Smart contact lens keeps an eye on your eyes-even when they’re closed: Study

A new kind of smart contact lens is poised to revolutionize how we monitor eye health. Designed to work even when the eyes are closed, this stretchable lens combines pressure and movement sensing in one compact, wireless system. It offers a noninvasive, high-resolution way to track key ocular signals like intraocular pressure (IOP) and eye movement (EM)-factors critical for managing chronic conditions such as glaucoma. Successfully tested in both animal and human models, the lens provides accurate, real-time data to external devices without disrupting vision or comfort. This innovation could mark a turning point in how we detect and manage eye diseases.

Vision disorders impact over a billion people worldwide, with glaucoma being one of the most insidious due to its slow, symptomless progression. Key biomarkers like elevated IOP and irregular eye movement (EM) often go unnoticed, especially during sleep, when traditional open-eye instruments fall short. Nocturnal like intraocular pressure (IOP) spikes and rapid eye movement (REM)-related EM events are particularly important for diagnosing and preventing damage. Smart contact lenses have emerged as a promising solution, but most are limited to open-eye use and struggle to capture dual-modal data with precision. Because of these limitations, there’s a growing need for wearable devices that can deliver continuous, closed-eye monitoring with both accuracy and comfort.

Now, researchers from the University of Electronic Science and Technology of China have developed a next-generation smart contact lens that does exactly that. Published (DOI: 10.1038/s41378-025-00946-y) in Microsystems & Nanoengineering in May 2025, the study unveils a soft, stretchable bimodal contact lens (BCL) capable of simultaneously monitoring IOP and EM, even with the eyelids shut. By integrating capacitive and magnetic sensors into a single, wirelessly connected platform, the device enables round-the-clock tracking of eye health, offering a new pathway toward personalized, proactive care.

The BCL combines five layers of carefully engineered materials, including serpentine copper coils for pressure sensing and a neodymium-infused magnetic film for movement detection. This flexible structure allows the lens to contour naturally to the eye, avoiding discomfort and preserving vision. In rabbit models, the lens demonstrated high sensitivity to IOP fluctuations, with resolution as fine as 1 mmHg and superior signal stability even when eyes were closed. EM detection achieved over 97% accuracy in both lab models and human trials, thanks to an integrated glasses-mounted Tesla meter array. Data from the lens are wirelessly relayed to mobile devices, supporting real-time feedback. Importantly, biocompatibility testing confirmed the device is safe for extended wear, with no signs of inflammation or visual disruption. Together, these features present a rare combination of precision, comfort, and practicality for clinical and everyday use.

“This technology bridges a long-standing gap in ophthalmic care,” says Dr. Guang Yao, co-lead author of the study. “The ability to monitor both IOP and EM continuously—even when the eyes are closed-offers a more complete picture of eye health. It enables early intervention and more accurate tracking of disease progression, particularly for glaucoma patients. And because it’s wireless and wearable, it can be used comfortably at home, not just in clinics.”

Beyond glaucoma, this dual-sensing lens could prove useful in monitoring attention-related disorders, neurodegenerative conditions, and even sleep quality through EM patterns. Its wireless integration with mobile devices means patients can share data with physicians remotely, supporting telemedicine and reducing clinical visits. Future versions may incorporate drug delivery features, turning the lens into a closed-loop diagnostic and therapeutic system. With its customizable design and proven safety, the BCL platform opens up new possibilities for smart medical wearables in personalized healthcare.

Reference:

Gan, X., Yao, G., Li, C. et al. Closed-eye intraocular pressure and eye movement monitoring via a stretchable bimodal contact lens. Microsyst Nanoeng 11, 83 (2025). https://doi.org/10.1038/s41378-025-00946-y

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Psoriasis Significantly Increases Risk of Metabolic Syndrome, Especially among those with Severe Disease: Study

Researchers have found in a recent systematic review and meta-analysis that psoriasis is an independent risk factor for metabolic syndrome (MetS), with a pooled prevalence of 26.49% among psoriasis patients. The risk is notably higher in those with more severe disease, as indicated by elevated PASI scores, indicating the role of disease activity in mediating MetS risk.

