Nancy Reau, MD, is Professor of Internal Medicine, Richard B. Capps Chair of Hepatology, Associate Director of Solid Organ Transplantation, and Section Chief of Hepatology at Rush University Medical Center.

Amanda Van Jacobs, MS, RDN, LDN, CCTD, is a transplant dietician at Rush University Medical Center.

Jessica Mellinger, MD, is a senior staff hepatologist at Henry Ford Health.

Why Alcohol Recommendations in the New Dietary Guidelines Fall Short

In this segment from the latest episode of 

Liver Lineup: Updates & Unfiltered Insights

, the conversation around the newly updated US Dietary Guidelines turns to one of their most debated and most limited areas: alcohol.

While the guidelines emphasize reducing ultra-processed foods, Kimberly Brown, MD, presses the panel on whether there was a similarly clear message when it came to alcohol consumption. According to guest Jessica Mellinger, MD, the answer is yes, but only in the broadest sense.

“The message on alcohol was pretty limited,” Mellinger explains. “It was basically: drink less.”

While she says she does not disagree with that recommendation, she notes that the guidance lacks specificity and clinical nuance, particularly for patients with liver disease or conditions known to increase alcohol-related risk. Compared with prior guidelines, which defined “moderate” drinking using sex-based thresholds, the updated recommendations remove specific quantities altogether, reflecting a growing body of evidence suggesting that even low levels of alcohol consumption are associated with adverse health outcomes.

Mellinger highlights cancer risk as one of the most consistent findings in the literature, noting that alcohol is a known carcinogen with measurable associations even at low intake levels. Although certainty diminishes at lower levels of consumption, the overall trend has been toward recommending less alcohol across populations. From a hepatology standpoint, she emphasizes that this shift aligns with what clinicians increasingly see in practice.

However, Mellinger views the updated guidance less as a comprehensive directive and more as a starting point for individualized clinical conversations. In her alcohol-associated liver disease clinic, discussions often extend well beyond quantity and frequency, focusing instead on how alcohol affects a patient’s health, relationships, and quality of life.

From her perspective, there is no safe level of alcohol consumption she can ethically recommend to patients with liver disease based on the available data. Rather than offering reassurance around low-level use, she encourages clinicians to meet patients where they are, exploring motivation, readiness for change, and realistic next steps toward reduction or abstinence.

Nancy Reau, MD, adds that important at-risk populations remain absent from the public-facing guidance. Beyond pregnancy, she notes that patients who have undergone gastric bypass surgery represent another growing group for whom alcohol use carries significant risk, yet they are not explicitly addressed.

Ultimately, the panel agrees that while “drink less” may be an appropriate population-level message, it leaves critical gaps for clinicians to fill.

Editors’ Note: Relevant disclosures for Reau include AbbVie, Gilead, Salix, Arbutus, and VIR. Relevant disclosures for Brown include Mallinckrodt Pharmaceuticals, Gilead, Salix, Intercept, Ipsen, and Madrigal. Relevant disclosures for Mellinger include GlaxoSmithKline. Van Jacobs reports no relevant disclosures.

Brooks A. New Dietary Guidelines Draw Criticism For High Fat Dairy, Protein Recommendations. HCPLive. January 8, 2026. Accessed February 9, 2026. 

https://www.hcplive.com/view/new-dietary-guidelines-draw-criticism-high-fat-dairy-protein-recommendations

AASLD. AASLD Raises Concern Over Removal of Evidence-Based Alcohol Guidance in 2025–2030 Dietary Guidelines for Americans. January 9, 2026. Accessed February 9, 2026. 

https://www.aasld.org/aasld-raises-concern-over-removal-evidence-based-alcohol-guidance-2025-2030-dietary-guidelines

Videos

In this segment of a Liver Lineup episode, experts discuss where the new US Dietary Guidelines miss the mark for alcohol recommendations.

