Dupilumab Outperforms Omalizumab in First Head-to-Head Trial for Severe CRSwNP with Asthma: Study

The EVEREST trial directly compared biologics in severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma, and found that dupilumab (Dupixent) was superior to omalizumab (Xolair). At week 24, dupilumab achieved better results across all primary and secondary efficacy endpoints. The findings were published in the recent issue Lancet Respiratory Medicine.

CRSwNP is a chronic inflammatory condition primarily driven by type 2 inflammation, often leading to nasal obstruction, loss of smell, and significant impairment of quality of life. Biologics like dupilumab, which targets interleukin (IL)-4 and IL-13 signaling, and omalizumab, which targets immunoglobulin E (IgE), have each been shown to reduce symptoms. Until now, however, no trial had directly compared their performance.

This phase 4 trial enrolled 360 participants across 17 countries between 2021 and 2024. The patients included were adults with severe, uncontrolled CRSwNP (nasal polyp score ≥5, with congestion and smell loss lasting at least 8 weeks) and physician-diagnosed asthma. They were randomly assigned to receive either dupilumab (300 mg every two weeks) or omalizumab (dose adjusted by weight and IgE levels) for 24 weeks, along with standard mometasone furoate nasal spray.

The main goals of this study were improvement in nasal polyp size, measured endoscopically, and improvement in smell, tested using the University of Pennsylvania Smell Identification Test (UPSIT). Out of 819 screened patients, 360 were enrolled, where 181 received dupilumab and 179 received omalizumab. The participants were predominantly middle-aged (mean age 52 years), with 55% male and 45% female representation.

At 24 weeks, dupilumab outperformed omalizumab across all primary and secondary measures. Patients on dupilumab saw a greater reduction in nasal polyp size, with an average decrease of –1.6 points when compared with omalizumab. Smell recovery was also significantly better, with UPSIT scores improving by an average of 8 points in the dupilumab group versus the omalizumab group. Both results were statistically highly significant (p<0.0001).

When safety was assessed, 64% of dupilumab recipients and 67% of omalizumab recipients reported events. The most frequent were nasopharyngitis, accidental overdose, headache, upper respiratory infections, and cough. No deaths were reported during the trial. Overall, the findings establish dupilumab as a more effective option for patients struggling with severe nasal polyps and asthma, which reinfored its role as a first-choice biologic in type 2 inflammatory respiratory disease.

Source:

De Corso, E., Canonica, G. W., Heffler, E., Springer, M., Grzegorzek, T., Viana, M., Horváth, Z., Mullol, J., Gevaert, P., Michel, J., Peters, A. T., Wagenmann, M., Zaghloul, S., Zhang, M., Corbett, M., Nash, S., Angello, J. T., Radwan, A., Deniz, Y., … Hellings, P. W. (2025). Dupilumab versus omalizumab in patients with chronic rhinosinusitis with nasal polyps and coexisting asthma (EVEREST): a multicentre, randomised, double-blind, head-to-head phase 4 trial. The Lancet. Respiratory Medicine. https://doi.org/10.1016/s2213-2600(25)00287-5

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Patients with Allergies Face Elevated Risk of Developing Optic Neuritis: Study Shows

South Korea: A new large-scale population-based study published in Scientific Reports has identified a noteworthy link between allergic diseases and an increased risk of developing optic neuritis (ON). The research highlights the need for heightened clinical vigilance and further exploration into the shared inflammatory mechanisms connecting allergic and autoimmune diseases.

