Botulinum toxin injections have been used both in the face and neck for many years. However, injection into the sternocleidomastoid muscle (SCM) has only been done to treat neck spasms. In this study botulinum toxin will be injected into the SCM to determine if this will result in a temporary slimming effect on the neck and produce a more feminine, youthful neck contour.

Start Date14 May 2025

Sponsor / Collaborator

Boston Medical Center

[+1]

NCT06604832

/ Active, not recruitingPhase 1IIT

Effects of PrabotulinumtoxinA-xvfs on Facial Skin Quality, Fine Wrinkles, and Texture

The goal of this split-face clinical trial is to test the efficacy of microtox in improving facial skin quality, fine wrinkles, and texture. Participants will:
* be randomly assigned to Group A (which will receive 20 units of neuromodulator on the left side of the forehead and a placebo saline treatment on the right side) or Group B (which will receive 20 units of neuromodulator on the left side of the forehead and 20 units of a different neuromodulator brand on the right side as a comparator)
* have one treatment session at week 0, and two live assessment visits at weeks 2 and 12
* have their pictures taken at each visit to track progress

Start Date03 Sep 2024

Sponsor / Collaborator

Evolus, Inc.

NCT05807412

/ CompletedEarly Phase 1

A Prospective, Single-center, Blinded, Randomized, Split-face Study Evaluating the Spread of PrabotulinumtoxinA-xvfs Versus OnabotulinumtoxinA in the Treatment of Forehead Rhytides

Ten subjects will be enrolled in the study. Each subject will have their left and right forehead randomly assigned to receive 4 units of PrabotulinumtoxinA-xvfs or OnabotulinumtoxinA. Subjects will be reassessed at 2 weeks for evaluation of rhytide diminution around each injection point to assess relative diffusion of each drug in the forehead.

Start Date01 May 2023

Sponsor / Collaborator

Lupo Center For Aesthetic & General Dermatology, L L C

[+1]

100 Clinical Results associated with Prabotulinumtoxina-XVFS(Evolus, Inc.)

100 Translational Medicine associated with Prabotulinumtoxina-XVFS(Evolus, Inc.)

100 Patents (Medical) associated with Prabotulinumtoxina-XVFS(Evolus, Inc.)

Literatures (Medical) associated with Prabotulinumtoxina-XVFS(Evolus, Inc.)

31 Dec 2025·ANNALS OF MEDICINE

Research progress in the use of botulinum toxin type a for post-stroke spasticity rehabilitation: a narrative review

Review

Author: Wang, Ya ; Zhu, Zongjun ; Guan, Yuanyuan ; Xiao, Hongbo ; Xu, Qianwen

BACKGROUND:

Stroke is a leading cause of long-term disability and death worldwide. Spasticity after stroke seriously affects patients' quality of life. If this state persists for a long time, it will lead to severe joint atrophy, reduced motor coordination, and even permanent disability. Therefore, clinical research has focused on the treatment of spasticity and the recovery of motor function after stroke.

AIM:

The aim of this paper is to explore the use of botulinum toxin type A in the rehabilitation of spasticity after stroke and to provide a theoretical basis for optimizing rehabilitation strategies, highlighting its potential value in reducing spasticity and improving motor function.

METHOD:

This article reviews the latest research progress on the application of BTX-A in spasticity after stroke, discusses the potential and challenges of BTX-A in reducing spasticity and improving motor function in patients with stroke.

RESULT:

Botulinum toxin type A (BTX-A) is a local muscle paralytic agent that has received extensive attention in recent years for its application in reducing muscle spasticity and promoting post-stroke rehabilitation.

CONCLUSION:

This article confirms that botulinum toxin type A has a significant clinical effect in treating muscle spasticity after stroke and also helps improve motor function restoration in patients. Studies have shown that botulinum toxin type A injections are effective in reducing spasticity and, when combined with rehabilitation training, can facilitate the recovery of motor function in post-stroke patients. Therefore, botulinum toxin type A has a broad application prospect in the rehabilitation of post-stroke spasticity.

01 Oct 2025·FACIAL PLASTIC SURGERY

The Role of Toxins and Fillers in Optimizing Perioral Rejuvenation

Review

Author: Lorenz, F. Jeffrey ; Walen, Scott G. ; Schopper, Heather K.