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Hepatology

Lina Jia, MD, PhD, from Beth Israel Deaconess Medical Center, Harvard Medical School, and Xuanwu Hospital in China.

 receiving magnetic seizure therapy (MST) experienced faster symptom improvement, fewer cognitive adverse events, and better overall tolerability compared to adults, according to a new prospective comparative study.

The findings address a critical evidence gap in neuromodulation for depression, as most existing data are derived from adult populations despite important developmental, neurobiological, and safety considerations in younger patients.

MST has emerged as a potential alternative to modified electroconvulsive therapy, offering antidepressant efficacy with reduced cognitive burden.

 However, age-related differences in response and tolerability have not been well characterized.

Investigators conducted a single-center, prospective study of 128 patients with treatment-resistant MDD, including 67 adolescents (ages 12–18) and 61 adults (ages 19–65), all treated with a standardized MST.

 Participants were assessed at baseline, 72 hours post-treatment, and 3 months post-treatment using validated clinical and safety measures: 17-item Hamilton Depression Rating Scale (HAMD-17), Hamilton Anxiety Rating Scale (HAMA), Brief Psychiatric Rating Scale (BPRS), Clinical Global Impressions (CGI), Columbia-Suicide Severity Rating Scale (C-SSRS), and the Montreal Cognitive Assessment (MoCA). Cognitive subdomains were analyzed to detect domain-specific effects.

Both age groups showed significant reductions in depressive, anxiety, and comorbid psychiatric symptoms following MST, with effects maintained at 3 months. However, adolescents demonstrated a more rapid early response, with significantly lower HAMD-17 and HAMA scores at 72 hours compared with adults (

 <.001), while adults reached similar symptom severity by 3 months.

Cognitive outcomes differed by age: adults experienced greater short-term declines in delayed recall and executive function at 72 hours, whereas adolescents showed no significant cognitive change, with no between-group differences at 3 months. Adults also reported greater rates of headache, memory complaints, fatigue, and transient vital sign abnormalities, while adolescents experienced fewer somatic adverse events. The data suggest that MST is effective across age groups but may offer distinct clinical and safety advantages in adolescent MDD.

In a Q&A, investigator Lina Jia, MD, PhD, from Beth Israel Deaconess Medical Center, Harvard Medical School, and Xuanwu Hospital in China, discussed the implications of these findings.

 How do your results support the use of MST as a treatment option for adolescent MDD compared to standard pharmacotherapy or cognitive behavioral therapy? What advantages does MST offer?

 Our findings support MST as a promising neuromodulation option for adolescents with treatment-resistant depression, demonstrating clinically meaningful symptom reduction and a favorable tolerability profile. In our cohort, adolescents showed faster early symptom improvement (within 72 hours) and better cognitive preservation compared with adults, alongside fewer somatic side effects, suggesting that MST may be particularly suitable when rapid symptom relief and cognitive safety are prioritized.

While our study did not directly compare MST against medication or CBT, the results position MST as a potential alternative for adolescents who have [an] insufficient response to standard treatments or require faster improvement. Importantly, comparative data indicate MST may have cognitive safety advantages over ECT, including faster reorientation and fewer subjective cognitive or physical adverse effects in a randomized clinical trial. Clinically, this matters because concerns about cognitive adverse effects often constrain the use of seizure therapies in youth.

 In your study, adolescents showed faster symptom improvement at 72 hours post-MST compared to adults. What neurobiological or developmental factors might explain this difference?

 A plausible explanation is developmental neuroplasticity. Adolescence is characterized by ongoing maturation of prefrontal-limbic circuits, synaptic pruning, and dynamic changes in excitation-inhibition balance. Such developmental biology may confer greater responsiveness to stimulation-induced network modulation, resulting in earlier clinical change after MST. Our interpretation is consistent with the broader literature that seizure-based neuromodulation can alter large-scale functional connectivity patterns implicated in depressive symptomatology.

 Despite faster early improvements in adolescents, adults showed continued symptom reduction over three months. How should clinicians interpret these different trajectories?

