dr. Wexler adds. That said, Ms. Mollen is influential. Her Instagram account boasts 408k followers who take her advice on everything and anything from making kids lunches (she packs an elaborate Bento box for her sons) and all things parenting and style including Botox Cosmetic and other anti-aging tweakments.

Dr. Wexler and Ms. Mollen sat down with Modern Aesthetics® as part of a media blitz to promote Allergan’s first annual National Botox Cosmetic Day, which was held on November 20.

So how did Ms. Mollen celebrate National Botox Day? Scooping up special “Buy one/Get one” gift cards for everyone on her holiday list. “It’s the best Christmas gift and it can expose my friends who haven’t gotten there yet. It’s a cool way to say ‘Listen, I am hooking you up.’“

Ms. Mollen’s book titles “I Like You Just the Way I Am” and “Live Fast, Diet Hot” speak volumes about how she feels about growing older. She first started getting Botox in her late twenties. “The one in my eleven was getting very strong and I wanted to curb it,” she recalls. At the time she was living in Los Angeles and there was no stigma attached to injectables or any cosmetic treatment. “It wasn’t a secret. Everyone did it, including my mom.”

Ms. Mollen and Dr. Wexler are now in a committed doctor-patient relationship, and Ms. Mollen admits that she had her share of “flings” with other aesthetic health care providers. She was very public about the severe bruising she experienced after having her lip fillers dissolved.

“I like filler,” she says. “I may have gone to the wrong doctor at first.”

Dr. Wexler had her at “skin cancer check.”

“You can go to any storefront med spa to get injections at your own risk, but I wanted to give her a proper exam,” Dr. Wexler says. Ms. Mollen’s first visit involved a head-to-toe skin cancer screening. “I liked that she was a straight shooter,” Ms. Mollen recalls. The rest is history.


Revance’s DAXI Now One Step Closer to FDA Nod

Revance Therapeutics, Inc. has submitted a Biologics License Application (BLA) to the FDA for daxibotulinumtoxinA for Injection (DAXI) in the treatment of moderate to severe glabellar lines.

Under the current Prescription Drug User Fee Agreement (PDUFA VI), the FDA has agreed to file acceptable applications within 60 days of receipt and to review the majority of BLAs within 10 months following the Day 60 filing date. Based on that timeline, Revance anticipates potential product approval in the second half of 2020.

“The submission of our BLA represents a significant milestone in the company’s history and initiates our transition from a development company to a commercial organization. I’m incredibly excited about the opportunity to introduce the first truly novel advancement in neuromodulator products in over 30 years. We believe that a long-acting neuromodulator product will fill a significant, unmet need in both aesthetics and therapeutics and that the market is hungry for innovation,” says Mark Foley, President and Chief Executive Officer of Revance, in a news release. “As we manufacture our own product in the United States, the BLA filing represents a monumental achievement for a company of our size, which was only made possible through the incredible dedication and commitment of our employees.”

DAXI has been evaluated in three Phase 3 trials (SAKURA 1, 2, 3). Both SAKURA 1 and SAKURA 2 demonstrated that half of the patients treated maintained none or only mild frown lines for at least 24 weeks (approximately six months), after a single treatment. Additionally, frown lines did not return to their pre-treatment severity for at least 26–28 weeks for half of the patients treated. Results from the two pivotal Phase 3 trials, SAKURA 1 and SAKURA 2, were recently presented at the American Society for Dermatologic Surgery (ASDS) 2019 Annual Meeting and published in Plastic and Reconstructive Surgery as well as accepted for future publication in the Journal of the American Academy of Dermatology.


Allergan, Exicure Enter Collaboration Deal to Discover and Develop SNA-based Treatments for Hair Loss Disorders

Exicure, Inc. and Allergan’s wholly-owned subsidiary, Allergan Pharmaceuticals International Limited, have entered into a global collaboration agreement to discover and develop novel treatments for hair loss disorders based on Exicure’s proprietary spherical nucleic acid (SNA) technology.

