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. doi: 10.5114/ada.2024.147331. PMID: 40672735; PMCID: PMC12262025.

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

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

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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.

Shakia Hardy, PhD, MPH | Image Credit: UNC Gillings School of Global Public Health

 were not taking antihypertensive medication, despite having a systolic blood pressure (SBP) and diastolic blood pressure (DBP) within 10 mmHg of the 2025 American Heart Association/American College of Cardiology (AHA/ACC) goal, according to a recent study.

Investigators utilized data from the National Health and Nutrition Examination Survey (NHANES) 2021-2023 data. The team included patients aged ≥20 years with hypertension, defined as SBP ≥130 mmHg or DBP ≥80 mmHg, or self-reported use of antihypertensive medication. Uncontrolled blood pressure was defined as SBP ≥130 mmHg or DBP ≥80 mmHg.

A total of 3216 patients were included, of whom an estimated 79.1% (95% CI, 77.2-81.1%) had uncontrolled blood pressure. Of these, roughly 61.3% (95% CI, 58.8-63.9%) were not taking antihypertensive medication. Those not taking antihypertensive medication were younger (estimated mean age, 49.2 vs 62.4 years; 

 <.001) and were less likely to have health insurance (88.8% vs 95.1%; 

 <.001), a routine place for health care (83% vs 95.9%; 

Additionally, patients with uncontrolled blood pressure who were taking antihypertensive medication were substantially more likely to have SBP or DBP above goal by ≥10 mmHg (52.6% vs 34.6%; 

For further insight into these data, we spoke with Shakia T. Hardy, PhD, MPH, associate professor in the department of epidemiology at the University of North Carolina at Chapel Hill, in the following Q&A:

 Could you provide a brief overview of your study and its findings?

: We conducted a study that was somewhat motivated by the new 2025 AHA and ACC blood pressure guidelines, and we really wanted to see where the US population was in relation to the new thresholds. So, our study was partially motivated by that, but also by our desire to understand how close people were to that threshold. We often describe blood pressure control in terms of a proportion, but we don't really characterize how far away from that goal people are. So we found that 8 in 10 US adults who had hypertension had uncontrolled blood pressure, and the vast majority of those were not taking antihypertensive medication, and those that were not taking medication were closer to goal. So, we felt like they could easily achieve the treatment goal with the initiation of antihypertensive medication or lifestyle modifications. What I think was most unique about what we found that we didn't necessarily expect was that 80% of those who had blood pressure above goal that were uncontrolled had access to health care. They had health insurance, and they had a regular place to go for care, yet they weren't treated with antihypertensive medications.

 Do you view these findings as a failure of detection, treatment, initiation, intensification, or health system follow-through? Or is it really all of the above?

: I think it's really all of the above. We didn't look at awareness in this study, but oftentimes, once we do, we see that most people are aware. I don't know that it's necessarily a lack of awareness or access to care. I think it is more about the way people are managed within care systems. I think there should be a larger focus, from the clinician standpoint, on initiating medication earlier and titrating medication when people are not reaching blood pressure goals.

 Based on these data, younger adults with uncontrolled blood pressure were much less likely to be treated. How should clinicians rethink hypertension risk communication for patients in their 40s and 50s?

 I think we as a society have come to think of hypertension as a disease of older age, and more recent evidence suggests that hypertension is beginning as early as adolescence for a lot of people, and by middle age, when people are above the threshold. I think the common way of handling that has been to wait and see if blood pressure rises more, as opposed to managing it when it's around the threshold for treatment. From my perspective, I would hope that people were treated earlier, once their blood pressure is consistently above the threshold used for defining hypertension and qualifying people for anti-hypertensive medication.

: Among those already on therapy, a large portion were still ≥10 or ≥20 mmHg above goal. What does this tell us about the need for combination therapy and rapid titration?

 Recent evidence has suggested that a lot of people are still being initiated on monotherapy, even though there's strong evidence that suggests combination therapy is necessary for most people to achieve control. I would hope that titration, whether it's increasing dosage on the medication that people were initiated on or trying combination therapy, would happen earlier in the treatment process than it is currently happening.

 How much of this problem do you believe reflects clinical inertia versus patient-level barriers, such as cost concerns, side effects, or risk perception?

 I don't think it's a cost barrier; anti-protection medications are not that expensive. I do think it might be some patient hesitancy. I've talked to several clinicians who say that their patients are really familiar with the 140/90 threshold for blood pressure, and they're hesitant to bring their blood pressure lower than that. I think part of it might be patient awareness, education, and the desire for their blood pressure to be lower, but I also think part of it is clinical inertia.