 Clinicians can interpret these trajectories as age-dependent time courses of treatment response rather than differences in ultimate benefit. Adolescents may show a stronger “early response signal,” whereas adults may demonstrate a more gradual but sustained improvement over follow-up. This pattern is compatible with the idea that seizure-based therapies can trigger both acute state shifts and longer-term network-level adaptations that unfold over weeks to months.

Longitudinal neuroimaging studies of seizure therapies (such as ECT) support the concept that connectivity changes evolve over time and may relate to delayed clinical gains. For adolescents, early improvement may help engagement and adherence. For adults, lack of dramatic early change should not be misinterpreted as non-response; continued improvement may occur with time.

 Suicidal ideation decreased in both groups, but adults had a greater reduction. How might psychosocial or developmental factors contribute to this age-related difference?

 Developmental context may modulate how rapidly suicidal ideation resolves. In adolescents, suicidality can be more tightly linked to acute psychosocial stressors, family or environmental conflict, peer dynamics, and impulsivity, such that symptom relief may not immediately translate into proportional reductions in suicidal thinking. In adults, suicidal ideation may track more closely with core depressive severity and thus show larger reductions in tandem with symptomatic improvement.

For adolescents, MST or ECT should be delivered within a comprehensive care framework that includes structured psychotherapy and coordinated family and school support to reduce the risk of relapse and sustain clinical gains.

 Adolescents required slightly more MST sessions on average than adults. What factors should guide the number of sessions in clinical practice?

 Session number should be guided by a measurement-based care framework, balancing symptom trajectory, functional recovery, and tolerability. Key factors include baseline severity, pace of response, comorbidity (such as anxiety [or] trauma), and cognitive or somatic adverse effects. Because seizure therapies show inter-individual variability in response, session tailoring is standard practice.

 What are the limitations of this study clinicians should be aware of when applying these findings in practice?

 Clinicians should interpret these findings within several important contextual considerations. Our study was not randomized and did not include a direct comparator against pharmacotherapy, CBT, or ECT, which limits formal comparative effectiveness conclusions. In addition, the single-center design and modest sample size may affect generalizability, and heterogeneity in concomitant medications and comorbidities could introduce residual confounding. Cognitive outcomes were assessed using brief screening measures, which may not capture subtle domain-specific changes, and longer follow-up will be necessary to define [the] durability of response and cognitive trajectories.

As one of the first prospective real-world evaluations of MST in adolescents, our findings provide clinically informative evidence regarding feasibility, safety, and age-related response patterns, and support the need for larger controlled trials.

 Based on your findings, what future research directions are most critical for optimizing age-specific MST protocols and understanding their underlying neurobiological mechanisms?

 Future research should move beyond fixed, one-size-fits-all protocols toward a more individualized and precision-treatment framework. Large multi-center randomized controlled trials in adolescents are needed to compare MST with optimized standard care and…with ECT, in order to establish relative effectiveness and safety.

At the same time, incorporating neurobiological markers, such as resting-state functional connectivity, EEG measures, and detailed neurocognitive profiling, may help identify predictors of response and developmental moderators. These tools could enable more quantitative and personalized dosing strategies, with stimulation parameters (intensity, frequency, seizure threshold titration, and coil positioning) tailored to each patient’s clinical severity and tolerability.

Wang M, Wang W, Wan S, Zhang H, Lu Y, Jia L. Magnetic seizure therapy for major depressive disorder: age-related differences in efficacy and cognitive side effects. 