Under terms of the agreement, Allergan will receive exclusive access and options to license SNA-based therapeutics arising from two collaboration programs related to the treatment of hair loss disorders. Exicure will receive an upfront payment of $25 million and will conduct discovery and development in two collaboration programs for hair loss disorders. In the event that Allergan exercises an option, Allergan will be responsible for the clinical development and commercialization of the licensed products. Exicure will be eligible to receive development and regulatory milestones of up to $97.5 million per program and commercial milestones of up to $265 million per program. Exicure will also be eligible to receive tiered royalties on worldwide net product sales of mid-single-digit to mid-teens percentages on worldwide net product sales.

“We are excited to combine our knowledge of nucleic acid therapeutics with Allergan’s deep expertise in medical aesthetics to develop and commercialize innovative treatments for hair loss disorders,” says Dr. David Giljohann, CEO of Exicure. “This collaboration is an exciting opportunity to advance Exicure’s SNA technology in an important new therapeutic area.”


Dr. Roy Geronemus Awarded the Vic Narurkar, MD Innovations in Aesthetic Dermatology Lectureship Award

Roy Geronemus, MD of Laser and Skin Surgery Center of New York received, The American Society for Dermatologic Surgery inaugural Vic Narurkar, M.D., Innovations in Aesthetic Dermatology Lectureship Award.

Dr. Geronemus received the award at the 2019 ASDS annual meeting in Chicago. He delivered the lecture “Expanding the Scope of Dermatologic Surgery Through Lasers and Related Technologies” at the meeting. This lecture honors the legacy of Dr. Vic Narurkar.

Dr. Narurkar is a great educator and exercised excellent clinical judgment and care to his patients,” Dr. Geronemus told Practical Dermatology®, Modern Aesthetics’®, sister publication, in a recent interview.


Merz: Cellfina for Cellulite Cleared for 5 Years of Benefit

The FDA has cleared a new indication for Cellfina that shows the benefits of treatment last for five years, an increase from the previous three-year indication. Cellfina from Merz demonstrated five-year improvement in the appearance of cellulite on the buttocks and thighs of adult females. Five-year durability makes Cellfina the longest-lasting FDA-cleared treatment for cellulite on the market.

The new indication is based on observations by an independent physician using before and after patient photographs at five years post-treatment. Results showed that after a single in-office treatment, 100 percent of follow-up patients still had noticeable improvements. Follow-up studies at one, three, and five years after a single in-office treatment showed sustained improvements.

“Cellfina is the benchmark and continues raising the bar for any other cellulite treatments, with both longevity of results and effectiveness,” said board-certified Miami cosmetic dermatologist Jeremy Green, MD “Cellulite is an emotionally charged medical condition that affects 85 percent of women worldwide. While the data has clearly shown that Cellfina works, and does so for five years, the FDA clearance indicates to consumers that they can, and should, expect to see proven, long-lasting results after treatment with Cellfina.”

“This formal recognition from the FDA is a significant milestone for Cellfina customers, their patients, and Merz. Research shows women oftentimes feel defeated by their battle with cellulite, and we want to make sure our customers have an effective cellulite treatment option,” says Merz Americas CEO Bob Rhatigan. “Cellfina is the only cellulite treatment FDA-cleared for visible results that last five years. We are proud of this new indication, and it is a true testament to Cellfina’s efficacy and our commitment to bring customers the latest innovations in medical aesthetics.”


American Society for Dermatologic Surgery Annual Meeting Updates

New and emerging technologies as well as innovative approaches to existing treatments took the spotlight at the 2019 annual meeting of the American Society for Dermatologic Surgery in Chicago this fall.

Presenters addressed aesthetic topics like small volume filler placement. “Focus on certain areas,” says Terrence Keaney, MD. He notes that when using small volumes, “you can optimize filler by placing it in certain locations where you get bigger bang for your buck.”

In a similar vein, Sabrina Fabi, MD explained how she achieves dramatic improvement in the lower face—including indirect lip enhancement—by injecting in the chin. “With just 1cc of filler…in the chin, you can have beautiful aesthetic outcomes,” Dr. Fabi says.