A study was done to explore the association between psoriasis and metabolic syndrome (MetS) and analyze the impact of disease activity on the risk of MetS occurrence. This systematic review and meta-analysis used computer searches to search for relevant literature on psoriasis and MetS in databases including China National Knowledge Infrastructure (CNKI), PubMed, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL) and Embase. The search period was from the establishment of the database to February 8, 2025. Inclusion in case-control, cohort studies and cross-sectional, with language restrictions in Chinese and English during retrieval. After independent screening of literature, extraction of data, and evaluation of risk bias for inclusion in the study by two evaluators, meta-analysis and subgroup analysis were conducted using Stata17.0 software. Result: A total of 12 studies were analyzed, encompassing 9,641 patients with psoriasis and 2,554 patients suffering from MetS alongside psoriasis. The incidence of metabolic syndrome in psoriasis patients was analyzed and the combined effect size was 26.49% [95% CI (25.61, 27.39%)]. Results from the meta-analysis indicated that, in comparison to the control group, psoriasis patients demonstrated a heightened risk of developing MetS [OR = 1.27, 95% CI (1.21-1.33), p < 0.001]. Subgroup analysis revealed that patients with severe psoriasis (PASI≥10) had a significantly increased risk of developing metabolic syndrome [OR = 2.25 95% CI (1.27, 3.99), p < 0.001], indicating that greater disease activity is associated with an elevated likelihood of MetS occurrence. Psoriasis is positively correlated with MetS risk, and increased disease activity further increases the risk. It is necessary to strengthen screening for metabolic abnormalities and multidisciplinary management.

Reference:

Li Z, Gu Z, Xiang J, Zhang X. The incidence of metabolic syndrome in psoriasis patients and its correlation with disease activity: a systematic review and meta-analysis. Front Med (Lausanne). 2025 May 2;12:1593003. doi: 10.3389/fmed.2025.1593003. PMID: 40385577; PMCID: PMC12081259.

Keywords:

Psoriasis, Significantly, Increases, Risk, Metabolic, Syndrome, Especially, among, those, Severe, Disease, Study, Li Z, Gu Z, Xiang J, Zhang X, disease activity; incidence; meta; metabolic syndrome; psoriasis.

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FDA Approves First Twice-Yearly Injectable PrEP for HIV Prevention

The US Food and Drug Administration has approved lenacapavir (Yeztugo), the first twice-yearly injectable HIV-1 prevention option. As a capsid inhibitor, it offers a significant advancement in PrEP by reducing the burden of daily or bimonthly dosing for adults and adolescents weighing at least 35 kg.

“This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention. Gilead scientists have made it their life’s work to end HIV and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality.”

The first PrEP medication, which was also developed by Gilead, was approved in the U.S. in 2012. However, data from the Centers for Disease Control and Prevention (CDC) show that, in 2022 (the most recent year with available data), only about 1 in 3 (36%) people in the U.S. who met the CDC’s eligibility criteria for PrEP were prescribed a form of PrEP. CDC data show that all populations in the U.S. are not yet using PrEP at rates that could end transmission of the virus at the population level, with particular gaps for women, Black/African American and Hispanic/Latino people, and people in the U.S. South. Data also show that barriers including adherence challenges, stigma and low awareness of existing PrEP options—by both healthcare providers and consumers-contribute to this low uptake of PrEP across multiple populations. The potential impact of this limited uptake, adherence and access is underscored by the fact that, in 2023,more than 100 people were diagnosed with HIV  every day in the U.S.

“Yeztugo could be the transformative PrEP option we’ve been waiting for-offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,” said Carlos del Rio, MD, Distinguished Professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine and Co-Director of the Emory Center for AIDS Research in Atlanta. “A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing.”

FDA approval of Yeztugo is supported by high efficacy and demonstrated safety data in two clinical trials

The FDA approval of Gilead’s New Drug Applications (NDAs) for Yeztugo was supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. In the PURPOSE 1 trial , data at the primary analysis showed twice-yearly subcutaneous Yeztugo demonstrated zero HIV infections among 2,134 participants in the Yeztugo group, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in cisgender women in sub-Saharan Africa. In the PURPOSE 2 trial , there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous Yeztugo group, demonstrating 99.9% of participants in the Yeztugo group did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people. In both trials, Yeztugo also demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified. Data from both trials were published in The New England Journal of Medicine and, based in part on the trial results, in December 2024 the journal Science named lenacapavir its 2024 “Breakthrough of the Year.”

Yeztugo received FDA approval under Priority Review. Additionally, in October 2024, Yeztugo was granted Breakthrough Therapy Designation, which is intended to expedite the development and review of new drugs that may demonstrate substantial improvement over available therapy.