Derman C. Magnetic Seizure Therapy Rivals ECT, Protects Cognition in Adolescent MDD. HCPLive. Published on October 16, 2025. Accessed on February 9, 2026. 

https://www.hcplive.com/view/magnetic-seizure-therapy-rivals-ect-protects-cognition-adolescent-mdd

Articles

Adolescents with treatment-resistant MDD treated with standardized MST achieved rapid symptomatic improvement and favorable tolerability versus adults. Across 128 patients, both adolescents and adults demonstrated significant reductions in depressive, anxiety, and broader psychiatric symptoms, sustained through 3 months. Adolescents showed greater early improvement at 72 hours and preserved cognition, whereas adults had transient short-term decrements in delayed recall and executive function and more somatic adverse events. Findings support MST as an effective, cognitively sparing seizure-based neuromodulation option, while underscoring the need for controlled, multi-center comparative trials.

A prospective study finds adolescents with MDD show faster response, fewer cognitive effects, and better tolerability with magnetic seizure therapy than adults.


Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

MST Shows Age-Related Differences in MDD Outcomes, With Lina Jia, MD, PhD

Peter Friedmann, MD, MPH, is a professor of quantitative health sciences at UMass Chan Medical School.

Bringing Hepatitis C Care to Rural Communities Through Mobile Telemedicine

New research is shedding light on the potential utility of a mobile telemedicine-based intervention for hepatitis C virus (HCV) infection among rural persons who inject drugs.

Findings from the randomized clinical trial showed telemedicine integrated with syringe services on a mobile van was associated with improved access to HCV treatment initiation and cure for people with a history of drug injection in rural communities where HCV treatment services are scarce.

High rates of HCV infection among people who inject drugs are well described in urban settings, but far less is known about how to effectively reach affected individuals in rural communities. Additionally, previous work has demonstrated the benefits of embedding infectious disease screening within inpatient substance use disorder programs, highlighting increases in testing uptake and low-barrier delivery of preventive and therapeutic treatment among this vulnerable and difficult-to-reach patient population.

In discussing his team’s work, Peter Friedmann, MD, MPH, a professor of quantitative health sciences at UMass Chan Medical School, explained how a 2-phase research project in northern New England sought to both define the problem and test a potential solution.

“This was in 2019 prior to the pandemic, so telemedicine was considered novel at the time, " Friedmann told 

. “We were interested in whether you could deliver telemedicine from a van, and have the van go out to areas where there was high prevalence of injection use, since injection behavior and hep C sort of go together.”

Previously reported findings from the first phase of the research highlighted high hepatitis C seropositivity rates and prevalence of risky injection behaviors, underscoring the urgent need to improve access to sterile injection supplies, hepatitis C testing, and curative treatment in rural settings.

Friedmann further explained that the first phase revealed significant structural barriers to care, including limited access to phlebotomy and clinicians experienced in hepatitis C management. These gaps directly informed the design of the project’s second phase.

For that phase, he described how the mobile van traveled to areas with high rates of injection drug use, offering harm reduction services alongside telemedicine visits for hepatitis C evaluation and treatment. Participants were randomized either to this intervention or to what he termed “enhanced usual care,” which involved referral to local providers with care navigation support.

Results showed treatment initiation rates were higher in the mobile telemedicine group, with corresponding improvements in cure rates. Friedmann noted that while cure rates were similar among participants who attended their first appointment in either group, the key difference was getting patients started on therapy. Of note, his hypothesis that hepatitis C treatment would reduce syringe-sharing behaviors was not supported.

Friedmann additionally stressed that the success of the mobile model depended on more than the van itself. In his view, having a well-trained, nonjudgmental team experienced in working with this population was critical to supporting treatment initiation and completion in this high-risk, underserved group.

“There are a lot of treatment interruptions in this population, and this population really does require a lot of support in order to initiate and complete treatment,” he said. “Having workers, people are working on the van or working in the setting who are really familiar and comfortable and able to work in sort of a non-stigmatizing, non judgmental way with this population is really critical.”

Editors’ Note: Friedmann reports relevant disclosures with the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) and Indivior.

Friedmann PD, Wilson D, de Gijsel D, et al. Mobile Telemedicine for Treating Chronic Hepatitis C Among Rural People Who Inject Drugs: A Randomized Clinical Trial. 