Drawing data from the Korean National Health Insurance Service (NHIS) database, Jaeryung Kim from the Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea, and colleagues analyzed health records of over 4 million adults aged 20 years and older who underwent health screenings in 2009.
The participants were followed for nearly a decade—up to December 2018 or until they developed ON. Using Cox proportional hazards models, the researchers assessed the risk of ON while accounting for various confounding factors such as age, sex, and comorbidities.
The study revealed the following findings:
  • During a median follow-up of 8.2 years, 3,640 individuals (0.09%) were diagnosed with optic neuritis (ON).
  • Individuals with any allergic disease had a 32% higher risk of developing ON compared to those without allergies (adjusted hazard ratio [aHR] 1.31).
  • Among the allergic conditions studied, allergic rhinitis (AR) showed the strongest association with ON (aHR 1.33).
  • Asthma and atopic dermatitis were not significantly associated with ON risk after adjusting for confounding factors.
The study’s findings point toward possible shared immunopathogenic mechanisms between allergic inflammation and optic nerve inflammation. The researchers propose that chronic allergic inflammation, immune dysregulation, or cytokine-mediated pathways could potentially predispose individuals to autoimmune responses that affect the optic nerve.
Clinically, these findings emphasize the importance of early screening and monitoring for optic neuritis symptoms—such as vision loss, eye pain, or color vision changes—in patients suffering from allergic rhinitis. Prompt detection and intervention may help mitigate vision-related complications in such high-risk populations.
The authors further highlighted that while effective control of allergic symptoms and inflammation may potentially reduce ON risk, more evidence is needed to establish causality. They call for future longitudinal and mechanistic studies to explore inflammatory biomarkers, immune cell dynamics, and genetic predispositions that may underlie this association.
Additionally, the researchers suggest that upcoming investigations should include diverse populations across different regions and ethnicities, as well as examine how allergy treatments influence ON risk and outcomes. Extending research into potential links between allergic disorders and other neurological conditions could also deepen the understanding of overlapping disease mechanisms.
“The large cohort study highlights a significant connection between allergic diseases—especially allergic rhinitis—and an elevated risk of optic neuritis, reinforcing the importance of integrating ophthalmic vigilance into the management of allergic conditions. These insights open new avenues for preventive care and research at the intersection of allergy, immunity, and neuro-ophthalmology,” the authors concluded.
Reference:
Kim, J., Han, K., Jung, J., Oh, S. Y., Park, K., & Min, J. (2025). Analysis of optic neuritis risk in patients with allergic diseases. Scientific Reports, 15(1), 1-9. https://doi.org/10.1038/s41598-025-18088-6

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Prolonged Vaginal Progesterone Use Linked to Higher Gestational Diabetes Risk: Study Shows

Turkey: Researchers have found in a new study that the use of vaginal progesterone may increase the risk of gestational diabetes, especially with longer duration and early initiation in pregnancy, suggesting the need for repeat glucose tolerance testing beyond 24–28 weeks.

The research, published in the Revista da Associação Médica Brasileira, explored whether progesterone prescribed to prevent spontaneous preterm birth could influence the development of gestational diabetes mellitus (GDM). Led by Dr. Ayşe Rabia Kanbak of Bakırçay University’s Gynecology and Obstetrics Clinic in İzmir, Turkey, the team conducted a large cross-sectional analysis to clarify this potential association.
The investigators reviewed data from 3,066 pregnant women aged 18–39 years who underwent a standard 2-hour, 75-gram oral glucose tolerance test (OGTT) between 24 and 28 weeks of gestation. Of these participants, 418 were diagnosed with GDM based on at least one abnormal plasma glucose reading, while 2,648 women with normal glucose levels served as the control group. The two groups were evaluated for factors such as maternal age, parity, pre-pregnancy body mass index, smoking status, gestational age, and use of vaginal progesterone.
The key findings of the study were as follows:
  • Vaginal progesterone use was more frequent in the gestational diabetes group than in the control group (22% vs. 16%).
  • Women who developed gestational diabetes received progesterone for a longer period, averaging nearly 60 days compared with about 52 days in those without the condition.
  • The duration of treatment ranged from 28 to 90 days.
  • Earlier initiation of progesterone appeared to increase further the risk of developing gestational diabetes.
According to the authors, these findings highlight the need for additional vigilance in women prescribed prolonged vaginal progesterone therapy. They recommend that clinicians consider repeating the OGTT after the routine 24–28 week window for patients who begin progesterone early in pregnancy or require extended treatment.
The study’s retrospective design and limited follow-up introduce some caution. Because many patients were ultimately transferred to other hospitals, obtaining complete outcome data was challenging, and the authors note that larger, randomized controlled trials are necessary to confirm their observations and inform clinical protocols.
Despite these limitations, the results point toward a clinically significant relationship between vaginal progesterone and gestational diabetes. As progesterone supplementation remains an important tool for preventing spontaneous preterm birth, the researchers stress that careful glucose monitoring—especially with longer treatment courses—could help reduce potential complications for both mother and baby.
“The study indicates that vaginal progesterone use may raise the risk of gestational diabetes, with longer and earlier treatment further increasing this risk. Patients on prolonged therapy may benefit from an additional oral glucose tolerance test after the routine 24–28-week screening,” the authors concluded.
Reference: https://doi.org/10.1590/1806-9282.20250444