Gilead’s U.S. access strategy for Yeztugo is designed to enable broad uptake and availability for individuals with and without insurance coverage

In the U.S., Gilead is working closely with insurers, healthcare systems and other payers with the goal of ensuring broad insurance coverage for Yeztugo. Additionally, for eligible commercially insured individuals with commercial insurance, Gilead’s Advancing Access® Co-Pay Savings Program will reduce out-of-pocket costs to as little as zero dollars.

Gilead is also committed to helping to ensure that people without insurance in the U.S. will be able to benefit from Yeztugo. For those who are eligible, Gilead’s Advancing Access medication assistance program will provide Yeztugo free of charge.

About Lenacapavir

Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. Lenacapavir is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg who are at risk of HIV acquisition.

The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes.

Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 “Breakthrough of the Year.”

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Lavage-Drainage Approach may Improve Spontaneous esophageal rupture Outcomes: Study

Researchers have found in a new study that the Lavage-Drainage method increased drainage efficiency, lowered inflammation, and improved prognosis in patients with Spontaneous oesophageal rupture. Despite these positive outcomes, the study’s limitations highlight the need for further multi-centre prospective research to refine the treatment and reduce associated costs.

Spontaneous esophageal rupture (SER) is a rare and severe emergency with high mortality, and the treatment algorithm remains controversial. This retrospective study analyzed SER cases that underwent VATS debridement and drainage in Jinling Hospital from January 2014 to July 2024. Patients were divided into Lavage-Drainage and Drainage groups based on whether they received a lavage tube cathetering through the esophageal fistula under gastroscope. Preoperative fluid resuscitation, thoracoscopic mediastinotomy, and thoracic debridement were performed. Post-operative management included fasting, enteral nutrition, anti-infective agents, and fluid and electrolyte balance maintenance. Monitoring indicators included vital signs, laboratory test results, postoperative complications, and other relevant factors. Results: A total of 24 patients were enrolled, with 11 in the Lavage-Drainage group and 13 in the Drainage group. The Lavage-Drainage group had lower 30-day mortality, fewer complications and adverse events, and a faster reduction in inflammatory factors, but a higher cost. There was no significant difference in the length of mechanical ventilation, hospital stay, and ICU stay. The Lavage-Drainage approach enhanced the drainage efficiency, reduced the inflammation level, and improved the prognosis of SER. However, this study has some limitations, and further multi-center prospective studies are needed to optimize the treatment and reduce costs.

Reference:

Huang, Z., Zhao, P., Qiu, B. et al. Effects of the lavage through fistula in treatment of spontaneous esophageal rupture by combined thoracoscopic and gastroscopic management. World J Emerg Surg 20, 51 (2025). https://doi.org/10.1186/s13017-025-00630-6

Keywords:

Lavage-Drainage, Approach, Improve, Spontaneous, esophageal, rupture, Outcomes, Study, Huang, Z., Zhao, P., Qiu, B, Boerhaave’s syndrome, Spontaneous rupture of the esophagus, Gastroscopy, Thoracoscopy, Video-assisted thoracoscopic surgery (VATS)

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Hyperprolactinemia Potentially Linked to Insulin Resistance and Metabolic Dysfunction in PCOS: Study

A new study published in the International Journal of Molecular Sciences showed that hyperprolactinemia may act as a pathophysiological link between obesity, insulin resistance, and impaired carbohydrate metabolism in PCOS patients. Elevated prolactin levels could serve as an additional marker of insulin resistance and potentially worsen it in affected women.

According to the diagnostic criteria used, the prevalence of polycystic ovarian syndrome (PCOS), the most prevalent endocrine condition among women of reproductive age, ranges from 5 to 20%. When two of the three criteria 9chronic anovulation, clinical or laboratory hyperandrogenism, and the existence of polycystic ovaries) are met, PCOS is diagnosed.

Moderate to severe insulin resistance is a hallmark of polycystic ovarian syndrome. In women with PCOS, obesity significantly alters the clinical and laboratory profile. Obesity increases the risk of overt diabetes mellitus in addition to decreasing fertility and worsening insulin resistance.