 2026;9(1):e2555125. doi:10.1001/jamanetworkopen.2025.55125

Brooks A. Infectious Disease Screening in Substance Use Treatment Programs Effective, Study Finds. HCPLive. August 7, 2025. Accessed February 9, 2026. https://www.hcplive.com/view/infectious-disease-screening-in-substance-use-treatment-programs-effective-study-finds

Friedmann describes his research exploring the benefits of mobile telemedicine for HCV infection among persons who inject drugs in rural areas.

Hepatitis C

Hepatitis C page, resources on the topics of medical news and expert insight into HCV can be found. Content includes articles, interviews, videos, podcasts, and breaking news on hepatitis C virus research, treatment, and drug development.

Bringing Hepatitis C Care to Rural Communities Through Mobile Telemedicine, With Peter Friedmann, MD, MPH

Vlado Perkovic is Dean and Scientia Professor of Medicine at UNSW Sydney. He is also a Professorial Fellow at The George Institute and a Staff Specialist in Nephrology at the Royal North Shore Hospital in Sydney.

Inflammation Emerges as Promising CKD Treatment Target, With Vlado Perkovic, MBBS, PhD

Recent trials, including FLOW and SELECT, have reinforced the suggested link between inflammation and chronic kidney disease (CKD) progression.1

Although FLOW was not designed to isolate an inflammatory mechanism, the parallel improvements in C‑reactive protein (CRP), kidney outcomes, and cardiovascular events reinforce inflammation as a plausible, and potentially targetable, facet of CKD management.

“We now know that GLP‑1 receptors are expressed in the kidney, often on immune cells, and in FLOW we saw a roughly 40% reduction in CRP,” explained Vlado Perkovic, MBBS, PhD, provost at the University of New South Wales, in an interview with 

. Taken together, these findings suggest that GLP‑1 receptor agonists have an important anti‑inflammatory effect that may be at least partly independent of their impact on weight loss, which itself would be expected to reduce inflammation. Inflammation clearly appears to be an important part of the story, and newer studies such as the REMODEL trial will help us understand this axis in more detail.”

Since the 1990s, investigators have recognized the central role inflammation plays in the pathogenesis and progression of CKD. Early work focused on monocyte‑derived interleukin‑1 (IL‑1), with investigators proposing IL‑1 release as a key initiating event underlying major complications and increased mortality in patients undergoing dialysis.

Subsequent research has shown an association of persistent low‑grade inflammation with worsened clinical outcomes in CKD, including faster eGFR decline, higher cardiovascular risk, and increased all‑cause mortality. Multiple factors contribute to the inflammatory burden in CKD, including pro‑inflammatory cytokines, oxidative stress and metabolic acidosis, chronic or recurrent infections, altered adipose tissue metabolism, and gut microbiota dysbiosis.

Collectively, these findings, together with the historical burden of inflammation in patients with CKD, have highlighted the reduction of inflammatory markers, such as CRP, as a potential clinical strategy to protect kidney function.

Semaglutide, a GLP-1 receptor agonist, has been associated with reductions in CRP and other inflammatory markers independent of glycemic effects. Potentially supporting this concept, the FLOW study, which evaluated patients with type 2 diabetes and CKD, demonstrated that semaglutide reduced the risk of clinically important kidney outcomes and death from cardiovascular causes. Over a median follow‑up of 3.4 years, investigators randomized 3533 participants to receive either semaglutide (n = 1767) or placebo (n = 1766).

Upon analysis, investigators observed a 24% reduction in the risk of the primary outcome in the semaglutide group compared with placebo (hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.88; 

= .0003). Similar benefits were seen for a composite of the kidney‑specific components of the primary outcome (hazard ratio [HR], 0.79; 95% CI, 0.66 to 0.94) and for death from cardiovascular causes (HR, 0.71; 95% CI, 0.56 to 0.89).