Abstract:

Neurotoxins and fillers have become increasingly popular for restoring age-related changes in the perioral region. This review examines their roles in optimizing perioral rejuvenation.The perioral region composes the lower third and middle three-fifths of the face. It includes the lips, surrounding perioral skin, chin, muscles of facial expression, maxilla, and mandible. Changes in the perioral region are significant contributors to the visible signs of aging.Ideal candidates for perioral rejuvenation with toxin and filler are individuals experiencing age-related rhytids or volume loss who are interested in minimally invasive, nonsurgical interventions.Neurotoxins like Botox, Xeomin, Dysport, Jeuveau, and Daxxify are used to relax muscles that contribute to rhytids. Common treatment areas and techniques include perioral rhytids, lip flip, oral commissure elevation, dimpled chin, and gummy smile. Dermal fillers such as hyaluronic acid, calcium hydroxyapatite, and poly-L-lactic acid restore volume in areas like the nasolabial folds, lips, marionette lines, chin, prejowl sulcus, and perioral rhytids.Neurotoxins and dermal fillers offer effective, minimally invasive solutions for perioral rejuvenation. With an understanding of underlying anatomy, proper patient selection, and precise injection techniques, facial plastic surgeons can achieve natural, youthful results with minimal downtime.

01 Jul 2025·Cirugia espanola

Study of morphological changes observed on abdominal CT scan after preoperative treatment with botulinum toxin type A in patients with midline incisional hernias or lateral component

Article

Author: Jullien Petrelli, Ariel Christian ; Jiménez Jiménez, Félix Javier ; Alonso Poza, Alfredo ; Del Corral Rodríguez, Javier ; Ramírez Calderón, Jessie ; García-Conde Delgado, María ; Hernández García, Miguel ; Argudo Garijo, Salvador

INTRODUCTION:

Preoperative treatment with botulinum toxin (BT) is very common in complex incisional hernias, although it lacks clear indications.

METHODS:

Between July 2019 and May 2022, measurements of the thickness and length of the lateral abdominal wall, transverse diameter of the abdomen and diameter of the hernia defect were taken from patient CT scans both pre- and post-treatment with BT at our hospital. In order to establish differences between patients with lateral and midline hernias, a logistic regression analysis was performed.

RESULTS:

The study included 23 patients: 17 had midline hernias, and 6 had lateral hernias (4 right and 2 bilateral). We observed increased length of the right wall (1.15 ± 1.64 cm; P = .0029), left wall (1.96 ± 1.74 cm; P < .0001) and transverse abdominal diameter (2.85 ± 4.83 cm; P < .0001), and a reduction in the thickness of the right (-0.54 ± 0.53 cm; P < .0001) and left walls (-0.58 ± 0.42 cm; P < .0001). There were no differences in the transverse diameter of the defect (-0.01 ± 1.37 cm; P = .4593). After logistic regression, increased right wall length (OR 14.99; 95%CI 1.58-142.12) and transverse abdominal diameter (OR 9.33; 95%CI 1.13-76.68) was more likely to be observed in patients with midline hernias than in those with lateral locations.

CONCLUSIONS:

Preoperative treatment with BT appears to be more effective in patients with midline hernias than in those with lateral locations.

123

News (Medical) associated with Prabotulinumtoxina-XVFS(Evolus, Inc.)

06 Oct 2025

·news.abbvie.com

AbbVie Announces Positive Topline Results from Phase 2 ELATE Trial Evaluating OnabotulinumtoxinA (BOTOX®) for the Treatment of Upper Limb Essential Tremor

