NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, announced today that a peer-reviewed, post hoc analysis published in Aesthetic Surgery Journal showed with high consistency that males treated with Jeuveau® (prabotulinumtoxinA-xvfs), the company’s flagship neurotoxin product, had higher responder rates than those treated with BOTOX® (onabotulinumtoxinA) across nearly all time points examined.
The post-hoc analyses were performed on a subpopulation of male patients treated for glabellar lines with either a single dose of 20U Jeuveau® or BOTOX® in a double-blind, randomized Phase III clinical trial. The analysis included a total of 56 males, with 25 receiving Jeuveau® and 31 receiving BOTOX®. Compared with BOTOX-treated males, percentages of males treated with Jeuveau® who had a ≥1 point improvement on the glabellar line severity scale at maximum frown were higher at all post-baseline time points by an average of 10.1% across nearly all visits, though with the small sample size, results did not reach statistical significance. Similar trends were observed for efficacy endpoints based on the global aesthetic improvement and subject satisfaction scales, and no serious adverse events were related to either toxin.
“Published comparative clinical data focused on treating male patients with botulinum toxins is very limited,” said Rui Avelar, M.D., Chief Medical Officer and Head of Research and Development, Evolus. “This post hoc analysis provides for a head-to-head comparison in a more difficult to treat patient population and may help evaluate the relative potency of Jeuveau and BOTOX.”
“Male patients can be challenging to treat as their frown muscles, the corrugators and the procerus, tend to have more muscle mass than women,” said Nowell Solish, MD, F.R.C.P., cosmetic dermatologist and principal investigator. “The ad hoc analysis demonstrates that Jeuveau is an excellent option for male patients as seen in their high response rates. This is encouraging news for the many male patients who are embracing botulinum aesthetic treatments.”
Botulinum toxin injections continue to be the most common non-surgical cosmetic procedure performed in both males and females and are rapidly increasing in popularity among males. According to the American Society of Plastic Surgeons, more than 265,000 botulinum toxin treatments were administered to men in 2020 alone.
“Cosmetic toxin injections in men have increased in popularity by an astonishing 380% between 2000 and 2018,” said David Moatazedi, President and CEO, Evolus. “While we remain focused on the millennial demographic, it is important for us to understand how the underpenetrated and growing male patient population responds to treatment. We are excited to see the favorable results in this analysis, which further validate our ongoing clinical study examining an ‘extra-strength’ dosing option of Jeuveau to provide more options for treating diverse patient populations.”
Jeuveau® is used for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) in adults below 65 years of age. Since the launch of Jeuveau®, an estimated 2 million treatments have been administered by more than 8,100 purchasing customers nationwide. The largest head-to-head pivotal study versus BOTOX® to date evaluated the safety and efficacy of Jeuveau®, enrolling more than 2,100 patients as part of Evolus’ TRANSPARENCY clinical development program. The product is approved for sale in the United States under the brand name Jeuveau® and in Canada under the brand name Nuceiva®.
About Evolus, Inc.
Evolus (Nasdaq: EOLS) is a performance beauty company evolving the aesthetic neurotoxin market for the next generation of beauty consumers through its unique, customer-centric business model and innovative digital platform. Our mission is to become a global, multi-product aesthetics company based on our flagship product, Jeuveau® (prabotulinumtoxinA-xvfs), the first and only neurotoxin dedicated exclusively to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology. Visit us at www.evolus.com, and follow us on LinkedIn, Twitter, Instagram or Facebook.
Jeuveau® and Nuceiva® are registered trademarks of Evolus, Inc.
Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd.
BOTOX® is a registered trademark of Allergan, Inc.
IMPORTANT SAFETY INFORMATION FOR JEUVEAU® (prabotulinumtoxinA-xvfs)
JEUVEAU may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of JEUVEAU:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.
Do not use JEUVEAU if you: are allergic to any of the ingredients in JEUVEAU (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®/BOTOX® Cosmetic), abobotulinumtoxinA (DYSPORT®), or incobotulinumtoxinA (XEOMIN®); have a skin infection at the planned injection site; or are a child.
JEUVEAU dosing units are not the same as, or comparable to, any other botulinum.
Tell your healthcare provider about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, Myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of JEUVEAU.
Tell your healthcare provider about all your medical conditions, including: any side effects from botulinum toxin products, including dry eye; breathing, swallowing, bleeding, or heart problems; plans to have surgery; weakness of forehead muscles; drooping eyelids; have had surgery on your face; are pregnant or breastfeeding or plan to become pregnant or breastfeed (it is not known if JEUVEAU can harm your unborn baby or passes into breast milk).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using JEUVEAU with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your healthcare provider that you have received JEUVEAU in the past.
Especially tell your healthcare provider if you: have received any other botulinum toxin product in the past and the last 4 months, and exactly which product you received (such as BOTOX, BOTOX Cosmetic, MYOBLOC, DYSPORT, or XEOMIN).
JEUVEAU may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of treatment with JEUVEAU. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
JEUVEAU can cause other serious side effects including: allergic reactions such as itching, rash, red itchy welts, wheezing, trouble breathing, asthma symptoms, or dizziness or feeling faint. Tell your healthcare provider or get emergency medical help right away if you develop wheezing or trouble breathing, or if you feel dizzy or faint. Heart problems. Irregular heartbeat and heart attack that have caused death, have happened in some people who received botulinum toxin products. Eye problems such as dry eye, reduced blinking, and corneal problems. Tell your healthcare provider if you develop eye pain or irritation, sensitivity to light, or changes in your vision.
The most common side effects include: headache; eyelid drooping, upper respiratory tract infection, and increased white blood cell count.
JEUVEAU is a prescription medicine that is injected into muscles and used in adults for a short period of time (temporary) to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines).
The risk information provided here is not complete. For more information about JEUVEAU, see the full Prescribing Information including BOXED WARNING, and Medication Guide, visit evolus.com or talk to your healthcare provider.
To report side effects associated with use of JEUVEAU, please call 1-877-EVOLUS1/1-877-386-5871. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Exclusively licensed and manufactured for: Evolus, Inc., 520 Newport Center Drive, Suite 1200, Newport Beach, CA 92660
This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including statements based on our current expectations, assumptions, estimates and projections about future events, our business, financial condition, results of operations and prospects, our industry and the regulatory environment in which we operate. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “designed,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, or other comparable terms intended to identify statements about the future. The company’s forward-looking statements include, but are not limited to, statements related to the company’s expectations regarding certain marketing and clinical programs, the performance of Jeuveau® and consumer adoption of Jeuveau®.
The forward-looking statements included herein are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond our control, include, but are not limited to uncertainties associated with our ability to comply with the terms and conditions in the Allergan/Medytox Settlement Agreements, our ability to fund our future operations or obtain financing to fund our operations, the continued impact of COVID-19 or inflation on our business and the economy generally, uncertainties related to customer and consumer adoption of Jeuveau®, the efficiency and operability of our digital platform, competition and market dynamics, and our ability to maintain regulatory approvals of Jeuveau® and other risks described in our filings with the Securities and Exchange Commission, including in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the Securities and Exchange Commission on March 3, 2022 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, filed with the SEC on August 2, 2022. These filings can be accessed online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, we undertake no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events. If we do update or revise one or more of these statements, investors and others should not conclude that we will make additional updates or corrections.