The results for all confirmatory secondary outcomes favored semaglutide: the mean annual eGFR slope was less steep (indicating a slower decline) by 1.16 ml per minute per 1.73 m² in the semaglutide group (

< .001); the risk of major cardiovascular events was 18% lower (HR, 0.82; 95% CI, 0.68 to 0.98; 

 = .029); and the risk of death from any cause was 20% lower (HR, 0.80; 95% CI, 0.67 to 0.95; 

 = 0.01). Serious adverse events occurred in a lower percentage of participants in the semaglutide group than in the placebo group (49.6% vs 53.8%).

“Ongoing trials of other anti‑inflammatory agents, such as interleukin‑6 (IL‑6) receptor antagonists, may also help clarify whether inflammation reduction alone can protect kidney function,” said Perkovic. “Those data could shed light on how much the CRP reductions seen in FLOW contributed to the observed kidney benefits. For now, what we can say is that the mechanism is likely multifactorial and still not fully understood.”

Perkovic also highlighted the SELECT trial, which evaluated semaglutide in patients with obesity but without diabetes. Investigators in SELECT reported improvements in several kidney parameters, including reductions in albuminuria and slower kidney function decline, findings that were broadly consistent with the renal effects observed in FLOW. However, SELECT was not designed to formally test kidney outcomes, he noted.

“This is an important and exciting area for future research. With SGLT2 inhibitors, we saw kidney benefits that were just as robust in people without diabetes as in those with diabetes, suggesting glucose‑independent mechanisms. I suspect we will see something similar with GLP‑1 receptor agonists,” said Perkovic. “Ideally, future trials will demonstrate kidney protection in non‑diabetic chronic kidney disease as well, allowing us to expand the therapeutic toolbox for those patients.”

Editor’s Note: Perkovic reports relevant disclosures with AbbVie, AstraZeneca, Bayer. 

Perkovic V. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. 

New England journal of medicine/The New England journal of medicine

Stenvinkel P, Chertow GM, Devarajan P, et al. Chronic Inflammation in Chronic Kidney Disease Progression: Role of Nrf2. 

https://doi.org/10.1016/j.ekir.2021.04.023

Mihai S, Codrici E, Popescu ID, et al. Inflammation-Related Mechanisms in Chronic Kidney Disease Prediction, Progression, and Outcome. 

Habib Yaribeygi, Maleki M, Tannaz Jamialahmadi, Amirhossein Sahebkar. Anti-inflammatory benefits of semaglutide: State of the art. 

Journal of clinical & translational endocrinology

https://doi.org/10.1016/j.jcte.2024.100340

FLOW/SELECT suggest. GLP-1 receptor agonists may protect kidneys beyond glucose control

Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

Chronic Kidney Disease

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

Positive and statistically significant topline results have been released from a phase 3 clinical study evaluating Ameluz photodynamic therapy (Ameluz PDT) for 

, with the treatment meeting its primary endpoint and showing highly statistically significant superiority versus vehicle gel.

These data were announced on February 9 by Biofrontera Inc. These findings specifically highlight the effectiveness of Ameluz-PDT used alongside the red-light LED RhodoLED platform in the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk.

“Ameluz® PDT is already a valuable treatment option for actinic keratoses on the face and scalp,” Nathalie Zeitouni, MD, professor of dermatology at the University of Arizona College of Medicine and coordinating investigator of this study, said in a statement.

 “Many patients present with lesions on other areas of the body, and these data support the potential for Ameluz® PDT to expand treatment options for physicians and their patients.”

Actinic keratosis is among the most frequently encountered conditions in dermatology, representing a benign intraepidermal proliferation of lesions considered a precancerous and classified as squamous cell carcinoma in situ.

 Around 25% of adults are affected by AK, with prevalence increasing with age.

