Zydus Gets CDSCO Panel Nod to Conduct Phase IV Trial for Indacaterol-Budesonide FDC Inhalation

New Delhi: In response to the proposal presented by Zydus Healthcare, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the drug maker to conduct the Phase IV clinical trial of the fixed dose combination (FDC) Indacaterol maleate plus Budesonide Powder for inhalation (capsules).

In addition, the committee recommended the firm to submit the Phase IV clinical trial report of the FDC Indacaterol maleate plus Budesonide Powder for inhalation.

This came after the firm presented the Phase IV clinical trial protocol before the committee.

Indacaterol is a long-acting β2-adrenoceptor agonist and bronchodilator with a rapid onset of action. It was developed by Novartis. It is used to relax bronchial smooth muscle and improve symptoms and airflow obstruction caused by Chronic Obstructive Pulmonary Disease (COPD) and moderate to severe asthma.

Budesonide is a glucocorticoid that acts as an anti-inflammatory and immunomodulator. Budesonide inhalation is a treatment for asthma and chronic obstructive pulmonary disease (COPD).

At the recent SEC meeting, the expert panel reviewed the Phase IV clinical trial protocol before the committee.

After detailed deliberation, the committee recommended for grant of permission to conduct of the Phase IV clinical trial. “Accordingly, the firm should submit the Phase IV clinical trial report to CDSCO for further review by the committee,” the Panel noted.

Also Read: CDSCO Panel Accepts Mylan’s Post-Marketing Surveillance Report for Liposomal Amphotericin B Injection

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Digital Inhalers Improve Asthma Control, May Lower Risk of Severe Exacerbations: Study Shows

Canada: A comprehensive meta-analysis has found that patient-facing digital inhalers may significantly improve asthma management, particularly among individuals who struggle with medication adherence or inhalation techniques. The findings, published in The Journal of Allergy and Clinical Immunology: In Practice, indicate that these devices likely enhance asthma control and could lower the risk of severe asthma exacerbations with minimal associated harm.

Digital inhalers have sensors that provide real-time feedback to patients regarding their medication usage and inhalation technique. These tools aim to address the long-standing issue of poor adherence, estimated to affect around 43% of asthma patients globally.

To better understand their clinical utility, Leonardo Ologundudu, from McMaster University in Ontario, Canada, and colleagues conducted a systematic review of 12 randomized controlled trials involving 2,483 children (ages 4–17) and adults. This work was undertaken in the context of developing new clinical guidelines for severe and difficult-to-control asthma by the American Academy of Allergy, Asthma & Immunology and the American College of Allergy, Asthma, and Immunology Joint Task Force.

Based on the study, the researchers reported the following findings:

  • Digital inhalers likely improve asthma symptom control, with 44.3% of users achieving at least a three-point increase in Asthma Control Test scores, compared to 39.8% in the control group.
  • The study suggests that digital inhalers may reduce the incidence of severe asthma exacerbations, particularly in patients at high risk, with an 11% relative reduction, though the certainty of this finding is low.
  • On average, digital inhalers may result in 45 fewer severe exacerbations per 1,000 patients.
  • The review found minimal harm associated with digital inhalers, with a median device failure rate of about 12%.
  • Technical issues, such as sensor synchronization with smartphones, were the primary cause of failure.
  • One trial reported a case of protected health information exposure, but overall, adverse outcomes were rare.

The authors emphasize considering the benefits of digital inhalers within a broader clinical context. Patients already demonstrating consistent adherence and proper technique may derive limited additional benefit, whereas those requiring ongoing support might find digital inhalers especially helpful.

However, limitations exist. Many studies lacked blinded outcome assessors, and few enrolled older adults above 60. Moreover, the combined effect of digital inhalers and remote clinician monitoring was commonly studied, making it difficult to isolate its standalone impact.

Still, the findings are expected to influence future clinical practice. “These results support the incorporation of digital inhalers into asthma management, particularly for select patient subgroups. Updated guidelines should reflect this evolving landscape,” the researchers concluded.

Reference:

Ologundudu L, Rayner DG, Oppenheimer J, Sumino K, Hoyte F, RiveraSpoljaric K, Perry TT, Nyenhuis SM, Chipps B, Israel E, Shade LE, Press VG, Rangel S, Guyatt GH, McCabe E, O’Byrne PM, Hall L, Orr H, Sue-Wah-Sing D, Melendez A, Winders T, Przywara K, Gardner DD, Rank MA, Bacharier LB, Mosnaim G, Chu DK, Patient-facing digital inhalers for asthma: a systematic review and meta-analysis, The Journal of Allergy and Clinical Immunology: In Practice (2025), doi: https://doi.org/10.1016/j.jaip.2025.04.039.