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HPV Infection Linked to Higher Risk of Depression and Bipolar Disorder, Study Finds

Taiwan: A large population-based cohort study has revealed that adults diagnosed with human papillomavirus (HPV) face a significantly higher risk of developing certain psychiatric disorders, particularly major depressive disorder (MDD) and bipolar disorder (BD).

The study, published in the Journal of Medical Virology by Hui-Chin Chang and colleagues from the Evidence-based Medicine Center, Chung Shan Medical University Hospital, Taichung, Taiwan, highlights a critical but often overlooked connection between viral infections and mental health outcomes.
The researchers used data from the TriNetX research network, a large global health database, to assess this relationship. Adults diagnosed with HPV were 1:1 propensity score–matched with non-HPV individuals based on factors such as age, sex, comorbidities, and socioeconomic status.
The study tracked new diagnoses of major depressive disorder, bipolar disorder, and schizophrenia using ICD-10-CM codes. Cox proportional hazard models were employed to estimate hazard ratios, while Kaplan–Meier analyses were conducted to determine cumulative incidence rates over time.
The analysis led to the following findings:
  • Adults aged 18 years and older with an HPV diagnosis had a 28% higher risk of developing major depressive disorder (HR 1.28) compared with those without HPV.
  • The risk of developing bipolar disorder was 31% higher in individuals with HPV (HR 1.31).
  • No significant association was observed between HPV infection and the onset of schizophrenia (HR 1.07).
  • Women, younger adults, and individuals with sleep disorders were more susceptible to developing psychiatric conditions following an HPV diagnosis.
  • These vulnerable subgroups showed stronger associations, indicating that biological, hormonal, or psychosocial factors may contribute to the increased psychiatric risk.
The authors emphasized that while HPV is primarily recognized for its role in causing cervical and other anogenital cancers, the potential neuropsychiatric implications of HPV infection are gaining increasing attention. The exact mechanisms underlying this association remain unclear but could involve immune dysregulation, inflammatory pathways, or stress responses triggered by chronic infection or the psychological burden of diagnosis.
Importantly, the study highlights the need for routine mental health screening and early intervention among individuals diagnosed with HPV, particularly women and those with preexisting vulnerabilities such as sleep disorders. The authors suggest that integrating psychological assessment into HPV care could improve overall health outcomes and quality of life for affected patients.
However, the researchers also noted certain limitations. Being a retrospective study, it could not establish causality, and potential confounding factors such as lifestyle, medication use, or undiagnosed psychiatric conditions could not be entirely ruled out. Despite these constraints, the study’s large sample size and robust analytical methods lend considerable strength to the findings.
The study provides compelling evidence that HPV infection may increase susceptibility to major depressive and bipolar disorders, reinforcing the importance of holistic care that addresses both physical and mental health aspects in individuals living with HPV.
“Further longitudinal and mechanistic studies are warranted to confirm these findings and explore the biological pathways linking HPV to mental health disorders,” the authors concluded.
Reference:
Chang, C., Chu, J., Chang, C., Hsu, T., Hung, H., Su, J., Chen, J., & Gau, Y. (2025). New-Onset Major Depressive Disorder, Schizophrenia and Bipolar Disorder in People With Human Papillomavirus Diagnosis: A Population-Based Cohort Study. Journal of Medical Virology, 97(10), e70618. https://doi.org/10.1002/jmv.70618

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Synthol Injections Identified as Rare Cause of Hypercalcemia: Case report

Poland: A new case report highlights that intramuscular injections of synthol—a site-enhancement oil popular among some bodybuilders—can trigger severe and long-lasting hypercalcemia. The report highlights that routine medical treatments may only provide temporary relief, and surgical removal of the injected material appears to be the only definitive therapy to normalize calcium levels.  