In an interview with Joel L. Cohen, MD, dermatologist Nazanin Saedi, MD talked about maximizing treatments through combinations. For example, she often pairs a pico treatment for pigmentation with ablative or non-ablative lasers to address color and texture in a single session. RF microneedling plus low-energy CO2 is another popular option, she says. (Dr. Cohen interviewed various speakers from the meeting for Modern Aesthetics® magazine’s sister publication Practical Dermatology®. You can watch the interviews online at PracticalDermatology.com.)

Merz Aesthetics brought spokesmodel Christie Brinkley to the exhibit hall, where she addressed changing attitudes about aesthetics. A generation ago, hair coloring was considered taboo, she said with a nod to the old tagline “only her hairdresser knows for sure.” Today, women are open about their aesthetic treatments, she says.

A poster presentation from Endo included data from the RELEASE-1 and RELEASE-2 Phase 3 studies, previously presented at the 2019 Aesthetic Society meeting. The identically designed, randomized, double-blinded, placebo-controlled trials assessed the efficacy, safety, and tolerability of collagenase clostridium histolyticum (CCH) for the treatment of cellulite in women. A greater percentage of the 843 women treated during the studies met the primary endpoint of response with CCH versus placebo in both studies. Most adverse events observed in CCH-treated patients were transient, mild/moderate, and injection-site related (e.g., bruising, pain, induration, pruritus, erythema, and discoloration).

Endo launched a “Redefining Scientific Artistry” campaign at the ASDS Annual Meeting with a mobile-first website intended to serve as an educational platform for consumers and physicians who want to learn more about the company and cellulite science.

Allergan celebrated the enrollment of six million members in its Brilliant Distinctions program at a reception during the meeting.

Galderma reported positive results of its randomized, controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of HARK for lip augmentation, noting that the data are being used to support FDA submission of the novel injectable.


FDA Proposes Boxed Warning on Breast Implant Risks

The FDA released a statement on its continued efforts to protect women’s health and enhance safety information available to patients considering breast implants.

In draft guidance issued in late October, the FDA proposed labeling recommendations to manufacturers of breast implants to help ensure women receive and understand information regarding the benefits and risks of breast implants. The draft guidance offers numerous recommendations to help ensure women have access to this information, including that manufacturers incorporate a boxed warning and patient decision checklist in the device’s labeling, update recommendations for patient screening for device rupture, and more.

The FDA guidance says that the boxed warning should help communicate risks that patients may not know, including that breast implants are not lifetime devices; the chances of developing complications increase the longer a patient has the implant and additional surgery may be required to address the complications; and that breast implants have been associated with the risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and may be associated with systemic symptoms.

The draft guidance also includes a recommendation that manufacturers include a patient decision checklist to help guide discussion during a patient’s consultation with a surgeon. A checklist gives patients the opportunity to acknowledge individual risks of breast implants, such as potential risks from the surgery, the risk of BIA-ALCL and risk of implant rupture, among others.

“We believe the information contained in the example of the patient decision checklist can contribute to a patient’s understanding of both the benefits and risks of breast implants,” the statement says.

Earlier this year in July, just days after surgeons from the British Association of Aesthetic Plastic Surgeons (BAAPS) and elsewhere called for warnings on silicone-filled breast implants due to risk of “breast implant illness,” Allergan issued a voluntary worldwide recall of Biocell textured breast implants and tissue expanders due to concerns of BIA-ALCL.

Following the recall, Modern Aesthetics® spoke to Bryan G. Forley, MD about what is known about the reported cases of BIA-ALCL. Watch the interview now: modernaesthetics.com/videos/breast-implants-assessing-the-risk-for-bia-alcl


Baring Private Equity Asia to Acquire Lumenis

Baring Private Equity Asia’s affiliated private equity funds are acquiring Lumenis. The transaction, which values Lumenis at an enterprise value of more than $1 billion, remains subject to the customary regulatory approval process. It is expected to be completed in early 2020.

“Baring Private Equity Asia’s (BPEA) investment is a tremendous vote of confidence in Lumenis and in the achievements of our entire global organization. In recent years, we have developed and introduced multiple groundbreaking technological solutions that have redefined our industry and opened entirely new market segments.,” says Tzipi Ozer-Armon, CEO of Lumenis, in a news release.


Dr. Mary Lynn Moran Takes the Helm at AAFPRS

Mary Lynn Moran, MD is the new President of The American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS).