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Gepotidacin Offers Safe and Effective Oral Alternative for Urogenital Gonorrhoea: Lancet

A new study published in The Lancet journal showed that Gepotidacin was non-inferior to the standard treatment of ceftriaxone plus azithromycin for urogenital Neisseria gonorrhoeae, with no new safety concerns reported. This highlights gepotidacin as a promising novel oral treatment option for uncomplicated urogenital gonorrhoea.

It has been demonstrated that gepotidacin, a first-in-class, bactericidal, triazaacenaphthylene antibiotic that prevents bacterial DNA replication, is both effective and well-tolerated when used to treat simple UTIs. Thus, to assess the safety and effectiveness of gepotidacin for the treatment of uncomplicated urogenital gonorrhea, Jonathan Ross and colleagues carried out this investigation.

This trial compared conventional therapy for uncomplicated urogenital gonorrhea (500 mg IM ceftriaxone + 1 g oral azithromycin) with oral gepotidacin (two 3000 mg doses, 10–12 hours apart). The participants were randomized 1:1, stratified by age, sex, and sexual orientation, and had to be at least 12 years old, weigh more than 45 kg, and have a proven or suspected infection. Microbiological success, or the culture-confirmed eradication of Neisseria gonorrhoeae at days 4–8, was the main endpoint, with a non-inferiority margin of −10%.

All participants randomly assigned to a study treatment who acquired at least one dose of their study treatment and were found to have ceftriaxone-susceptible N. gonorrhoeae isolated from the baseline culture of their urogenital specimen were evaluated for the primary outcome in the microbiological intention-to-treat (micro-ITT) population.

A total of 628 participants were randomized evenly to either ceftriaxone plus azithromycin or gepotidacin from October 2019 to October 2023 and 39% of them were lost to follow-up. There were 406 individuals in the micro-ITT population (204 receiving conventional treatment and 202 receiving gepotidacin).

The majority (92%) were men, and MSM made up a larger percentage (71%) than MSW (20%). 74% were White, 15% were Black/African American, and 17% were Hispanic or Latino. Non-inferiority was demonstrated by the microbiological success rates at test-of-cure, which were 92.6% in the gepotidacin group and 91.2% in the ceftriaxone + azithromycin group.

In neither group did urogenital N. gonorrhoeae persist. Mild to moderate gastrointestinal problems were the most common drug-related side events in the gepotidacin group. Neither group experienced any severe or major adverse effects. Overall, with no new safety issues, gepotidacin showed no inferiority to ceftriaxone with azithromycin for urogenital N. gonorrhoeae, providing a new oral treatment option for simple urogenital gonorrhea.

Source:

Ross, J. D. C., Wilson, J., Workowski, K. A., Taylor, S. N., Lewis, D. A., Gatsi, S., Flight, W., Scangarella-Oman, N. E., Jakielaszek, C., Lythgoe, D., Powell, M., Janmohamed, S., Absalon, J., & Perry, C. (2025). Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study. Lancet, 405(10489), 1608–1620. https://doi.org/10.1016/S0140-6736(25)00628-2

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Vitiligo Linked to Increased Risk of Heart, Autoimmune, and Mental Health Conditions: Study Shows

USA: In a recent case-control study utilizing data from the All of Us research program, researchers have uncovered a broad spectrum of comorbidities linked to vitiligo, extending well beyond its traditionally recognized autoimmune associations. The study, published in Clinical and Experimental Dermatology, was led by Austin J Piontkowski and colleagues from the Department of Dermatology at the Icahn School of Medicine at Mount Sinai, New York.

“The All of Us study revealed that vitiligo patients face significantly higher risks of cardiovascular and autoimmune comorbidities. Notably, they showed increased odds of hyperlipidemia (OR 2.32), atherosclerotic disease (OR 1.78), and hypertension (OR 1.75),” the researchers reported The condition was also linked to bone and joint, endocrine, and psychiatric disorders, highlighting the importance of a comprehensive, multidisciplinary approach to patient care.

Vitiligo, a condition characterized by the loss of skin pigmentation, has long been associated with other autoimmune disorders. However, this new analysis suggests that individuals with vitiligo may also face heightened risks for several systemic health issues.

