"Extra-Strength" Formulation of Jeuveau® Demonstrates Effects Lasting 26 Weeks in Interim Phase II Data Results, Representing Prolonged 6-Month Performance
"Extra-strength" 40U formulation achieves one-point improvement on the Glabellar Lines Scale with the duration of effect lasting 26 weeks, representing a prolonged 6-month performance
Results indicate a favorable safety profile; no serious adverse events reported and 88% of all adverse events were mild
Potential new "extra-strength" formulation would expand Evolus' Jeuveau® offering
Trial completion expected mid-2023; final results anticipated to be presented in 2H 2023
NEWPORT BEACH, Calif., January 28, 2023--(BUSINESS WIRE)--Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today presented interim data from its Phase II clinical study evaluating an "extra-strength" formulation for extended duration of Jeuveau® (prabotulinumtoxinA-xvfs), its flagship neurotoxin product, at the 2023 International Master Course on Aging Science (IMCAS) World Congress in Paris. The data indicated that the "extra-strength" formulation of Jeuveau® at 40U (units) achieved a duration profile of 6 months or 26 weeks.
The extra-strength glabellar line study is a multicenter, double-blind, randomized Phase 2 trial following 150 patients for up to 12 months or until the patient loses their correction. The study has three arms: Jeuveau® Extra-Strength 40U and two active controls, Botox® 20U and Jeuveau® 20U. An interim analysis was performed to assess the safety and efficacy of the extra-strength formulation. At this time, Jeuveau® Extra-Strength has demonstrated 6 months (26 weeks) duration across the three metrics presented, including the time it takes for patients to return to their baseline Glabellar Line Scale (GLS) score after their treatment, time back to baseline for patients with a response of none or mild on the GLS, and the duration of effect of at least a one-point GLS improvement. The adverse events profile across all three arms was similar. The severity rating demonstrated that 88% of the events were mild and 12% were moderate. Importantly, no serious adverse events were reported.
"The interim results of this study are a significant step forward in our strategy to provide a longer-duration treatment option to patients, and we are very pleased that the ‘extra-strength’ formulation of Jeuveau® demonstrated a duration of 6 months or 26 weeks," said Rui Avelar, M.D., Chief Medical Officer and Head of Research and Development, Evolus. "These data are very encouraging from a safety and efficacy perspective as we are seeing improvement on the GLS scale together with a favorable safety profile."
"The combination of results from the ‘original strength’ trials and this exciting new ‘extra-strength’ data further reinforces Jeuveau’s® efficacy, offering greater flexibility for clinicians and patients while maintaining a similar safety profile between the two formulations," said David Moatazedi, President and Chief Executive Officer, Evolus. "‘Extra-strength’ Jeuveau® can be formulated using the same vial used for the ‘original strength’ Jeuveau® simply by modifying the reconstitution. This provides the runway for an exciting option for our customers that already value Jeuveau’s® unique precision profile while delivering natural-looking results."
Jeuveau® is approved 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. The safety and efficacy of Jeuveau® was evaluated through the company’s TRANSPARENCY program, the largest head-to-head pivotal study versus BOTOX® to date. The product is approved for sale in the U.S. under the brand name Jeuveau® and in Canada under the brand name Nuceiva®, which launched in Europe in the second half of 2022, and received regulatory approval in Australia in January 2023.
About "Extra-Strength" Glabellar Line Study
The "Extra-Strength" Glabellar Line Study is a multicenter, double blind, randomized trial that is following 150 patients for up to 12 months at five study sites. The study includes two active controls – the currently approved 20 units of Jeuveau® and 20 units of BOTOX® Cosmetic – which will be compared to 40 units of Jeuveau®. In addition to evaluating the safety, efficacy and duration of effect, this study will also help assess the potential clinical tradeoffs for patients when using the longer duration option.
Investor Webcast Information
Evolus will host a live conference call and webcast for investors on Monday, January 30th at 11:30 am Eastern to discuss the findings. To connect to the webcast, please access the link on the Events & Presentations page of our website at www.evolus.com. For audio-only access to the webcast, dial (877) 407-6184 (U.S.) or (201) 389-0877 (international). An archived copy of the webcast will be available on our website later that day.
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.
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," "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 the company’s ongoing clinical trial, related research and development activities and commercial potential for the "extra-strength" formulation.
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 other outbreaks of contagious diseases on our business, unfavorable global economic conditions and the impact on consumer discretionary spending, uncertainties related to customer and consumer adoption of Jeuveau®, the efficiency and operability of our digital platform, competition and market dynamics, our ability to successfully launch and commercialize our products in new markets, our ability to successfully broaden our product portfolio, our ability to maintain regulatory approvals of Jeuveau® or obtain regulatory approvals for new product candidates or indications and other risks described in our filings with the Securities and Exchange Commission, including in the section entitled "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 filed with the Securities and Exchange Commission on November 8, 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.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230128005004/en/
David K. Erickson, Evolus, Inc.
Vice President, Investor Relations