Dr. Moran, who will serve the 2019-2020 year term, is the first female to serve as AAFPRS president. She is a facial plastic surgeon in Franklin, TN.


Hologic to Sell Cynosure

Hologic is selling the Cynosure medical aesthetics business to an affiliate of investment funds managed by Clayton, Dubilier & Rice for a total purchase price of $205 million in cash, subject to certain closing adjustments. This is a tenth of the $1.6B that Hologic, a women’s health care company, paid two years ago to acquire Cynosure.

Net of these adjustments, Hologic expects net cash proceeds of approximately $138 million, the company reports.

“Divesting our medical aesthetics business will enable us to focus on what we do best – helping women and their families live healthier lives through early detection of disease,” says Steve MacMillan, the Company’s Chairman, President and Chief Executive Officer, in a news release. “Since we acquired Cynosure in 2017, it has significantly underperformed our expectations. We believe this transaction will unlock value for Hologic shareholders, and at the same time provide Cynosure and its employees the best opportunity to succeed in the medical aesthetics marketplace. Moving forward, our business development strategy remains focused on the smaller, tuck-in deals that have been performing well for us and strengthening our core franchises.”


Venus Concept Completes Merger with Restoration Robotics

Following the completion of the merger, Venus Concept completed a $28 million equity financing by EW Healthcare Partners, HealthQuest Capital, SEDCO Capital and others.

Restoration Robotics changed its name to Venus Concept Inc. The combined company will commence trading on November 8, 2019 on the Nasdaq Global Market under the ticker symbol “VERO.”

“We are pleased to announce the closing of our merger with Restoration Robotics,” says Domenic Serafino, Chief Executive Officer of Venus Concept, in a news release. “We have made significant progress in enhancing our financial condition with our recent financing activities. The outlook for Venus Concept is very positive and we believe the combined company is well-positioned as a leading player in both the global minimally invasive/non-invasive medical aesthetics market and the minimally invasive surgical hair restoration market.”

Following the merger, Restoration Robotics moved its corporate headquarters to Toronto, Canada.


Kylie Jenner Sells Majority Stake in Beauty Business to Coty

Kylie Jenner sold a $600M majority stake in Kylie Cosmetics and Kylie Skin to Coty Inc.

Under the terms of the agreement, Coty will acquire a 51 percent ownership in the partnership for $600M. The acquisition is expected to close in the third quarter of fiscal year 2020. Coty’s family of brands includes Covergirl, Max Factor, Rimmel, Clairol, Sally Hansen, Adidas and Nautica.

MY NEW FAVORITE THING: TEMPSURE FIRM

“Cynosure’s Tempsure Firm 60mm handpiece uses innovative technology to gently heat deep tissue. It allows me to confidently treat larger areas of the body quickly and effectively. The results I’ve been seeing are absolutely fantastic, and the quick treatment times are an added benefit from both a physician and patient perspective. TempSure Firm’s combination of radiofrequency heat and specialized massage head help the skin look more youthful and evenly textured—and because it gently and gradually delivers heat, my clients actually enjoy the treatments and say it feels like being at the spa. With no downtime, they’re free to drive themselves home after their appointments. The addition of TempSure Firm to the TempSure platform has been a total game changer for my practice and the results really do speak for themselves.”


Bruce E. Katz, MD
Medical Director, JUVA Skin and Laser Center, New York City
Clinical Professor of Dermatology, The Mount Sinai School of Medicine
Director, Cosmetic Surgery & Laser Clinic, Mount Sinai Medical Center

CLARIFICATION

Please note that in the September/October edition of Modern Aesthetics® magazine, our device listings inadvertantly contained duplicate listings for RF Microneedling devices.

Cutera’s Secret RF listing should have appeared on p. 46.

Secret RF uses semi-insulated and non-insulated tips to deliver RF energy within various adjustable depths of skin from 0.5-3.5mm. It has been joined by the company’s newest device truSculpt flex, which is FDA-cleared for the improvement of abdominal tone, strengthening of the abdominal muscles, and development of a firmer abdomen. In addition, it is cleared for the strengthening, toning and firming of buttocks and thighs.

An updated PDF is available here.