OnabotulinumtoxinA (BOTOX®) met the primary endpoint in the Phase 2 trial, demonstrating a statistically significant improvement from baseline in the Tremor Disability Scale-Revised (TREDS-R) total unilateral score compared to placebo.1 The trial also met all six secondary endpoints.2 Results from safety analyses were generally consistent with the well-established safety profile of onabotulinumtoxinA.1 NORTH CHICAGO, Ill., Oct. 6, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the Phase 2 ELATE trial evaluating the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared to placebo for the treatment of upper limb essential tremor. The study met its primary endpoint, demonstrating statistically significant improvements in the Tremor Disability Scale-Revised (TREDS-R) of onabotulinumtoxinA compared to placebo at week 18. Specifically, the onabotulinumtoxinA group showed a greater reduction in TREDS-R total unilateral score compared to placebo, with scores of -2.61 versus -1.61, (p=0.029).1 The study also met all six secondary endpoints.2 "Essential tremor is a progressive neurological condition that affects millions worldwide and often results in unsatisfactory outcomes with current treatments," said Daniel Mikol, M.D., Ph.D., vice president, neuroscience development, AbbVie. "No new pharmacological treatments have been approved in the U.S. for essential tremor for more than 30 years. These results represent a significant advance and demonstrate further proof of mechanism for a neurotoxin as a potential treatment option to help patients and healthcare providers manage this challenging condition." Safety results were generally consistent with the well-established safety profile of onabotulinumtoxinA. Muscular weakness was the most common adverse event, with reported rates of 24.5% in the onabotulinumtoxinA group versus 2.3% in the placebo group. Instances were localized and transient and most were classified as mild or moderate in nature.1 Results from the study will be presented at the International Congress of Parkinson's Disease and Movement Disorders® on October 8, 2025. The use of BOTOX® for essential tremor is not approved by the U.S. Food and Drug Administration (FDA) or any other global regulatory authority and its safety and efficacy have not been evaluated by regulatory authorities. About the ELATE Study The ELATE trial was a Phase 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of onabotulinumtoxinA for the treatment of upper limb essential tremor in adults. The primary efficacy measure was the change in the Tremor Disability Scale-Revised (TREDS-R) total score across seven unilateral items from baseline across weeks 15, 18 and 21. Secondary outcome measures included activity of daily living assessment, various tremor assessment scales and global impression of severity scores. More information on the ELATE trial can be found on www.clinicaltrials.gov. About Essential Tremor Essential tremor is the most common movement disorder, impacting approximately 25–60 million individuals worldwide.3 This condition complicates physical activities due to uncontrollable and involuntary action tremors and furthermore often results in depression, anxiety and social embarrassment, thereby affecting overall quality of life.4 Current treatment options are limited in both efficacy and tolerability often leaving patients with few viable options. About BOTOX® (onabotulinumtoxinA) BOTOX® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Today, BOTOX® is FDA-approved for multiple therapeutic indications, including chronic migraine, overactive bladder, leakage of urine (incontinence) due to detrusor overactivity associated with a neurologic condition in adults and in pediatric patients five years of age and older, cervical dystonia, adult and pediatric spasticity, and severe underarm sweating (axillary hyperhidrosis). BOTOX® is not FDA-approved for essential tremor. BOTOX® (onabotulinumtoxinA) Important Information U.S. Indications BOTOX® (onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used: To treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken To treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to a neurologic disease when another type of medicine (anticholinergic) does not work well enough or cannot be taken To treat overactive bladder due to a neurologic disease in children 5 years of age and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken To prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years and older To treat increased muscle stiffness in people 2 years of age and older with spasticity To treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older To treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years of age and older BOTOX is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older. It is not known whether BOTOX is safe and effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine). BOTOX has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. It is not known whether BOTOX is safe and effective for severe sweating anywhere other than your armpits. U.S. IMPORTANT SAFETY INFORMATION BOTOX 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 BOTOX: 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 preexisting 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; drooping eyelids; hoarseness or change or loss of voice; trouble saying words clearly; loss of bladder control; trouble breathing; and trouble swallowing. There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus. BOTOX