Ameluz-PDT, a photodynamic therapy option, is currently being evaluated by the US Food and Drug Administration (FDA) following Biofrontera’s submission of a supplemental New Drug Application (sNDA) for superficial basal cell carcinoma (sBCC). The treatment was assessed in a multi-center, randomized, double-blind, vehicle-controlled phase 3 trial, designed to look at both the efficacy and tolerability of field-directed Ameluz PDT compared with vehicle PDT in patients who present with AKs impacting the extremities, neck, and trunk.

There were 172 patients recruited for the analysis, with Zeitouni and coauthors randomizing participants in a 4:1 ratio to be either treated with Ameluz gel or vehicle gel. In their study protocol, the team allowed for treatment of progressively larger field areas, with 1, 2, or 3 tubes of Ameluz applied to regions of approximately 80, 160, or 240 cm², administered either continuously or in discrete patches.

PDT was performed, after application, via either a RhodoLED XL or BF-RhodoLED lamp. All of those assessed were given a single PDT session, with a second treatment provided at the 12-week mark provided residual AK lesions were visible. Those evaluated are still being followed for roughly a year following their final PDT session. The investigators’ main efficacy outcome was the subjects’ complete clearance rate, defined as the proportion of individuals attaining complete clearance of all treated AK lesions 12 weeks post-final PDT treatment.

Overall, the team noted Ameluz-PDT demonstrated superiority over vehicle PDT for the study’s primary endpoint.

 In the Full Analysis Set, complete clearance was shown to have been attained in 45.6% of individuals treated with Ameluz-PDT, compared with 16.7% of those on vehicle PDT, a difference described as highly statistically significant (

Results were consistent in the Per Protocol Set, where complete clearance took place in 53.2% of Ameluz-treated individuals versus 22.2% of vehicle-treated subjects (

 In their secondary analyses, Zeitouni et al further reinforced their data. Overall clearance rates of AK lesions at 12 weeks after the final PDT reached 73.1% in the Full Analysis Set and 80.3% in the Per Protocol Set. When assessed by anatomical site, subject complete clearance rates on the extremities were 38.5% in the Full Analysis Set and 46.5% in the Per Protocol Set, whereas clearance on the neck and trunk was higher, at 74.1% and 78.3%, respectively.

Outside of clinical efficacy, the use of Ameluz-PDT was linked with favorable cosmetic outcomes and strong patient-reported satisfaction in this analysis as well.

 The investigators looked at ratings of the post-therapy appearance of the skin as good or very good in 75.2% of those evaluated. They noted 70.9% of subjects reported comparable assessments. In line with these results, 86.3% of patients stated they would opt for PDT once more if future use was shown to be necessary.

On the basis of these new phase 3 results, Biofrontera has highlighted its plan to submit an sNDA to the FDA during the third quarter of 2026.

Biofrontera Announces Positive Results in Phase 3 Study of Ameluz® PDT for Actinic Keratoses on the Extremities, Neck, and Trunk, Meeting Primary Endpoint. Biofrontera, Inc. February 9, 2026. 

https://www.globenewswire.com/news-release/2026/02/09/3234622/0/en/Biofrontera-Announces-Positive-Results-in-Phase-3-Study-of-Ameluz-PDT-for-Actinic-Keratoses-on-the-Extremities-Neck-and-Trunk-Meeting-Primary-Endpoint.html

Ceryn J, Lesiak A, Narbutt J, et al. Actinic keratosis: comprehensive review of current treatments and emerging therapeutic innovations. Postepy Dermatol Alergol. 2025 Jan 31;42(3):221-231. 

Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDT. Biofrontera Inc. December 2, 2025. Accessed February 9, 2026. 

https://www.globenewswire.com/news-release/2025/12/02/3197970/0/en/Biofrontera-Inc-Announces-Filing-of-Supplemental-New-Drug-Application-sNDA-for-the-Treatment-of-Superficial-Basal-Cell-Carcinoma-sBCC-with-Ameluz-PDT.html

These positive results of Ameluz photodynamic therapy suggest the treatment is effective in actinic keratoses on the neck, trunk, and extremities.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

New Phase 3 Findings Support Ameluz-PDT for Patients with Actinic Keratosis

Shakia Hardy, PhD, MPH, is an associate professor in the department of epidemiology at the University of North Carolina at Chapel Hill.