 The study highlighted dementia risk as well as cardiovascular risk. Do you believe that framing blood pressure control as “brain protection” might change patient engagement?

 I would hope so. Dementia is a very popular topic right now that people are aware of, and I think it is an outcome that a lot of us fear. I think the risk of dementia being increased with uncontrolled blood pressure might make people rethink whether they want their blood pressure to be lowered. People might be hesitant to take more medications to lower their blood pressure. I think if we emphasize the risk of dementia more, it might convince people that blood pressure lowering is a good thing.

 Which patient populations do you think are the most vulnerable to being left behind by guideline-based hypertension care, and how can future research address that?

 I think it's young adults. There's a lack of evidence for hypertension treatment among the young adult population. And I think because of that, clinicians are hesitant to start young adults on antihypertensives when we don't have the clinical trial data to support it. But then, to look at the long-term implications of that, I am most concerned about the young adult population. In our study, you can see that those who are not on medication were more likely to be younger. I'm most concerned about them being left behind in the long term, and what that means for their cardiovascular disease and dementia risk.

Editor’s Note: Hardy reports no relevant disclosures.

Hardy ST, Jaeger BC, Emanuel E, Muntner P. Blood pressure above goal among US adults with hypertension. JAMA. Published online February 2, 2026. 

Writing Committee Members*, Jones DW, Ferdinand KC, et al. 2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025;152(11):e114-e218. 

NHANES 2021–2023 data indicate that hypertension control remains poor relative to 2025 AHA/ACC targets: ~79% of US adults with hypertension had SBP/DBP ≥130/80. Among those uncontrolled, ~61% were untreated and tended to be younger, less insured, and less connected to routine care, yet most still had healthcare access. Untreated individuals were often within 10 mmHg of goal, suggesting high leverage for early initiation and lifestyle intervention. Treated patients more frequently remained ≥10–30 mmHg above goal, implicating undertitration and insufficient combination therapy.

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

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

Ralph DeFronzo, MD is a Professor of Medicine and Chief, Diabetes Division at UT Health San Antonio.

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.

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

In the concluding segment, Ralph DeFronzo, MD, returns to a central message: hypercortisolism in difficult-to-control type 2 diabetes is substantially more common than many clinicians appreciate. He compares the evolution of thinking around primary aldosteronism—once deemed rare, now recognized as prevalent in resistant hypertension—to the growing recognition of cortisol excess in refractory diabetes. Just as guidelines now recommend screening for primary aldosteronism in resistant hypertension, Dr DeFronzo argues that clinicians should adopt a similar posture toward hypercortisolism in complex diabetic patients, particularly those on advanced therapies such as glucagon-like peptide-1 receptor agonists and tirzepatide who nonetheless remain poorly controlled.

Richard Auchus, MD, underscores that the overnight 1-mg dexamethasone suppression test is inexpensive, technically simple, and well suited to broad use. A single tablet at bedtime and one morning cortisol measurement can identify a meaningful subset of patients—on the order of 1 in 4 in enriched populations—who warrant further evaluation. Rather than viewing this as an additional burden, he frames it as an opportunity: when potent agents such as semaglutide, tirzepatide, and sodium-glucose cotransporter 2 inhibitors fail to normalize glycemia or blood pressure, uncovering hypercortisolism offers a clear, pathophysiologic explanation and a new therapeutic avenue.

Both faculty members close by highlighting that hypercortisolism is not solely a glycemic or blood pressure issue; it is a major driver of atherosclerotic cardiovascular disease, atrial fibrillation, stroke, and myocardial infarction. Dr DeFronzo notes that even when traditional risk factors such as hypertension and dyslipidemia are well treated, cardiovascular risk remains elevated because cortisol exerts direct detrimental effects on the arterial wall, skeletal muscle, skin, and bone quality. Surgical removal of cortisol-producing adenomas or medical blockade of cortisol action is therefore essential to normalize risk. The discussion ends with a call for heightened awareness, systematic screening, and proactive cortisol-directed therapy to improve long-term outcomes in patients with complex metabolic disease.

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Special Reports

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

In this segment, Richard Auchus, MD, broadens the discussion beyond mifepristone to review other medical therapies targeting cortisol synthesis and pituitary drivers of Cushing syndrome. He begins with metyrapone, a relatively weak 11β-hydroxylase inhibitor that has been used off label for many years. Metyrapone requires high total daily doses (often 1–3 g or more) divided three or four times a day, making it more suitable for inpatient settings where rapid titration and close monitoring are feasible. The newer 11β-hydroxylase inhibitor osilodrostat is highlighted as approximately 1000 times more potent, dosed once or twice daily in milligram rather than gram quantities, but with an attendant risk of overtreatment and adrenal insufficiency if not carefully managed—considerations that make endocrinology oversight essential.