The researchers examined health data from 1,074 individuals with vitiligo and compared them with 4,296 matched controls. Using conditional logistic regression models, they assessed the odds of developing 29 pre-selected comorbid conditions. P-values were adjusted using the Benjamini-Hochberg method to account for multiple comparisons.

The key findings of the study were as follows:

  • Vitiligo patients showed significantly higher odds of hyperlipidemia (OR 2.32).
  • They had an increased risk of atherosclerotic disease (OR 1.78).
  • The likelihood of developing hypertension was also elevated (OR 1.75).
  • Vitiligo was linked to a higher burden of musculoskeletal conditions.
  • Endocrine disorders were more prevalent among individuals with vitiligo.
  • There was a notable association between vitiligo and autoimmune diseases.
  • Psychiatric conditions were also more common in vitiligo patients.
  • These findings suggest that vitiligo may involve broader systemic health impacts beyond skin depigmentation.

“These results point to the complex and multifaceted nature of vitiligo,” the authors noted, suggesting that systemic inflammation may be a common underlying factor contributing to these associations.

The findings carry important clinical implications. The authors emphasize the need for integrated care strategies with vitiligo patients facing elevated risks for a broad range of comorbidities. Instead of treating vitiligo in isolation, healthcare providers should consider comprehensive management approaches that address co-existing cardiovascular, autoimmune, endocrine, and mental health issues.

The study contributes to a growing body of evidence highlighting the systemic burden of vitiligo and calls for future research into therapeutic options that target both skin symptoms and underlying inflammatory processes.

The large-scale analysis from the All of Us database sheds new light on the health risks individuals face with vitiligo. The findings advocate for a more holistic treatment approach, emphasizing early identification and management of associated conditions to improve overall patient outcomes.

Reference:

Piontkowski, A. J., Dubin, C., Thakker, S., Orloff, J., Powers, C., Silver, C., Ungar, B., & Gulati, N. Vitiligo and associated comorbidities: A case-control study in the All of Us database. Clinical and Experimental Dermatology. https://doi.org/10.1093/ced/llaf228

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Tamsulosin Fails to prevent urinary retention After Inguinal Hernioplasty under spinal anesthesia, suggests study

Researchers have found in a new study that Prophylactic use of tamsulosin did not significantly lower the incidence of postoperative urinary retention (POUR) in patients undergoing inguinal hernioplasty under spinal anesthesia.

Inguinal hernioplasty is a common surgical procedure, often associated with complications such as post-operative urinary retention (POUR). Post-operative urinary retention, characterized by an inability to urinate despite a full bladder following a surgery that may need foley catheterization that on its own can lead to urinary tract infection, stricture, prolonged hospitalization, and increases cost of hospital care. Tamsulosin is a selective alpha-1 adrenergic blocker that can increase urine flow by relaxing the smooth muscle of urethra and prostate, thereby as a less invasive method may be effective in prevention of post-operative urinary retention. This randomized clinical trial involved 179 male participants over 50 undergoing unilateral hernioplasty under spinal anesthesia. Group A (87 subjects) received 0.4 mg Tamsulosin 8 hours before surgery, then 6 to 12 hours post-operatively. Group B (92 subjects) received a placebo on the same schedule. Both were monitored for post-operative urinary retention incidence within 24 hours post-surgery. Data were analyzed using SPSS software version 18 and the P < 0.05 was considered statistically significant. Results: The mean age of participants was 63.37±10.62 years. Post-operative urinary retention requiring catheterization occurred in 10.3% of Group A and 16.3% of Group B. However, the difference was not statistically significant (p=0.242). Logistic regression showed no significant prophylactic effect of Tamsulosin (p=0.171), hypertension (p=0.166), diabetes mellitus (p=0.196), or benign prostatic hyperplasia (p=0.273) on post-operative urinary retention incidence. Prophylactic Tamsulosin did not significantly reduce the incidence of post-operative urinary retention following inguinal hernioplasty under spinal anesthesia.