Hardy discussed the disparity between treatment access and usage, highlighting the fact that most patients are within 10 mmHg of guideline recommendations.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Hypertension

The HCPLive hypertension page is a resource for medical news and expert insights on high blood pressure. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for hypertension, and more.

Most US Adults With Uncontrolled Blood Pressure Not Taking Medication, With Shakia Hardy, PhD, MPH

In their closing remarks, Auchus and DeFronzo emphasize routine screening of high-risk patients, the persistent cardiovascular burden of hypercortisolism despite risk-factor treatment, and the necessity of targeting cortisol excess itself.

Video Series

Special Reports

Final Takeaways: Screening, Cardiovascular Risk, and Treating Cortisol as the Root Cause

Auchus and DeFronzo survey the broader pharmacologic armamentarium for Cushing syndrome and hypercortisolism, including metyrapone, osilodrostat, ketoconazole, levoketoconazole, pasireotide, and investigational agents such as relacorilant and ACTH receptor antagonists.

Beyond Mifepristone: Enzyme Inhibitors, Pituitary-targeted Agents, and Emerging Therapies

DeFronzo and Auchus underscore the magnitude of metabolic benefit with mifepristone, the complexity of managing withdrawal and electrolyte issues, and the importance of specialist support and education for primary care physicians.

Practical Use of Mifepristone and the Need for Endocrinology–Primary Care Collaboration

Auchus and DeFronzo review mifepristone (RU-486) as a glucocorticoid receptor antagonist for Cushing syndrome and refractory hypercortisolism, detailing its effects on glycemic control, weight, and safety considerations from the SEISMIC and CATALYST trials.

Mifepristone in Hypercortisolism: Mechanism, Metabolic Benefits, and Management Challenges

Auchus and DeFronzo use the CATALYST trial to illustrate that both tumor-related and non-neoplastic hypercortisolism are common in refractory diabetes and respond to glucocorticoid receptor blockade, redefining “pseudo-Cushing” as a clinically important disease state.

Non-Neoplastic Hypercortisolism, CATALYST Data, and Expanding the Concept of Cushing Syndrome

Auchus and DeFronzo describe the underuse of hypercortisolism screening in primary care and outline a straightforward, clinically pragmatic approach to the overnight 1-mg dexamethasone suppression test and subsequent workup.

Screening in Primary Care: When and How to Use the Overnight Dexamethasone Suppression Test

In this introductory segment, Richard Auchus, MD, and Ralph DeFronzo, MD, frame hypercortisolism as an underrecognized driver of difficult-to-control type 2 diabetes, hypertension, and osteoporosis, challenging the traditional view of Cushing syndrome as a rare disorder.

Rethinking “Rare” Cushing Syndrome: Hypercortisolism in Difficult-to-Control Diabetes

Frances Lee, MD, is an assistant professor of medicine in the division of liver diseases at Mount Sinai.

Healthcare professionals discuss individualized approaches to second-line therapy for liver disease, considering patient age, fibrosis, and insurance challenges.

How Special Populations and Disease Risk Impact Treatment Assessment in PBC

Experts discuss first-line treatments for Primary Biliary Cholangitis, emphasizing the importance of monitoring and patient compliance for effective management.

Latest News

Why Alcohol Recommendations in the New Dietary Guidelines Fall Short

MST Shows Age-Related Differences in MDD Outcomes, With Lina Jia, MD, PhD

Bringing Hepatitis C Care to Rural Communities Through Mobile Telemedicine, With Peter Friedmann, MD, MPH

Inflammation Emerges as Promising CKD Treatment Target, With Vlado Perkovic, MBBS, PhD

New Phase 3 Findings Support Ameluz-PDT for Patients with Actinic Keratosis