New Insight with Dr. Veeral Sheth

Diabetes Dialogue

Don’t Miss a Beat

Crisis Point

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

Chalmers discussed how brensocatib’s potential approval may transform the currently empty treatment landscape for bronchiectasis.

Investigating Brensocatib, Potential First Treatment for Bronchiectasis, with James Chalmers, MBChB, PhD

The FDA has accepted and granted priority review to Insmed’s New Drug Application (NDA) for brensocatib, a potential first treatment for patients with non-cystic fibrosis bronchiectasis. The therapy has a Prescription Drug User Fee Act (PDUFA) of August 12, 2025.

The NDA submission was based on data from the landmark Phase 3 ASPEN study, which met its primary endpoint of clinically and statistically significantly reducing the annualized rate of pulmonary exacerbations compared with placebo over 52 weeks in both its 10 and 25 mg dosages. The study assessed brensocatib 10 mg, brensocatib 25 mg, or placebo once daily for 52 weeks, followed by 4 weeks off treatment, in adults and adolescents.

® spoke with James Chalmers, MBChB, PhD, Professor, Asthma and Lung UK Chair of Respiratory Research, MBChB, PhD, FRCPE, FERS, Clinical Professor (Teaching and Research) of Respiratory Research, Respiratory Medicine and Gastroenterology, University of Dundee, United Kingdom, who served as a primary investigator on the ASPEN study, to learn more about bronchiectasis and its unmet needs in the field. He discussed brensocatib and how it may benefit patients with bronchiectasis as the potential first treatment to be approved for the condition.

“[Bronchiectasis has] been neglected, a bit of a Cinderella condition. In 2011 the European Respiratory Society… described bronchiectasis as the most neglected disease in respiratory medicine, because there's so many patients, but nobody was really doing research into it, and nobody, nobody was doing any clinical trials. And so, it's really exciting that that's now changing, because our patients really need it to change. And this [potential] first licensed therapy is a step towards addressing that major burden,” Chalmers told 

Chalmers shared his excitement for the potential FDA approval of brensocatib and also discussed some priorities in bronchiectasis research and care that will follow after getting a first treatment.

FDA Grants Priority Review to Insmed's Brensocatib for Treatment of Bronchiectasis with PDUFA Target Action Date Set for August 12, 2025. News release. Insmed. February 6, 2025. https://www.prnewswire.com/news-releases/fda-grants-priority-review-to-insmeds-brensocatib-for-treatment-of-bronchiectasis-with-pdufa-target-action-date-set-for-august-12-2025-302369466.html

Videos

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Connor Iapoce is the assistant managing editor for 

joining the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to the movies, and playing with his cat, Squish. You can reach him at 

Aflibercept 8 mg Noninferior for RVO in QUASAR with W. Lloyd Clark, MD

Positive results from the Phase 3 QUASAR trial demonstrate the noninferiority of aflibercept 8 mg (EYLEA HD) administered every 8 weeks to aflibercept 2 mg (EYLEA) dosed every 4 weeks for treating 

macular edema secondary to retinal vein occlusion (RVO)

Announced by Regeneron Pharmaceuticals on February 8, 2025, these findings, presented at Angiogenesis, Exudation, and Degeneration 2025, will support the submission of a supplemental Biologics License Application (sBLA) in Q1 2025.

“A higher concentration of VEGF inhibition might be beneficial because we have seen situations where there’s an unmet need in people with active disease on monthly therapy,” W. Lloyd Clark, MD, Palmetto Retinal Center, and assistant clinical professor of ophthalmology at the University of South Carolina School of Medicine told 

. “One of the key takeaways from QUASAR is that we do see an additional benefit, not only in terms of durability but also efficacy and the ability to get these eyes under control with less frequent injections.”

A common cause of vision loss in adults, RVO is the second most frequent retinal vascular disease, occurring when there is a blockage in a retinal vein, leading to restricted blood flow and increased pressure in the eye. Those with RVO can experience sudden blurry vision or loss of vision, with ultimate serious complications such as macular edema.2

The US Food and Drug Administration approved aflibercept 8 mg for wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy in August 2023.

 QUASAR is a global double-masked, active-controlled Phase 3 trial evaluating the efficacy and safety of aflibercept 8 mg in eyes with macular edema secondary to RVO, including central RVO (CRVO), branch RVO (BRVO), or hemiretinal RVO (HRVO).

Patients were randomized into three groups to receive either aflibercept every 8 weeks after 3 initial monthly doses, aflibercept 8 mg every 8 weeks after 5 initial monthly doses, or aflibercept 2 mg every 4 weeks. The trial’s primary endpoint was the mean change in best-corrected visual acuity (BCVA) through week 36, as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.

An analysis of QUASAR showed the trial met its primary endpoint, with both treatment cohorts of aflibercept 8 mg every 8 weeks achieving non-inferior BCVA gains to aflibercept 2 mg every 4 weeks. These results were consistent across patients with BRVO, CRVO, and HRVO. At 36 weeks, 88% of patients sustained an 8-week aflibercept 8 mg dosing schedule after 3 loading doses, increasing to 93% after 5 loading doses.