Reference:

prophylactic effect of Tamsulosin on postoperative urinary retention in Inguinal hernia repair under spinal anesthesia. Seyedinnavadeh, Seyedehatefe et al. The American Journal of Surgery, Volume 0, Issue 0, 116455

Keywords:

Tamsulosin, Fails, prevent, urinary, retention, After, Inguinal, Hernioplasty, under, spinal, anesthesia, suggests, study , Tamsulosin, urinary retention, inguinal hernia, post-operative, The American Journal of Surgery

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Vitamin D increases likelihood that breast cancer will disappear with chemotherapy: Study

A study conducted at the Botucatu School of Medicine at São Paulo State University (FMB-UNESP) in Brazil has shown that low-dose vitamin D supplementation can increase the effectiveness of chemotherapy treatment in women with breast cancer. The results suggest that the substance could be an alternative to hard-to-access drugs that also aim to increase the response to chemotherapy.

The research, supported by FAPESP, involved 80 women over the age of 45 who were about to start treatment at the oncology outpatient clinic of the general and teaching hospital (“Hospital das Clínicas”) at FMB-UNESP. They were separated into two groups: 40 of them took 2,000 IU (international units) of vitamin D a day, while the other 40 received placebo tablets.

After six months of cancer treatment and supplementation, 43% of participants using vitamin D saw their disease disappear with the use of chemotherapy, compared to 24% of the placebo group. All the participants in the study underwent so-called neoadjuvant chemotherapy, which is used to facilitate surgery to remove the tumor.

“Even with a small sample of participants, it was possible to observe a significant difference in the response to chemotherapy. In addition, the dosage used in the research [2,000 IU per day] is far below the target dose for correcting vitamin D deficiency, which is usually 50,000 IU per week,” says Eduardo Carvalho-Pessoa, president of the São Paulo Regional Brazilian Society of Mastology and one of the authors of the article published in the journal Nutrition and Cancer.

Immunity

Vitamin D is a hormone that aids in the absorption of calcium and phosphorus, which is essential for bone health. Recent studies have shown that it also plays an important role in the immune system by helping to fight infections and diseases, including cancer. However, most studies linking cancer and vitamin D supplementation have used high doses of the substance.

This hormone is obtained primarily through exposure to sunlight and food. The recommended daily intake is 600 IU for those who are not deficient in the vitamin, and 800 IU a day for older people. The American Academy of Pediatrics recommends 400 IU of vitamin D per day for babies. It is important to note that too much can be toxic and cause vomiting, weakness, bone pain, and kidney stones.

Most of the participants in the study had low levels of vitamin D, defined as less than 20 nanograms per milliliter (ng/mL) of blood. The Brazilian Society of Rheumatology recommends levels between 40 and 70 ng/mL. “With supplementation, levels increased throughout chemotherapy treatment, which reinforces a possible contribution to the patients’ recovery,” Carvalho-Pessoa told Agência FAPESP. “Vitamin D is an accessible and inexpensive option compared to other drugs used to improve the response to chemotherapy, some of which are not even included in the list of the Unified Health System [the Brazilian national public health network, known as the SUS, its acronym in Portuguese],” he adds.

For the researcher, the findings pave the way for further investigation into the auxiliary role of the substance in the response to cancer treatment. “These are encouraging results that justify a new round of studies with a larger number of participants. This will allow a greater understanding of the role of vitamin D in increasing the response to chemotherapy treatment and, consequently, in the greater likelihood of breast cancer remission,” he concludes.

Reference:

Omodei, M. S., Chimicoviaki, J., Buttros, D. A. B., Almeida-Filho, B. S., Carvalho-Pessoa, C. P., Carvalho-Pessoa, E., … Nahas, E. A. P. (2025). Vitamin D Supplementation Improves Pathological Complete Response in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy: A Randomized Clinical Trial. Nutrition and Cancer, 77(6), 648–657. https://doi.org/10.1080/01635581.2025.2480854

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FDA Approves Clesrovimab to Prevent RSV in Infants

The FDA has approved clesrovimab, marketed as Enflonsia, for the prevention of RSV lower respiratory tract disease in neonates and infants during their first RSV season.

ENFLONSIA is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same 105 mg dose regardless of weight. A typical RSV season usually spans autumn to spring of the next year.

“RSV disease is the leading cause of infant hospitalization in the U.S. and can lead to serious respiratory conditions like bronchiolitis and pneumonia,” said Dr. Octavio Ramilo, chair of the Department of Infectious Diseases at St. Jude Children’s Research Hospital and investigator for the CLEVER (MK-1654-004) and SMART (MK-1654-007) trials. “ENFLONSIA combines dosing convenience with strong clinical data showing significant reductions in RSV disease incidence and hospitalizations, making it a promising new intervention to help protect infants from RSV.”