The study, published in BMC Nephrology, was led by Dr. Magdalena Markowska and colleagues from the Department of Internal Diseases, Nephrology and Dialysis at the Military Institute of Medicine—National Research Institute in Warsaw, Poland. They describe a 60-year-old man who developed persistent high calcium levels decades after receiving synthol injections. Despite extensive testing to rule out more common causes of hypercalcemia, such as parathyroid disorders, malignancy, or sarcoidosis, the investigative team traced the source of excess calcium to the old injection sites. Muscle biopsy revealed calcified tissue filled with a silicone-like substance, confirming the long-term impact of synthol on calcium metabolism.
According to the authors, the patient initially presented with weakness, significant weight loss, and acute kidney injury. Laboratory results showed markedly elevated serum calcium and impaired kidney function. Standard interventions—including intravenous fluids, diuretics, steroids, and bisphosphonates—brought only temporary reductions in calcium levels. Imaging studies revealed calcifications in multiple organs, and high-resolution chest scans showed unusual changes in the pectoral muscles. A detailed medical history uncovered that the patient had received intramuscular injections, likely containing synthol, more than thirty years earlier to enhance muscle appearance.
Synthol is composed of approximately 85 percent oil, 7.5 percent lidocaine, and 7.5 percent alcohol. While it is known to cause local complications such as pain, muscle deformities, chronic wounds, and fibrosis soon after injection, delayed systemic effects like hypercalcemia have rarely been documented. Only a handful of similar cases have been reported worldwide. The researchers note that the mechanism is thought to resemble the body’s reaction to free silicone or paraffin oil, in which chronic inflammation and granuloma formation lead to dysregulated vitamin D metabolism and excess calcium release into the bloodstream.
The team emphasized that the patient’s hypercalcemia persisted despite aggressive medical management and recurred after initial improvement. This clinical course supports the conclusion that surgical excision of the affected muscle tissue is the most effective treatment when hypercalcemia arises from synthol deposits.
Dr. Markowska and her colleagues caution that hypercalcemia, if left untreated, can damage multiple organ systems and become life-threatening. They advise clinicians to consider a history of cosmetic or bodybuilding injections when faced with unexplained high calcium levels, even if the injections occurred many years earlier. Prompt recognition of this unusual cause is essential to avoid delays in appropriate treatment and to prevent serious complications.
The authors call for greater awareness of the long-term risks of synthol use, noting that what might initially appear to be a cosmetic procedure can have serious and lasting consequences for metabolic and kidney health.
Reference:
Markowska, M., Romejko, K., Moszyńska, Z. et al. Intramuscular synthol injections cause hypercalcemia in long-term observation: a case report study. BMC Nephrol 26, 476 (2025). https://doi.org/10.1186/s12882-025-04397-5

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MS does not worsen menopause symptoms: study

The largest study of its kind has found menopause is not associated with an increased risk of disability in women with multiple sclerosis (MS).

Until now, the impact of reduced sex hormones on women with MS had only been the subject of small studies, some with conflicting results.

Published in JAMA Neurology, the Monash University-led project assessed whether menopause modified the risk of disability progression for women with relapse-onset MS. It did not.

MS is a chronic autoimmune and neurodegenerative condition, which impacts the immune and nervous systems. It affects three times more women than men and impacts 1 in 800 Australians.

Senior author Associate Professor Vilija Jokubaitis, who is Deputy Head of Monash University’s School of Translational Medicine Department of Neuroscience, said until now, the impact of menopause on MS disease trajectory remained unclear.

“MS disability typically gets worse in both men and women as people age, with a noticeable shift at about the age of 50, which is also around the age of menopause for most women,” Associate Professor Jokubaitis said.