The prevalence of hyperprolactinemia in women with PCOS described in the literature varies greatly, ranging from less than 5% to more than 65%, due to the many variables that impact both PCOS and hyperprolactinemia. Due to prolactin’s lipogenic properties and impact on the metabolic profile, hyperprolactinemia in PCOS patients may further worsen the loss in insulin sensitivity. Thus, this study by Vesselina Yanachkova and team looked into the prolactin levels in the blood of women with PCOS and how they relate to prediabetes, obesity, and insulin resistance.

The computerized database of 157 women with PCOS diagnoses was used in a retrospective monocentric analysis. After OGTT, measurements were made of serum prolactin, BMI, the full glucose-insulin profile, and insulin resistance indicators. The BMI (p = 0.007), fasting glucose (p = 0.003), insulin levels (p < 0.001), and HOMA-IR (p < 0.001) of the women with hyperprolactinemia (40.8%) were all considerably higher.

Prolactin levels were considerably greater in PCOS women who were classified as overweight/obese (47.1%), insulin resistant (68.8%), having impaired fasting glycemia (28.7%), and prediabetic (36.3%) than in their respective counterparts. Therefore, among women with PCOS, greater prolactin levels were substantially linked to an increased risk of developing overweight/obesity, insulin resistance, and prediabetes.

Overall, the findings suggest that hyperprolactinemia may be a pathophysiological connection between PCOS patients’ obesity, insulin resistance, and abnormalities in their carbohydrate metabolism. In women with polycystic ovary syndrome, elevated prolactin levels might be an additional indicator of insulin resistance.

Source:

Yanachkova, V., & Stankova, T. (2025). Abnormally increased prolactin levels in women with polycystic ovarian syndrome are associated with risk of obesity, insulin resistance and prediabetes. International Journal of Molecular Sciences, 26(9). https://doi.org/10.3390/ijms26094239

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No increased risk of gynecological cancer with testosterone use after five years: Study

Transmasculine and gender-diverse individuals who use testosterone are not at increased risk of gynecological cancer in the first years of hormone therapy. This is evident from large-scale research by Amsterdam UMC, which was published today in eClinicalMedicine. The results provide important insights for healthcare providers and transmasculine and gender-diverse individuals who are considering starting hormone therapy.

Transmasculine and gender-diverse people are registered as women at birth, but do not feel male, non-binary or otherwise at home within the traditional image of being a woman. Many of them choose to use testosterone: a hormone therapy that induces physical changes that are more in line with their gender identity and/or expression.

Researchers at Amsterdam UMC followed 1955 young transmasculine and gender-diverse individuals, who used testosterone for an average of five years. They specifically investigated the risk of cancer of the uterus, ovaries, vagina and vulva during testosterone use.

Asra Vestering, researcher at Amsterdam UMC, explains: “We found no increased risk of these cancers compared to women from the general population. None of these cancers were diagnosed in the entire participant group. This is valuable information for both healthcare providers and transmasculine and gender-diverse people who are considering starting hormone therapy.”

It was also striking that in some of the participants the endometrium was still active, or that signs of ovulation were observed, despite the use of testosterone. Wouter van Vugt, co-researcher at Amsterdam UMC, explains: “This is not only relevant for long-term health, but also means that despite testosterone use, there is still a chance of pregnancy. That is why good gynaecological care and contraceptive care remains essential for this group, even after the start of hormone therapy.”

In recent years, gender registration legislation in the Netherlands has been relaxed, making surgical gender removal no longer a requirement to legally change gender. As a result, more and more transmasculine and gender-diverse people are choosing to start hormone therapy first, without undergoing sex removal surgery (immediately).

Although no definitive conclusions can yet be drawn about the effects of long-term testosterone use, these findings offer reassurance for individuals who have started or want to start testosterone use. Vestering emphasizes: “This research provides important knowledge for better information and guidance of transmasculine and gender-diverse people. At the same time, follow-up research into the effects of long-term testosterone use remains necessary, so that care can be further tailored to safety and quality of life.”

Reference:

Incidence of Gynaecological (Pre-)Malignancies and Endometrial Activity in Transmasculine and Gender Diverse Individuals Using Testosterone: A Retrospective, Single-Centre Cohort Study, eClinicalMedicine (2025).

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Antidepressant withdrawal symptoms more common among long-term users, reveals study

People who have been taking antidepressants for more than two years are substantially more likely to experience withdrawal symptoms compared to short-term users when they come off the medication, finds a new study led by UCL researchers.