ENFLONSIA should not be administered to infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA. See additional Selected Safety Information below.

The approval is based on results from the pivotal Phase 2b/3 CLEVER trial (MK-1654-004) evaluating a single dose of ENFLONSIA administered to preterm and full-term infants (birth to 1 year of age). The trial met its primary and key secondary endpoints, as outlined below.

• ENFLONSIA demonstrated a reduction in incidence of RSV-associated medically attended lower respiratory infections (MALRI) requiring ≥1 indicator of lower respiratory infection (LRI) or severity compared to placebo through 5 months (primary endpoint) by 60.5% (95% CI: 44.2, 72.0, p<0.001) (incidence rates: ENFLONSIA, 0.026; placebo, 0.065).

• ENFLONSIA demonstrated a reduction in RSV-associated hospitalizations through 5 months (key secondary endpoint) by 84.3% (95% CI: 66.7, 92.6, p<0.001) (incidence rates: ENFLONSIA, 0.004; placebo, 0.024), showing increasing efficacy with increasing disease severity.

The approval is also supported by results from the Phase 3 SMART trial (MK-1654-007) evaluating the safety and efficacy of ENFLONSIA versus palivizumab in infants at increased risk for severe RSV disease.

“ENFLONSIA provides an important new preventive option to help protect healthy and at-risk infants born during or entering their first RSV season with the same dose regardless of weight,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We are committed to ensuring availability of ENFLONSIA in the U.S. before the start of the upcoming RSV season to help reduce the significant burden of this widespread seasonal infection on families and health care systems.”

The U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for the use of ENFLONSIA in infants. Ordering is anticipated to begin in July, with shipments delivered before the start of the 2025-2026 RSV season.

About ENFLONSIA™ (clesrovimab-cfor)

ENFLONSIA (clesrovimab-cfor) is Merck’s extended half-life monoclonal antibody (mAb) indicated for passive immunization for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season. ENFLONSIA is administered using non-weight-based dosing and is designed to provide direct, rapid and durable protection through 5 months, a typical RSV season. For infants born during the RSV season, ENFLONSIA is to be administered starting from birth. For infants born outside of the RSV season, ENFLONSIA should be administered prior to the start of their first RSV season. For infants undergoing cardiac surgery with cardiopulmonary bypass during or entering their first RSV season, an additional 105 mg dose is recommended as soon as the infant is stable after surgery.

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Cast immobilization effective in treating pediatric medial epicondyle fractures: JAMA

A new study published in the Journal of American Medical Association showed that casting by itself was just as successful as surgery in treating youngsters with medial epicondyle fractures.

A fall on an outstretched hand usually causes medial humeral epicondyle fractures, which account for 12% to 20% of all pediatric elbow fractures and have an incidence of three or more per 100,000 children. With the exception of situations in which the fragment becomes lodged in the elbow joint, when surgery is usually advised, there is presently little agreement on how to treat displaced medial epicondyle fractures in children.

Traditional nonoperative treatment for displaced children’s medial humeral epicondyle fractures involves casting. Nevertheless, even though there is little high-level data to support the benefits of surgery, its usage has expanded. Thus, to ascertain if open surgical reduction and internal fixation, as opposed to extended arm casting, enhance functional outcomes in children with displaced medial humeral epicondyle fractures at 12 months post-injury, Petra Grahn and team carried out this study.

Between August 30, 2019, and August 22, 2023, four university hospitals in Finland participated in this noninferiority randomized clinical study. A 12-month follow-up was finished on August 20, 2024. Children (ages 7–16) with medial humeral epicondyle fractures that were not imprisoned and that had more than 2 mm of displacement were among the participants. Intention to treat served as the foundation for data analysis. The Quick Disabilities of the Arm, Shoulder, and Hand (QDASH) score at 12 months was the main result.

A total of 37 patients (19 [51.4%] female) were randomly assigned to the surgery group, while 35 patients (24 [68.6%] female) were assigned to the cast group. The surgery group’s mean QDASH score at 12 months was 1.73, whereas the cast group’s was 2.71, indicating noninferiority.

There was a statistically significant difference of −8.9 points between the cast group and the other group on the cosmetic visual analog scale. Nearly, 24 out of 35 patients who had cast treatment (68.6%) and 1 out of 37 patients who received surgery (2.7%) experienced nonunion. There were no crossovers from casting to surgery.