“During perimenopause, the amount of estrogen and progesterone in women fluctuates a lot, before levels of these hormones fall significantly at menopause. In this study we asked whether the loss of sex hormones at menopause could be the reason for MS worsening in women at midlife.

“Previous studies have also looked at this question but have reported conflicting results. These studies have been quite small, reporting on between 74-148 post-menopausal women studied over long periods of time.

“Ours is therefore the largest study of its kind. Our research found that menopause is not associated with an increased risk of disability accumulation in women with MS. Therefore, the increases in disability we see around the age of 50 are not directly due to menopause, but are likely due to other aging processes that affect all people irrespective of sex or gender.”

The study used data from the MSBase Registry, the world’s largest MS clinical outcomes register that follows over 120,000 people with MS around the world and is headquartered in Monash University’s Department of Neuroscience.

It also observed 987 Australian women with MS recruited from eight Australian neuroimmunology-specialist centres, of which 404 (40 per cent) had undergone menopause. They were followed on average for just over 14 years.

“Whilst reproductive ageing may be additive to the effects of somatic ageing, our study does not support menopause as the leading factor for disability progression in older women with MS,” the study found.

First author Dr Francesca Bridge, a neurologist who treats MS patients at Alfred Health, said the results should reassure women with MS undergoing menopause, and their doctors, that it wouldn’t make their MS worse.

“The menopausal transition can be challenging for many women,” Dr Bridge said. “This study gives women with MS one less thing to be concerned about. This study will guide the health/clinical management of women with MS through the menopausal transition.

“The study findings are particularly important for doctors including neurologists, who will now be able to give reassuring advice to their patients that menopause won’t make their MS disability worsen faster.”

Dr Bridge said the menopausal transition was challenging regardless, with symptoms including hot flushes, memory issues, mood disturbance and urinary dysfunction, which could overlap with pre-existing MS-related symptoms.

She said the results would guide clinical conversations around the management of menopause and its symptoms, including lifestyle modifications, and the use of menopausal hormonal therapies (MHT) and non-hormonal therapies to improve quality of life.

“Women with MS will benefit from the holistic management of menopausal symptoms with lifestyle measures such as exercise and maintaining a healthy diet, as well as pharmacological measures such as menopausal hormone therapy (MHT) and non-hormone-based medications to improve their symptoms and quality of life,” she said.

Reference:

Bridge F, Sanfilippo PG, Zhu C, et al. Menopause Impact on Multiple Sclerosis Disability Progression. JAMA Neurol. Published online September 29, 2025. doi:10.1001/jamaneurol.2025.3538

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Artificially sweetened and sugary drinks both associated with increased risk of liver disease, study finds

A major new study reveals that both sugar-sweetened beverages (SSBs) and low- or non-sugar-sweetened beverages (LNSSBs) are significantly associated with a higher risk of developing metabolic dysfunction-associated steatotic liver disease (MASLD).

The study, presented today at UEG Week 2025, followed 123,788 UK Biobank participants without liver disease at baseline. Beverage consumption was assessed using repeated 24-hour dietary questionnaires. Researchers examined the associations between SSB and LNSSB intake and the risks of developing MASLD, liver fat accumulation and liver-related mortality.

A higher intake of both LNSSBs and SSBs (>250g per day) was associated with a 60% (HR: 1.599) and 50% (HR: 1.469) elevated risk of developing MASLD, respectively. Over the median 10.3-year follow-up, 1,178 participants developed MASLD and 108 died from liver-related causes. While no significant association was observed for SSBs, LNSSB consumption was additionally linked to a higher risk of liver-related mortality. Both beverage types were also positively associated with higher liver fat content.

MASLD, formally known as non-alcoholic fatty liver disease (NAFLD), is a condition where fat accumulates in the liver, which overtime can cause inflammation (hepatitis) and symptoms such as pain, fatigue and loss of appetite.2 The disease has emerged as a global health burden since being recognised as the most common chronic liver disease, with experts estimating that it affects over 30% of people worldwide and is a rapidly increasing cause of liver-related deaths.