Dr Auchus then reviews steroidogenesis inhibitors that have been used chronically, including ketoconazole and levoketoconazole. Ketoconazole, long employed off label for Cushing syndrome, is limited by a black box warning regarding hepatotoxicity and by the risk of QT prolongation. Levoketoconazole, the more potent 2S,4R stereoisomer, allows roughly half the dose and twice-daily rather than three-times-daily dosing, potentially improving tolerability and adherence. For pituitary-dependent Cushing disease, pasireotide—a somatostatin analog targeting somatostatin receptor subtype 5—can be useful, but is ineffective in ACTH-independent forms such as adrenal adenomas, reinforcing the importance of accurate etiologic classification before selecting therapy.

Finally, Ralph DeFronzo, MD, and Dr Auchus discuss emerging and investigational therapies. Relacorilant, a selective glucocorticoid receptor modulator that does not significantly block progesterone receptors, has completed major trials (GRACE and GRADIENT) and may avoid some gynecologic adverse effects seen with mifepristone, such as endometrial thickening and bleeding. Additional pipeline agents include ACTH receptor antagonists (eg, agents targeting melanocortin 2 receptor) for ACTH-dependent disease. Together, these agents expand the therapeutic landscape, providing multiple pharmacologic “Plan A, B, C, and D” options for patients who are not surgical candidates, have persistent or recurrent disease after surgery, or have non-neoplastic hypercortisolism. The segment underscores that, unlike in past decades, clinicians now have a diverse toolkit to tailor therapy to disease etiology, severity, and patient-specific risk profiles.

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

In this segment, Ralph DeFronzo, MD, elaborates on the practical magnitude of benefit observed with mifepristone in hypercortisolism, particularly in patients enrolled in trials like CATALYST. He reiterates that beyond the approximately 1.5–percentage point drop in hemoglobin A1c, patients experienced average weight loss of roughly 5 kg and a 5.1-cm reduction in waist circumference—changes that translate to meaningful alterations in body habitus. From a diabetes-management perspective, such improvements, combined with marked reductions in insulin dose, signal a fundamental shift in the underlying pathophysiology rather than incremental pharmacologic fine-tuning.

However, Dr DeFronzo and Richard Auchus, MD, candidly describe real-world barriers to safe and confident use of mifepristone, particularly in primary care. DeFronzo recounts an early CATALYST patient who developed glucocorticoid withdrawal symptoms, sought care from a primary physician unfamiliar with the trial, and was advised to stop the medication over concerns about adrenal crisis. This anecdote highlights how lack of familiarity with withdrawal phenomena and the expected rise in serum cortisol can lead to premature discontinuation or misinterpretation of adverse effects. Managing hypokalemia via spironolactone and other supportive strategies requires an understanding of the drug’s mechanistic profile and a proactive approach to monitoring.

To address these challenges, the faculty advocate for close collaboration between primary care and endocrinology. Primary care clinicians are best positioned to recognize high-risk patients—those with refractory diabetes and hypertension on multiple agents—whereas endocrinologists bring experience in interpreting hormone tests, managing cortisol-directed therapies, and counseling patients through withdrawal symptoms. Dr DeFronzo notes that manufacturers of mifepristone sponsor support programs that can help guide dosing, monitoring, and side-effect management for clinicians new to the therapy. Collectively, the speakers argue that a team-based model, with clear referral pathways and shared care, is essential to realizing the full potential of mifepristone in broader hypercortisolism management.

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.

Experts Review the First- and Second-Line Treatment Options for PBC

Examine adherence challenges, specialty pharmacy support, and emerging precision medicine approaches in pediatric atopic dermatitis and psoriasis.


Adherence, Specialty Pharmacies, and the Future of Precision Pediatric Care

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

An audio recap of the top 5 stories in healthcare news from the week of 02/01-02/07.

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This Q&A interview with Philip Mease, MD, highlights his contribution to the ‘Psoriasis Update 2026’ talk given at the 2026 Maui Derm Hawaii meeting.

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Spotlighting Updates in Psoriasis, PsA Management in 2026, With Philip Mease, MD

Emily Aman, MPH, from the University of Rochester Medical Center

In an interview, investigators Emily Aman, MPH, and Rachel White highlight why marginalized children with uncontrolled asthma rarely see specialists.

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Latest News

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

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

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

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

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