Overall, for pediatric patients with displaced humeral medial epicondyle fractures, internal fixation and open reduction were not inferior to casting without reduction. Future research should evaluate long-term results throughout adolescence, especially elbow function under load and late instability, even if this experiment offers compelling evidence for one year.

Source:

Grahn, P., Helenius, I., Hämäläinen, T., Kivisaari, R., Nietosvaara, Y., Sinikumpu, J.-J., Jalkanen, J., Löyttyniemi, E., Ahonen, M., & Finnish Pediatric Orthopedic Study Group Investigators. (2025). Casting vs surgical treatment of children with medial epicondyle fractures: A randomized clinical trial. JAMA Network Open, 8(5), e258479. https://doi.org/10.1001/jamanetworkopen.2025.8479

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Chronic Hepatitis B May Raise Risk of Pre-eclampsia and Eclampsia, Genetic Study Finds

China: A recent study published in the Journal of Obstetrics and Gynaecology has found compelling genetic evidence suggesting that chronic hepatitis B (CHB) infection significantly raises the risk of developing pre-eclampsia and eclampsia during pregnancy. The findings, stemming from a Mendelian randomization (MR) analysis, emphasize the importance of early hepatitis B virus (HBV) screening and personalized maternal care in affected women.

The study was led by Rui Pu and colleagues from Zhejiang University School of Medicine, China. Using genetic data from large-scale population cohorts, the researchers aimed to explore whether a causal relationship exists between CHB infection and hypertensive complications during pregnancy, namely pre-eclampsia, a condition marked by high blood pressure and organ dysfunction, and eclampsia, a severe progression involving seizures.

To investigate this potential link, the team employed a two-sample MR approach, utilizing genome-wide association study (GWAS) summary statistics. CHB-related genetic data were obtained from the UK Biobank involving over 350,000 individuals. The outcome data for pre-eclampsia and eclampsia were drawn from two large Finnish datasets (FinnGen), comprising over 118,000 and 126,000 participants, respectively.

The key findings of the study were as follows:

  • Women with a genetic predisposition to chronic hepatitis B (CHB) infection had a 15% higher risk of developing pre-eclampsia (OR = 1.15).
  • These women also had a 56% higher risk of developing eclampsia (OR = 1.56).
  • The associations were statistically significant.
  • The findings remained consistent across multiple sensitivity analyses, supporting the reliability of the results.

“The study provides genetic support for a causal link between chronic hepatitis B infection and increased susceptibility to pregnancy-related hypertensive disorders,” the authors noted. They further stressed that these findings could have important clinical implications for maternal healthcare, especially in regions with high HBV prevalence.

The research suggests that including hepatitis B status in maternal risk assessments could help identify women at greater risk of developing pre-eclampsia or eclampsia. Early screening for HBV in women of childbearing age and enhanced antenatal surveillance, such as regular monitoring of blood pressure and protein levels in urine, may play a key role in reducing complications.

The authors also advocate for integrating CHB status into future obstetric risk-prediction models. By doing so, healthcare providers can deliver more individualized care plans for pregnant women living with CHB, thereby potentially improving both maternal and fetal outcomes.

As plant-based diets, lifestyle diseases, and viral infections increasingly intersect in global health, this study emphasizes the importance of a multidisciplinary approach to maternal care, one that considers both infectious and genetic risk factors for optimal pregnancy management.

Reference:

Pu, R., Wang, Z., Shang, X., Lu, J., Xu, J., & Xing, Y. (2025). Chronic hepatitis B infection and pre-eclampsia/eclampsia: a Mendelian randomisation study. Journal of Obstetrics and Gynaecology, 45(1). https://doi.org/10.1080/01443615.2025.2500972

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Phentolamine Eye Drops Improve Night Driving Post-Refractive Surgery in Phase 3 trial

Researchers have found in a phase 3 trial that phentolamine ophthalmic solution 0.75% led to significant improvements in mesopic low contrast distance visual acuity and patient-reported night driving ability within 15 days.

The treatment will be available by prescription only.

Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders, announced positive topline results from LYNX-2, a pivotal Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision.

Patients who undergo keratorefractive procedures such as Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), Small-Incision Lenticule Extraction (SMILE) and Radial Keratotomy (RK), often experience vision disturbances including glare, halos and starbursts, due to increased optical aberrations and light scatter under low-light (mesopic), low-contrast conditions.