Lead author of the study, Lihe Liu, commented, “SSBs have long been under scrutiny, while their ‘diet’ alternatives are often seen as the healthier choice. Both, however, are widely consumed and their effects on liver health have not been well understood.”

“Our study shows that LNSSBs were actually linked to a higher risk of MASLD, even at modest intake levels such as a single can per day. These findings challenge the common perception that these drinks are harmless and highlight the need to reconsider their role in diet and liver health, especially as MASLD emerges as a global health concern.”

Liu noted the potential biological mechanisms that may underlie the observed risks, “The higher sugar content in SSBs can cause rapid spikes in blood glucose and insulin, promote weight gain and increase uric acid levels, all of which contribute to liver fat accumulation. LNSSBs, on the other hand, may affect liver health by altering the gut microbiome, disrupting the feeling of fullness, driving sweet cravings and even stimulating insulin secretion.”

The authors emphasised that these findings support limiting both SSBs and LNSSBs as part of a comprehensive prevention strategy, targeting not only liver disease but also cardio-renal-metabolic health. Replacing either beverage with water significantly reduced MASLD risk – by 12.8% for SSBs and 15.2% for LNSSBs – while substitution between the two types of beverages offered no risk reduction.

Liu added, “The safest approach is to limit both sugar-sweetened and artificially sweetened drinks. Water remains the best choice as it removes the metabolic burden and prevents fat accumulation in the liver, whilst hydrating the body.”

The researchers now aim to explore causal mechanisms more deeply through long-term, randomised and genetic trials with a focus on how sugar and its substitutes interact with the gut microbiome and influence liver disease.

Reference:

Artificially sweetened and sugary drinks are both associated with an increased risk of liver disease, study finds, Beyond, Meeting: UEG Week 2025.

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Individualized approach for intra-Articular Injections effective for TMJ Arthralgia, suggests study

Researchers have found in a new study that intra-articular injections are effective for managing temporomandibular joint (TMJ) arthralgia, but no single intervention is consistently superior, emphasizing individualized treatment based on patient needs and preferences. The findings, published in Oral and Maxillofacial Surgery by S.C. Jogigowda, S.P. Shastry, V.S. Christopher, Kamal Kant Kohli and colleagues, highlight the importance of tailoring therapeutic strategies rather than relying on a universal approach. TMJ arthralgia, a common source of orofacial pain, often affects quality of life through impaired chewing, chronic discomfort, and reduced jaw function. By demonstrating that outcomes depend largely on patient-specific factors, the study shifts attention toward shared decision-making and personalized care in dentistry and oral medicine.

The research synthesized evidence from multiple studies evaluating intra-articular injections, including corticosteroids, hyaluronic acid, platelet-rich plasma, and other biologic agents. While each intervention showed effectiveness in reducing pain and improving function, variability in outcomes suggested that the optimal choice depends on individual patient characteristics and clinical context. Mechanistic differences among these injections — from anti-inflammatory action to tissue regeneration and lubrication — provide clinicians with a range of options that can be matched to patient needs. Rather than identifying one best solution, the study stresses the role of patient-centered approaches, where clinical experience and patient preferences are integrated with scientific evidence.

The authors conclude that a one-size-fits-all model is insufficient for TMJ arthralgia and that individualized therapy should guide clinical decision-making. The results encourage clinicians to move beyond standardized protocols and focus on aligning treatments with patient goals, symptom profiles, and risk factors. This study underscores the growing recognition of precision medicine within oral health, extending its influence to musculoskeletal and pain-related conditions. By integrating diverse injection therapies into an individualized framework, clinicians may achieve more sustainable improvements in pain relief and function, ultimately enhancing long-term patient outcomes.

Keywords: TMJ arthralgia, intra-articular injections, temporomandibular joint, pain management, personalized treatment, Oral and Maxillofacial Surgery, Kamal Kant Kohli, S.C. Jogigowda, S.P. Shastry, V.S. Christopher, corticosteroids, hyaluronic acid, platelet-rich plasma

Reference: Jogigowda SC, Shastry SP, Christopher VS, Kohli KK, et al. Intra-articular injections in temporomandibular arthralgia: a systematic review. Oral Maxillofac Surg. 2025;29:155. doi: 10.1007/s10006-025-01448-x
.