may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving BOTOX. If this happens, do not drive a car, operate machinery, or do other dangerous activities. Do not receive BOTOX if you are allergic to any of the ingredients in BOTOX (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), Xeomin® (incobotulinumtoxinA), Jeuveau® (prabotulinumtoxinA-xvfs), Daxxify® (daxibotulinumtoxinA-lanm), or Letybo® (letibotulinumtoxinA-wlbg) (this may not be a complete list of all botulinum toxin products); have a skin infection at the planned injection site. Do not receive BOTOX for the treatment of urinary incontinence if you have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing. Due to the risk of urinary retention (difficulty fully emptying the bladder), only patients who are willing and able to initiate catheterization posttreatment, if required, should be considered for treatment. Patients treated for overactive bladder: In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX compared to 2 of the 542 treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX 100 Units (n = 36) was 63 days (minimum 1 day to maximum 214 days), as compared to a median duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo (n = 2). Patients with diabetes mellitus treated with BOTOX were more likely to develop urinary retention than nondiabetics. Adult patients treated for overactive bladder due to a neurologic disease: In clinical trials, 30.6% of adult patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection required catheterization for urinary retention following treatment with BOTOX 200 Units, as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days), as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7). Among adult patients not using CIC at baseline, those with multiple sclerosis were more likely to require CIC postinjection than those with spinal cord injury. The dose of BOTOX is not the same as, or comparable to, another botulinum toxin product. Serious and/or immediate allergic reactions have been reported, including itching; rash; red, itchy welts; wheezing; asthma symptoms; dizziness; or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX should be discontinued. Tell your doctor 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 BOTOX. Tell your doctor if you have any breathing-related problems. Your doctor may monitor you for breathing problems during treatment with BOTOX for spasticity or for detrusor overactivity associated with a neurologic condition. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX. Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX for their blepharospasm, especially in people with certain nerve disorders. BOTOX may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch. Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX. Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in adults receiving BOTOX for upper limb spasticity. Upper respiratory infections were also reported more frequently in adults with prior breathing-related problems with spasticity. In pediatric patients treated with BOTOX for upper limb spasticity, upper respiratory tract infections were reported more frequently. In pediatric patients treated with BOTOX for lower limb spasticity, upper respiratory tract infections were not reported more frequently than placebo. Autonomic dysreflexia in patients treated for overactive bladder due to a neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in adult patients treated with BOTOX 200 Units compared with placebo (1.5% versus 0.4%, respectively). Tell your doctor about all your medical conditions, including if you have or have had bleeding problems; have plans to have surgery; had surgery on your face; have weakness of forehead muscles, trouble raising your eyebrows, drooping eyelids, and any other abnormal facial change; have symptoms of a UTI and are being treated for urinary incontinence (symptoms of a UTI may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX passes into breast milk). Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX in the past. Tell your doctor if you received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, Xeomin®, Jeuveau®, Daxxify®, or Letybo® in the past (this may not be a complete list of all botulinum toxin products; tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners. Other side effects of BOTOX include dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; eye problems such as double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes; drooping eyebrows; and upper respiratory tract infection. In adults being treated for urinary incontinence, other side effects include UTI and painful urination. In children being treated for urinary incontinence, other side effects include UTI; bacteria, white blood cells, and blood in the urine. In patients being treated for urinary incontinence, another side effect includes the inability to empty your bladder on your own. If you have difficulty fully emptying your bladder on your own after receiving BOTOX, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again. For more information, refer to the Medication Guide or talk with your doctor. 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. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. Please see BOTOX® full Product Information, including Boxed Warning and Medication Guide. Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. AbbVie Media: Liz Tang, Ph.D. liz.tang@abbvie.com Investors: Liz Shea liz.shea@abbvie.com References: SOURCE AbbVie