Long-term users also tend to experience worse withdrawal symptoms, and for a longer period of time, than short-term users, and are less likely to be able to stop taking the drug when they attempt to do so, according to the findings published in Psychiatry Research.

The study’s lead author Dr Mark Horowitz, visiting clinical researcher at UCL Division of Psychiatry, said: “Our findings confirm what many researchers have long suspected, that the likelihood of experiencing withdrawal symptoms when coming off antidepressants is largely determined by duration of use.

“While coming off antidepressants can be easier for people who have only taken them for a short period of time, these drugs are commonly used for a long time. Half of those in the UK who take antidepressants have taken the medication for at least a year, and the majority of US antidepressants users have been taking them for over two years.”

The study was based on survey responses from 310 participants in England, who had been accessing NHS primary care therapy services, and who had at one point attempted to stop taking their prescribed antidepressant. Most participants – 62% – reported that antidepressants had been helpful to them.

Respondents were asked about an extensive list of potential withdrawal symptoms, and self-reported whether the symptoms were mild, moderate, or severe. Across the whole group, 79% reported at least one withdrawal symptom and 45% experienced symptoms they classified as moderate or severe (30% and 15%, respectively).

Across the entire group, 38% said they were unable to stop antidepressants when they tried to do so, rising to 79% among people who had been taking antidepressants for two years or more.

As some withdrawal symptoms (such as anxiety, worsened mood, agitation and fatigue) overlap with depression and anxiety symptoms and may represent relapse, the researchers also separated those out to find that 76% of respondents experienced at least one non-emotional withdrawal symptom such as dizziness, headache, vertigo, or nausea, while 43% experienced four or more non-emotional symptoms.

In analysis conducted by researchers in the UCL Division of Psychology & Language Sciences, the team found that how long someone had been on an antidepressant was the major determining factor for incidence, severity, and duration of withdrawal effects, and whether someone was able to stop taking the medication. The differences between short-term and long-term users were not explained by the severity of the underlying depression or anxiety disorder.

The researchers found that the odds of experiencing any withdrawal effects were 10 times greater for those who had been on antidepressants for more than two years, compared to those who had been taking them for less than six months.

Among people who had been taking antidepressants for two years of more, 64% reported moderate or severe withdrawal effects (25% reported severe effects), while among those who had been taking the medication for six months or less, the majority (73%) reported either no withdrawal effects or only mild symptoms, with only 7% experiencing severe withdrawal symptoms.

For long-term users, 30% reported withdrawal symptoms lasting more than three months, with 12% experiencing such symptoms for more than a year, while only 10.5% of short-term users experienced withdrawal symptoms for more than three months. For most short-term users, withdrawal symptoms resolved in under four weeks.

Dr Horowitz said: “This is one reason to use antidepressants for no longer than necessary – because doing so may make it harder to stop using them later on.”

The researchers say that one limitation of the study is that the survey response rate was less than one in five (18%). Respondents may have been more motivated to answer the survey if they experienced withdrawal symptoms, although the survey was not solely focused on withdrawal.

While the researchers asked whether people had been easing themselves off antidepressants slowly with a tapering technique, or quitting all at once, the results were inconclusive as not enough participants had been tapering for more than four weeks. The researchers say that as other studies have suggested that tapering is beneficial, further research is needed into how best to taper from antidepressants, and how it can mitigate withdrawal symptoms.

Senior author Professor Joanna Moncrieff (UCL Division of Psychiatry) said: “Withdrawal symptoms are commonly experienced by people coming off antidepressants, so we would advise that people who want to stop taking the medication should do so in consultation with an informed health professional.”

Reference:

Mark A. Horowitz, Joshua E.J. Buckman, Rob Saunders, Elisa Aguirre, James Davies, Joanna Moncrieff, Antidepressants withdrawal effects and duration of use: a survey of patients enrolled in primary care psychotherapy services, Psychiatry Research, 2025, https://doi.org/10.1016/j.psychres.2025.116497.

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Atacicept Significantly Reduces Proteinuria in IgA Nephropathy: Phase 3 Trial Results

Researchers have found in phase 3 ORIGIN 3 trial that investigational dual BAFF/APRIL inhibitor atacicept significantly reduced proteinuria in patients with immunoglobulin A nephropathy (IgAN). The randomized, double-blind, placebo-controlled study involved 431 patients receiving either atacicept 150 mg or placebo weekly via subcutaneous injection.