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FDA Authorizes ProSense Cryoablation System for Early-Stage Breast Cancer in Older Women

The FDA has granted marketing authorization for the ProSense Cryoablation System by IceCure for the treatment of small, early-stage breast cancer in women aged 70 and above who are not suitable for surgery, offering a minimally invasive care option.

The announcement was made on October 3, 2025, by IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure”, “IceCure Medical” or the “Company”), the developer of minimally invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal.

“We are excited to add a minimally invasive choice around breast cancer treatments and to offer patients an effective, outpatient procedure,” said Eyal Shamir, Chief Executive Officer, IceCure. “With the ProSense® Cryoablation System, we are giving women with low-risk, early-stage breast cancer the choice to freeze their cancer, not their lives, through an effective treatment that minimizes recovery time, and minimal cosmetic changes to the breast.”

ProSense® is the first and only medical device to be granted FDA marketing authorization for the local treatment of breast cancer.

ProSense® is authorized by the FDA for the local treatment of breast cancer in patients ≥70 years of age with biologically low-risk tumors ≤1.5 cm in size and treated with adjuvant endocrine therapy. Biologically low-risk breast cancer is defined as unifocal tumor, size ≤1.5cm, ER+, PR+, HER2-, Ki-67<15% and/or genomic testing indicative of low-risk breast cancer, infiltrating ductal carcinoma (excluding lobular carcinoma, extensive intraductal component, or evidence of lymphovascular invasion), and clinically negative lymph node (N0). The authorized indication includes patients that are not suitable for surgery for breast cancer treatment. For a complete discussion of the benefits and risks of ProSense Cryoablation System for the local treatment of breast cancer, please visit our website.

In granting marketing authorization, the FDA requested that IceCure conduct a post-market surveillance study with the aim of producing additional data in this indication. The post-market study is expected to include approximately 400 patients at 30 sites.

Breast cancer cryoablation with ProSense®, is a simple, quick, out-patient procedure that can have a notably positive impact on the patient experience and can be beneficial for patients seeking more choices.

“You don’t need any kind of cosmetic follow-up, you don’t have a scar, and you don’t have the feeling of having lost part of your breast, because it’s all still there,” said breast cancer patient and ICE3 trial participant, Pam Dixon, when describing her experience with the ProSense® cryoablation procedure. “There was no pain. It was one of the easiest things I’ve ever done. I don’t remember any limitations on my activity.”

During the ProSense® cryoablation procedure, a doctor injects local anesthesia and uses ultrasound imaging to guide a small cryoprobe, a thin hollow needle, into the breast tumor. Once the cryoprobe is placed, liquid nitrogen creates extremely cold temperatures (-170C°) which destroys the breast tumor by creating an ice ball around the targeted tissue. Key advantages of ProSense® cryoablation procedure include:

Maintain breast shape: No tissue is removed and there is minimal scarring from the insertion of the cryoprobe. No breast reconstruction is needed.

Short, out-patient procedure with local anesthesia: Average cryoablation procedure time is approximately 30 – 45 minutes with no hospital waiting or overnight stay. Numbing agents (local anesthesia) are injected only into the area being treated and the ice formed during the procedure has a numbing effect.

Reduced recovery time: Patients typically return to normal activity within 24-hours. Median recovery time is one day with a range of 0 – 8 days.

The procedure is monitored in real-time by ultrasound to ensure the ice ball is growing sufficiently around the tumor, and to avoid damage to the skin or muscle. The doctor may use hydro-dissection to protect the skin or muscle during a procedure depending on the location of the tumor. The tissue destroyed by the ice ball is naturally reabsorbed by the body over time and adjacent tissue is left unharmed.