Clinical ResultPhase 2Drug Approval

01 Oct 2025

·www.globenewswire.com

AEON Biopharma Announces FDA BPD Type 2a Meeting for ABP-450 on November 19

- Meeting date aligns with prior guidance - - FDA to review AEON’s analytical development plan and initial data - IRVINE, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a biopharmaceutical company developing ABP-450 (prabotulinumtoxinA) as a BOTOX® (onabotulinumtoxinA) biosimilar, today announced that the U.S. Food and Drug Administration (FDA) has scheduled a Biosimilar Biological Product Development (BPD) Type 2a meeting for ABP-450 on November 19, 2025, in line with prior guidance. The meeting will focus on AEON’s analytical development plan under the 351(k) biosimilar pathway, including its framework for assessing key quality attributes and its initial similarity data. The objective of the discussion is to establish alignment with FDA on the scope and approach of the remainder of AEON’s analytical analysis - a foundational step in advancing ABP-450’s biosimilar development. “The FDA’s scheduling of our BPD Type 2a meeting represents an important milestone in the development of ABP-450,” said Rob Bancroft, President and Chief Executive Officer of AEON. “Alignment with FDA on the analytical framework is essential in the biosimilar pathway, and we look forward to constructive dialogue on our proposed plan and early results as we advance ABP-450 as a potential biosimilar to BOTOX®.” AEON expects to provide an update on the outcome of the meeting following its completion and receipt of official FDA minutes. Upcoming Milestones 4Q 2025: FDA BPD Type 2a meeting expected to provide alignment on analytical development plan for ABP-450. About AEON Biopharma AEON Biopharma is a biopharmaceutical company seeking accelerated and full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX. The U.S. therapeutic neurotoxin market exceeds $3.0 billion annually, representing a major opportunity for biosimilar entry. The Company’s lead asset is ABP-450 injection for debilitating medical conditions. ABP-450 is the same botulinum toxin complex currently approved and marketed for cosmetic indications by Evolus, Inc. under the name Jeuveau®. ABP-450 is manufactured by Daewoong Pharmaceutical in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada, and European Medicines Agency. The product is approved as a biosimilar in India, Mexico, and the Philippines. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. To learn more about AEON, visit www.aeonbiopharma.com. Forward-Looking Statements Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance. For example, statements regarding meetings with the FDA, the timing of completion of, or outcome of results from, analytical studies, or potential determination that ABP-450 is highly similar to the reference product for currently approved and future therapeutic indications are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the FDA’s response to the results of AEON’s primary structure analysis; (ii) the FDA’s response to the results of the select functional analyses completed by Daewoong Pharmaceutical; (iii) the expected Type 2a meeting with the FDA and potential path forward to biosimilarity designation; (iv) AEON’s ability to receive full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX on an accelerated timeline or at all; (v) the outcome of any legal proceedings that may be instituted against AEON or others; (vi) AEON’s future capital requirements; (vii) AEON’s ability to raise financing in the future; (viii) AEON’s ability to continue to meet continued stock exchange listing standards; (ix) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; (x) the outcomes from any meetings or discussions with regulatory authorities; (xi) the timing of, or results from, any testing performed on AEON’s product; and (xii) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements. Contacts Investor Contact: Laurence WattsNew Street Investor Relations+1 619 916 7620laurence@newstreetir.com Source: AEON Biopharma

Drug Approval

12 Aug 2025

·investors.aeonbiopharma.com

AEON Biopharma Reports Second Quarter 2025 Financial Results and Provides Corporate Update