These disturbances can significantly impair night driving and daily functioning in dim environments. Phentolamine Ophthalmic Solution 0.75% is designed to reduce pupil diameter through a sympatholytic mechanism of action that avoids engaging the ciliary muscle, potentially reducing risks such as retinal tears or detachment associated with older parasympathomimetic agents.

The LYNX-2 study met its primary endpoint of a gain of three lines (or 15 letters) or more of distance vision improvement on a low contrast chart in low light conditions after 15 days of dosing. In the study, 17.3% of patients treated with Phentolamine Ophthalmic Solution 0.75% achieved a ≥15-letter Early Treatment Diabetic Retinopathy Study (ETDRS) (≥ 3-line) improvement in Mesopic Low Contrast Distance Visual Acuity (mLCVA) at Day 15, compared to 9.2% in the placebo group (p<0.05).

“In LYNX-2, Phentolamine Ophthalmic Solution 0.75% delivered a statistically significant primary endpoint. In addition, patient-reported outcome results demonstrated improvements in night-driving vision, enabling patients to function more effectively in low-light, low-contrast conditions,” said George Magrath, MD, CEO, Opus Genetics. “This data builds on earlier results from the LYNX-1 trial and provides evidence of efficacy for this condition, which currently has no FDA-approved therapies. We believe this therapy could address a true unmet need and could offer meaningful benefits to keratorefractive patients experiencing glare, halos, and reduced functional vision in low-light, low-contrast environments.”

“The positive results from the LYNX-2 trial reinforce the potential of Phentolamine Ophthalmic Solution 0.75% as a first-in-class treatment for keratorefractive patients with vison disturbances under low-light conditions,” said Jay Pepose, MD, PhD, Chief Medical Advisor, Opus Genetics. “After just 15 days of treatment, 17% of patients with dysphotopsia following keratorefractive surgery achieved at least 15-letter gain in mesopic low contrast distance vision. Importantly, we also saw functional improvements in difficulty of seeing the road because of oncoming headlights; and difficulty seeing due to glare when driving at dawn or dusk, as reported by patients in the trial.”

LYNX-2 Phase 3 Study

LYNX-2 was a randomized, double-masked, placebo-controlled Phase 3 trial evaluating the safety and efficacy of Phentolamine Ophthalmic Solution 0.75% in 199 patients who had previously undergone keratorefractive surgery and reported decreased visual acuity under mesopic low contrast conditions, and who were randomized to receive either Phentolamine or placebo, self-administered in both eyes, nightly, treated and observed over 6 weeks. The mITT Population includes all randomized patients who received at least one dose of study medication and was used for the primary endpoint analysis and to analyze efficacy endpoints. The trial was conducted under a Special Protocol Assessment (SPA) agreement with the U.S. FDA.

Top-Line Results:

The primary endpoint was defined as the percentage of patients achieving a ≥15-letter ETDRS (≥3-line) improvement in mesopic low contrast distance visual acuity (mLCVA).

17.3% of patients in the Phentolamine arm achieved ≥15-letter ETDRS (≥3-line) gain in mLCVA at Day 15, compared to 9.2% of those receiving placebo (p<0.05).

Patient-reported benefit was observed at Day 15 in difficulty of seeing the road because of oncoming headlights and difficulty seeing due to glare when driving at dawn or dusk, in patients taking Phentolamine Ophthalmic Solution 0.75% compared to placebo (p<0.05) when assessed by the validated Vision and Night Driving Questionnaire (VND-Q).

As per the pre-specified testing, no evidence of tachyphylaxis out to Week 6 of dosing.1

Phentolamine Ophthalmic Solution 0.75% demonstrated a safety profile consistent with previous trials, with no new safety signal identified.

LYNX-2 patients will continue to be monitored for long-term safety over 48 weeks. Additional details on the study design can be found at ClinicalTrials.gov (NCT06349759).

Opus Genetics and Viatris (through its affiliate) are parties to a global licensing agreement which provides for the development of Phentolamine Ophthalmic Solution 0.75% and grants exclusive rights to Viatris to commercialize Phentolamine Ophthalmic Solution 0.75% in the U.S.

1 The study is also designed to examine tachyphylaxis of the therapeutic response to Phentolamine Ophthalmic Solution 0.75% for mLCVA. This was to be achieved by comparing change from Baseline at Week 6 in the Phentolamine Ophthalmic Solution 0.75% group to the best change from baseline achieved during the first month of treatment for mLCVA.

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