The primary outcome measured was the change in 24-hour urine protein-to-creatinine ratio (UPCR) at 36 weeks, demonstrating notable improvement with atacicept treatment.

Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001) at week 36. For other prespecified endpoints, atacicept treatment also demonstrated results that were consistent with or better than those previously observed in the ORIGIN Phase 2b trial. The safety profile of atacicept in this analysis was favorable, and comparable to placebo. Vera plans to share these results with the FDA in the coming weeks, and full results will be submitted to the American Society of Nephrology Kidney Week.

“ORIGIN 3 is the first Phase 3 clinical trial in IgAN to demonstrate this magnitude of UPCR reduction compared to placebo at week 36. These results convincingly demonstrate the impact of atacicept to reduce proteinuria,” said Richard Lafayette, M.D., F.A.C.P., Professor of Medicine, Nephrology and Director of the Glomerular Disease Center at Stanford University Medical Center, and a primary investigator for both ORIGIN 2b and ORIGIN 3.

“If approved, we believe that atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor. We currently plan to submit a BLA for atacicept in IgAN to the FDA in the fourth quarter of this year, which may allow for US approval and commercial launch in 2026. We are grateful to the study participants, their families and caregivers, the study investigators and staff, our research partners, and the Vera team for their ongoing commitment and dedication to this important research,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “Vera aspires to evolve the practice of kidney medicine with the hope that, one day, patients may no longer face a future of dialysis or transplantation. Vera is poised for potential commercial launch of atacicept in 2026 and to pursue development in additional indications in other autoimmune kidney diseases and beyond.”

“Patients with IgA nephropathy, as well as their families and care partners, suffer from clinical uncertainty and the horrible outcome of kidney failure. In addition to clinical signs and symptoms, IgAN has a devastating impact on quality of life and mental wellbeing. I’m thrilled with the progress that is being made in developing new treatments for patients,” said Bonnie Schneider, Director and Cofounder of the IgA Nephropathy Foundation.

ORIGIN 3 is an ongoing global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial of 431 adults with IgA nephropathy. Participants were randomized 1:1 to atacicept 150 mg, self-administered at home via once weekly subcutaneous injection, or placebo. The primary efficacy endpoint was the change in 24-hour UPCR compared to placebo at the 36-week interim analysis. The trial continues in a placebo-controlled blinded manner to evaluate the change in kidney function over two years as measured by eGFR and is expected to complete in 2027.

About Atacicept

Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN, other autoimmune kidney diseases and lupus nephritis.

The ORIGIN Phase 2b clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN.

Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical trials across different indications.

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Tau PET Positivity Linked to Higher Risk of Alzheimer’s Progression: JAMA

Researchers have found in a large study that among cognitively unimpaired individuals there was a notable number of positive tau PET scans. When combined with Aβ PET positivity, tau PET positivity was strongly associated with increased risk of clinical progression in both preclinical and symptomatic stages of Alzheimer’s disease (AD). The study highlights tau PET’s potential as a valuable biomarker for staging Alzheimer’s disease pathology.

Tau positron emission tomography (PET) allows in vivo detection of neurofibrillary tangles, a core neuropathologic feature of Alzheimer disease (AD).

A study was done to provide estimates of the frequency of tau PET positivity and its associated risk of clinical outcomes. Longitudinal study using data pooled from 21 cohorts, comprising a convenience sample of 6514 participants from 13 countries, collected between January 2013 and June 2024. Cognitively unimpaired individuals and patients with a clinical diagnosis of mild cognitive impairment (MCI), AD dementia, or other neurodegenerative disorders were included. Tau PET with flortaucipir F 18, amyloid-β (Aβ) PET, and clinical examinations. Tau PET scans were visually rated as positive according to a US Food and Drug Administration– and European Medicines Agency–approved method, designed to indicate the presence of advanced neurofibrillary tangle pathology (Braak stages V-VI). Results Among the 6514 participants (mean age, 69.5 years; 50.5% female), median follow-up time ranged from 1.5 to 4.0 years. Of 3487 cognitively unimpaired participants, 349 (9.8%) were tau PET positive; the estimated frequency of tau PET positivity was less than 1% in those aged younger than 50 years, and increased from 3% (95% CI, 2%-4%) at 60 years to 19% (95% CI, 16%-24%) at 90 years. Tau PET positivity frequency estimates increased across MCI and AD dementia clinical diagnoses (43% [95% CI, 41%-46%] and 79% [95% CI, 77%-82%] at 75 years, respectively). Most tau PET–positive individuals (92%) were also Aβ PET positive. Cognitively unimpaired participants who were positive for both Aβ PET and tau PET had a higher absolute risk of progression to MCI or dementia over the following 5 years (57% [95% CI, 45%-71%]) compared with both Aβ PET–positive/tau PET–negative (17% [95% CI, 13%-22%]) and Aβ PET–negative/tau PET–negative (6% [95% CI, 5%-8%]) individuals. Among participants with MCI at the time of the tau PET scan, an Aβ PET–positive/tau PET–positive profile was associated with a 5-year absolute risk of progression to dementia of 70% (95% CI, 59%-81%). In a large convenience sample, a positive tau PET scan occurred at a nonnegligible rate among cognitively unimpaired individuals, and the combination of Aβ PET positivity and tau PET positivity was associated with a high risk of clinical progression in both preclinical and symptomatic stages of AD. These findings underscore the potential of tau PET as a biomarker for staging AD pathology.