The FDA’s marketing authorization was based on an abundance of data including IceCure’s ICE3 trial which was published in the Annals of Surgical Oncology. With 194 patients, ICE3 is the largest multi-center clinical trial ever completed for liquid-nitrogen (LN2) based cryoablation for patients aged ≥60 with low-risk, early-stage breast cancer without surgically removing the breast tumor. Only 3.1% of patients with hormone receptor-positive and HER2-breast cancer treated locally with cryoablation and endocrine therapy (also known as hormone or hormonal therapy), experienced local recurrence of breast cancer within 5 years after treatment, based on the study results.

The majority of the cryoablation procedure-related adverse events besides breast cancer recurrence were edema (swelling), bruising, hematoma (bleeding into tissues), skin burn, and postoperative pain. These were mild in severity and all of these events resolved without any permanent effect.

ICE3 study lead author, Richard Fine, MD, FACS, of the West Cancer Center & Research Institute in Germantown, TN and past President of the American Society of Breast Surgeons emphasizes that, “The ICE3 study has proven that cryoablation with ProSense® is a safe, minimally invasive ablative procedure with results similar to that of lumpectomy patients who took endocrine therapy, and has the benefit of being an office-based, non-surgical treatment. Further data coming out of the post-market study should continue to support that cryoablation with ProSense® is a successful option in the de-escalation of breast cancer care in appropriately selected patients.”

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Long-term Steroid Use for Vernal Keratoconjunctivitis Increases Glaucoma Risk: Study

Researchers have found in a new study that the risk of steroid-induced glaucoma increases with steroid use longer than 6 months, higher-potency formulations, and urban living, while even low-potency steroids were associated with ocular hypertension and glaucoma. The study was published in Cureus Journal of Medical Science by Suneeta D. and colleagues.

Vernal keratoconjunctivitis (VKC) is an autoimmune allergic eye condition requiring long-term steroid treatment for symptom control. Although steroids work, unmonitored or prolonged use risks complications such as steroid-induced ocular hypertension (SIOHT) and steroid-induced glaucoma (SIG) leading to irreversible blindness.

Risk factors and clinical distinctions between patient groups must be understood for early detection, proper management, and prevention of blindness. The present multicentric research investigated steroid-related and non-steroid-related factors of glaucoma in patients with VKC, as well as urban–rural differences in presentation and outcomes.

This was a retrospective review of the charts over four centers from April 2019 to March 2020. There were 2,360 patients with VKC included, and their records were reviewed for the use of steroids, clinical features, family history, allergy, refractive errors, and treatment outcomes. Patients were also stratified between urban and rural locations to analyze demographic parameters.

Results

  • Among 2,360 VKC patients, SIOHT and/or SIG developed at 4.7%. Within them, the incidence of SIG was 53.5% and that of SIOHT was 46.5%, presenting at mean ages of 17.1 ± 5.9 years and 16.4 ± 6.0 years, respectively.

  • Topical dexamethasone was used most commonly (50%) among them.

  • Urban regions had greater prevalence of limbal VKC (23%) compared to rural regions (7.9%) (p = 0.01).

  • 29 rural and 11 city patients were found to have a history of allergy, though the difference was not statistically significant (p = 0.1).

  • Steroid use patterns also differed, with more intense usage among urban populations.

  • Steroid withdrawal was adequate in 10.3% of the affected eyes,

  • 62.9% needed anti-glaucoma drugs, and

  • 24.9% needed surgery.

  • Refractive errors also presented, with myopia in 26.5% of SIG/SIOHT eyes and hyperopia in 2.8%.

This multicentric research demonstrates that glaucoma is a significant vision-threatening complication in VKC, and 25% of involved patients need surgery. Urban patients, especially with limbal VKC, seem to be more susceptible, perhaps as a result of environmental exposures. These observations necessitate greater precautions in VKC management, more strict monitoring of steroid treatment, and specialized strategies in urban vs rural populations.

Reference:

Dubey S, Shakya R, Pegu J, et al. (August 13, 2025) Risk Factors Associated With Steroid-Induced Ocular Hypertension and Glaucoma in Patients With Vernal Keratoconjunctivitis in a North Indian Population: A Multicenter Study. Cureus 17(8): e89972. doi:10.7759/cureus.89972

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