– Multiple near-term potential milestones, including anticipated completion of primary structure analysis and select functional analyses in 3Q’25 – – Type 2a meeting with the FDA anticipated in 4Q’25– – Cash runway expected to support operations through FDA meeting and regulatory feedback – IRVINE, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a biopharmaceutical company seeking an accelerated and full-label U.S. market entry by developing ABP-450 (prabotulinumtoxinA) as a BOTOX® (onabotulinumtoxinA) biosimilar, announced its financial results for the second quarter ended June 30, 2025, and provided a business update. “We have made strong progress this quarter toward the major biosimilar development milestones laid out for the second half of 2025. We are poised to report the results from our primary structure analysis and select functional analyses for ABP-450, which will be critical components of our planned Type 2a meeting with the FDA, anticipated to take place in 4Q’25. We expect our FDA meeting to provide clarity regarding our development path moving forward, as we work to bring greater patient accessibility to therapeutic neurotoxins as quickly as possible,” said Rob Bancroft, AEON’s President and Chief Executive Officer. “With our workstreams advancing as planned, we are now in a position to refine our prior guidance and move confidently into this next phase of development.” Mr. Bancroft continued, “By utilizing the 351(k) pathway, we aim to bring ABP-450 to the U.S. market under a single FDA approval that could cover all of BOTOX’s currently approved and future therapeutic indications. Further, subject to approval, we believe ABP-450 has the potential to offer a more cost-effective solution that would enhance patient access and improve economics for both payers and healthcare providers. The over $3.0 billion U.S. therapeutic market remains controlled by a single toxin, and we believe our entry into the market would be welcomed by stakeholders.” Recent Clinical and Corporate Highlights Advancing ABP-450’s biosimilar development through the comparative analytical assessment (CAA) – AEON is pursuing a 351(k) biosimilar regulatory pathway for ABP-450, using BOTOX® as the reference product for potentially all therapeutic indications for which BOTOX is approved. The CAA forms the analytical framework required for biosimilar approval. The Company believes it is aligned with the FDA on the initial key requirements of the CAA. AEON expects to complete primary structure and select functional analyses for ABP-450 in 3Q’25. The Company anticipates a Type 2a meeting with the FDA in 4Q’25 to discuss results of these studies and align on the next steps in the development of ABP-450. Supportive preclinical toxicology, manufacturing, and other data, which are expected to support the CAA and the Type 2a meeting, have been previously generated by the Company and its licensing partner, Daewoong Pharmaceutical. Liquidity and Capital Resources – The Company reported cash and cash equivalents of $8.4 million as of June 30, 2025, which is expected to be sufficient to fund the Company’s operating plan through the fourth quarter of 2025 and its planned Type 2a meeting with the FDA targeted in the 4Q’25. AEON expects to complete primary structure and select functional analyses for ABP-450 in 3Q’25. The Company anticipates a Type 2a meeting with the FDA in 4Q’25 to discuss results of these studies and align on the next steps in the development of ABP-450. Supportive preclinical toxicology, manufacturing, and other data, which are expected to support the CAA and the Type 2a meeting, have been previously generated by the Company and its licensing partner, Daewoong Pharmaceutical. Expected Upcoming Milestones 3Q’25 – Expected completion of primary structure analysis performed by the Company. 3Q’25 – Expected completion of select functional analyses performed by Daewoong Pharmaceutical, the Company’s licensing partner. 4Q’25 – Expected results and path forward from Biosimilar Biological Product Development (BPD) Type 2a FDA meeting. About AEON Biopharma AEON Biopharma is a biopharmaceutical company seeking accelerated and full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX. The U.S. therapeutic neurotoxin market exceeds $3.0 billion annually, representing a major opportunity for biosimilar entry. The Company’s lead asset is ABP-450 injection for debilitating medical conditions. ABP-450 is the same botulinum toxin complex currently approved and marketed for cosmetic indications by Evolus, Inc. under the name Jeuveau®. ABP-450 is manufactured by Daewoong Pharmaceutical in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada, and European Medicines Agency. The product is approved as a biosimilar in India, Mexico, and the Philippines. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. To learn more about AEON, visit www.aeonbiopharma.com. Forward-Looking Statements Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance. For example, statements regarding meetings with the FDA, the timing of completion of, or outcome of results from, primary comparative analytical studies, or potential determination that ABP-450 is highly similar to the reference product for currently approved and future therapeutic indications are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the completion of the primary structure analysis by AEON; (ii) the completion of select functional analyses by Daewoong Pharmaceutical; (iii) the expected Type 2a meeting with the FDA and potential path forward to biosimilarity designation; (iv) AEON’s ability to receive full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX on an accelerated timeline or at all; (v) the outcome of any legal proceedings that may be instituted against AEON or others; (vi) AEON’s future capital requirements; (vii) AEON’s ability to raise financing in the future; (viii) AEON’s ability to continue to meet continued stock exchange listing standards; (ix) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; (x) the outcomes from any meetings or discussions with regulatory authorities; (xi) the timing of, or results from, any testing performed on AEON’s product; and (xii) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements. Contacts Investor Contact: Laurence Watts New Street Investor Relations +1 619 916 7620 laurence@newstreetir.com Source: AEON Biopharma The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and include the accounts of the Company and its controlled subsidiaries.

License out/inDrug ApprovalFinancial Statement

100 Deals associated with Prabotulinumtoxina-XVFS(Evolus, Inc.)

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Glabellar frown lines	Canada	Evolus, Inc.	16 Aug 2018
Benign Essential Blepharospasm	South Korea	Daewoong Pharmaceutical Co., Ltd.	29 Nov 2013

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Nasolabial fold wrinkles	NDA/BLA	China	Daewoong Pharmaceutical Co., Ltd.	28 Jan 2022
Masticatory Muscles, Hypertrophy Of	Phase 3	United States	Daewoong Pharmaceutical Co., Ltd.	04 Mar 2020
cervical dystonia	Phase 2	United States	AEON Biopharma Sub, Inc.	29 Mar 2021
Torticollis	Phase 2	United States	AEON Biopharma Sub, Inc.	29 Mar 2021
Migraine Disorders	Phase 2	United States	AEON Biopharma Sub, Inc.	01 Mar 2021
Migraine Disorders	Phase 2	Australia	AEON Biopharma Sub, Inc.	01 Mar 2021
Migraine Disorders	Phase 2	Canada	AEON Biopharma Sub, Inc.	01 Mar 2021
Migraine Without Aura	Phase 2	United States	AEON Biopharma Sub, Inc.	01 Mar 2021
Migraine Without Aura	Phase 2	Australia	AEON Biopharma Sub, Inc.	01 Mar 2021
Migraine Without Aura	Phase 2	Canada	AEON Biopharma Sub, Inc.	01 Mar 2021