Reference:

Moscoso A, Heeman F, Raghavan S, et al. Frequency and Clinical Outcomes Associated With Tau Positron Emission Tomography Positivity. JAMA. Published online June 16, 2025. doi:10.1001/jama.2025.7817

Keywords:

Tau, PET, Positivity, Linked, Higher Risk, Alzheimer’s , Progression, JAMA , Moscoso A, Heeman F, Raghavan S

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Women who work nightshifts are more likely to have asthma, suggests study

Women who work night shifts are more likely to suffer with moderate or severe asthma compared to women who work in the daytime, according to a study published in ERJ Open Research.

The research, which included more than 270,000 people, found no such link between asthma and working nightshifts in men.

The study was by Dr Robert Maidstone from the University of Manchester, UK, and colleagues. He said: “Asthma disproportionately affects women. Women generally have more severe asthma, and higher rate of hospitalisation and death from asthma compared to men.

“In our previous research we found a higher risk of moderate or severe asthma in nightshift workers, so we wanted to see whether there were further differences between the sexes.”

The researchers used data from the UK Biobank. They included a total of 274,541 working people and found that 5.3% of these had asthma, with 1.9% suffering with moderate or severe asthma (meaning they were taking an asthma preventer inhaler and at least one other asthma treatment, such as an oral steroid). They categorised these people according to whether they worked only during the day, only nightshifts, or a combination of the two.

Their analysis revealed that, overall, women who work shifts are more likely to have asthma. Women who only work nightshifts are around 50% more likely to suffer with moderate or severe asthma compared to women who only work in the daytime.

The risk of asthma in men did not alter according to whether they worked days or nights.

Dr Maidstone said: “This is the first study to evaluate sex differences in the relationship between shift work and asthma. We found that permanent night shift-workers had higher odds of moderate-severe asthma when compared to corresponding day workers.

“This type of research cannot explain why shift work and asthma are linked; however, it could be because shift work disrupts the body clock, including the levels of male and female sex hormones. High testosterone has previously been shown to be protective against asthma, and so lower testosterone in women could play a role. Alternatively, men and women work different types of shift jobs, and this could be a factor.”

In postmenopausal women, the risk of moderate or severe asthma was almost doubled in night workers, compared to day workers, in those not taking hormone replacement therapy (HRT).

Dr Maidstone added: “Our results suggest that HRT might be protective against asthma for nightshift workers, however further research is needed to test this hypothesis in prospective studies and randomised controlled trials.”

The researchers plan to study whether sex hormones play a role in the relationship between shift work and asthma by using data from the UK Biobank and from Our Future Health, a new health research programme in the UK population.

Professor Florence Schleich from the European Respiratory Society’s expert group on airway diseases, asthma, COPD and chronic cough, based at the University of Liège, Belgium, and was not involved in the research. She said: “Asthma is a common, long- term condition that affects millions of people worldwide. We know that women are more likely to have asthma, to have worse asthma and more likely to die from asthma, but we do not fully understand why.

“This research suggests that working nightshifts could be a risk factor for asthma in women, but not in men. The majority of workers will not have an easy option of switching their shift pattern, so we need further research to verify and understand this link and find out what could be done to reduce the risk for women who work shifts.”

Reference:

Robert J. Maidstone, Increased risk of asthma in female night shift workers, ERJ Open Research, https://doi.org/10.1183/23120541.00137-2025 

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