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05167864 (JBDX, CTgov)	Not Applicable	-	143	Onabotulinumtoxina for Injection (OnabotulinumtoxinA)	helgtsmsuq(xpjvofufkg) = haxgizbsbl bwuaeqohou (anryycwisl, 5.0) View more	-	17 Jan 2025
				Abobotulinumtoxina for Injection (AbobotulinumtoxinA)	helgtsmsuq(xpjvofufkg) = psitlaxcbb bwuaeqohou (anryycwisl, 5.2) View more
NCT05320393 (CTgov)	Phase 2	Glabellar frown lines	154	PrabotulinumtoxinA-Xvfs (Study Drug)	chqrdjexwv(ukmasannib) = ovginvaqjt ezjlltmxmi (twjezwrkgg, hksqlpqywp - ngicmbzmsg) View more	-	04 Sep 2024
				OnabotulinumtoxinA (OnabotulinumtoxinA)	chqrdjexwv(ukmasannib) = gvokwvyvsf ezjlltmxmi (twjezwrkgg, rfbpsiqkjh - apqafiwhlb) View more
NCT04845178 (GlobeNewswire) Manual	Phase 2	Migraine Disorders	325	ABP-450 150 U	gpjsescqzy(zckcszlucl) = jwflfqtvfn hohnzxzaao (zazrqghzib ) Not Met	Negative	03 May 2024
				ABP-450 195 U	gpjsescqzy(zckcszlucl) = efohvugxja hohnzxzaao (zazrqghzib ) Not Met
Biospace Manual	Phase 2	Glabellar frown lines	150	BOTOXau Extra-Strength 40U	cvmmuqjxnx(zfxaprkazd) = zzwdgdzfta birhpmcwbo (hpdpvnlrhq )	Positive	17 Apr 2024
				Jeuveau Extra-Strength 40U	-
NCT04871451 (Corporate Publications) Manual	Phase 2	cervical dystonia	51	ABP-450	dapvicvrzg(psvwzxtbty) = piomamynwx zvidenubeo (iwasqqrusz ) View more	Positive	28 Jan 2024
				ABP-450 (Low (≤800))	dapvicvrzg(psvwzxtbty) = rdpvgmhxyj zvidenubeo (iwasqqrusz ) View more
NCT04845178 (ABP-20001, NEWS) Manual	Phase 2	Migraine Disorders	305	ABP-450ABP-450 150U	iselmztooc(zdupdfxaje) = yofglezbvv kpovcczzib (pissubxvqf ) View more	Positive	19 Oct 2023
				ABP-450 195U	iselmztooc(zdupdfxaje) = ulndnylcgv kpovcczzib (pissubxvqf ) View more
EADV2023	Phase 3	-	46	PrabotulinumtoxinA 50U	hleahdlxvb(wtaxqghqgg) = All reported complications were mild, transient, and subsided spontaneously without requiring any other interventions. Mostly headache and ecchymosis. qdcfhypqms (njvygcnmrb ) View more	Positive	11 Oct 2023
MDS2023	Phase 2	Isolated cervical dystonia	70	ABP-450 150U	bqeevkltka(enhqlrzqbc) = zpupptnsyw nfgqlclfih (wxstypczel ) View more	Positive	27 Aug 2023
				ABP-450 250U	bqeevkltka(enhqlrzqbc) = uutlzwogiw nfgqlclfih (wxstypczel ) View more
NCT02184988 (Pubmed \| Aesthet Surg J) Manual	Phase 2	Glabellar frown lines	352	PrabotulinumtoxinA	eeuzokrqlj(atfmeoluwb) = jdtlaiplzg obtfrbvjxg (eakdomgbya ) View more	Positive	12 Nov 2021
NCT02428608 (Pubmed \| Aesthet Surg J) Manual	Phase 2	Glabellar frown lines	570	PrabotulinumtoxinA	wxcjpluilq(qomehlmrcg) = cqvgalzxhy lknrlzcbav (ouztbfboof ) View more	Positive	12 Nov 2021

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