Aflibercept 8 mg’s safety remained consistent with the known profile from pivotal trials, including low rates of intraocular inflammation (0.5%). Ocular treatment-emergent adverse events (TEAEs) were reported in ≥5% of all aflibercept 8 mg-treated patients, including increased ocular pressure (5%) and a single case each of endophthalmitis and retinal vasculitis.

“We’ve got ~15 years of clinical experience with the aflibercept molecule for the 2 mg formulation. Now, we’ve got a good body of evidence of 8 mg experience as well, and it appears that the safety profile of the 8 mg formulation is very similar to the 2 mg,” Clark told 

. “Our confidence in the safety of the molecule appears to be pretty much irrespective of the concentration.”

Disclosures: Relevant disclosures for Clark include Amgen, Genentech/Roche, Regeneron, and others.

Eylea HD® (aflibercept) injection 8 mg positive phase 3 results in patients with macular edema following retinal vein occlusion presented at Angiogenesis meeting. Regeneron Pharmaceuticals Inc. February 8, 2025. Accessed February 19, 2025. 

https://newsroom.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-positive-phase-3-results

Blair K, Czyz CN. Central Retinal Vein Occlusion. [Updated 2023 May 1]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK525985/

Campbell P. Aflibercept 8 mg (eylea HD) approved by FDA for wet AMD, DME, and Diabetic retinopathy. HCP Live. August 23, 2023. Accessed February 19, 2025. https://www.hcplive.com/view/aflibercept-8mg-eylea-hd-approved-by-fda-for-wamd-dme-and-diabetic-retinopathy.

Ophthalmology

Ophthalmology page, resources on the topics of medical news and expert insight into ophthalmic disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on eye disease research, treatment, and drug development.

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

Shuai (Steve) Xu, MD, MSc, is a dermatologist, a physician-engineer, Ruth K. Freinkel MD professor at the Feinberg School of Medicine, and the CEO and co-founder of Sibel Health.

Kailas Vodrahalli is a PhD student in electrical engineering at Stanford University.

Harald Kittler, MD, is a professor of dermatology for the Medical University of Vienna.

Artificial Intelligence in Dermatology: Emerging Insights and Diverging Perspectives

AI in Dermatology: Emerging Insights and Diverging Perspectives

Artificial intelligence (AI) technology may be transforming the field of 

, providing clinicians and patients with faster diagnoses, greater diagnostic accuracy, and expanded access to health care. The topic is rapidly becoming one of the most debated in medicine, driven by a heated clash between supporters and skeptics over whether it will truly benefit patients.

A plethora of recent studies have been published regarding new types of AI technology and their use in dermatology. In this 

 feature, 3 speakers were interviewed regarding their contributions to recent AI-related studies in dermatology as well as their more general impressions of the heightened interest in further implementing AI in medicine.

The feature included an interview with Harald Kittler, MD, a professor of dermatology for the Medical University of Vienna, whose international research team had evaluated a learning method in which the accuracy of AI results incorporated human decision-making criteria. The study, which demonstrated a 12% improvement in correct skin cancer diagnoses made by dermatologists, was published in Nature Medicine.

An interview was also conducted with Kailas Vodrahalli, a PhD student in electrical engineering at Stanford University. Vodrahilli touched upon his own team’s research, involving an evaluation of an AI decision support tool using a machine learning algorithm and determining whether the tool could improve the telemedicine-submitted image quality by providing real-time responses to patients. The study concluded that the AI decision support tool’s use, along with their machine learning algorithm, was linked to improvements in the quality of skin disease photographs.

This feature also included an interview with Shuai (Steve) Xu, MD, MSc, a dermatologist, physician engineer, Ruth K. Freinkel MD professor at the Feinberg School of Medicine, and CEO of Sibel Health. His research pointed to the efficacy of the use of haptic feedback on an 

, with occurrences of nocturnal scratching decreasing among adult patients suffering from mild atopic dermatitis.

Kittler, Xu, and Vodrahilli addressed their own findings and discuss the general discourse surrounding AI’s use in dermatology. Each expert’s unique insights, given their differing specialties and backgrounds, allow for an update on new AI research and any current progress AI technology has had in reshaping skin disease detection, clinical decision-making enhancement, and pushing the boundaries of dermatological care.

Check out the feature video posted above to discover more about the findings uncovered by these experts.

Barata C, Rotemberg V, Codella NCF, Tschandl P, Rinner C, Akay BN, Apalla Z, Argenziano G, Halpern A, Lallas A, Longo C, Malvehy J, Puig S, Rosendahl C, Soyer HP, Zalaudek I, Kittler H. A reinforcement learning model for AI-based decision support in skin cancer. Nat Med. 2023 Aug;29(8):1941-1946. doi: 10.1038/s41591-023-02475-5. Epub 2023 Jul 27. PMID: 37501017; PMCID: PMC10427421.

Vodrahalli K, Ko J, Chiou AS, Novoa R, Abid A, Phung M, Yekrang K, Petrone P, Zou J, Daneshjou R. Development and Clinical Evaluation of an Artificial Intelligence Support Tool for Improving Telemedicine Photo Quality. JAMA Dermatol. 2023 May 1;159(5):496-503. doi: 10.1001/jamadermatol.2023.0091. PMID: 36920380; PMCID: PMC10018405.

Yang AF, Patel S, Chun KS, et al. Artificial Intelligence–Enabled Wearable Devices and Nocturnal Scratching in Mild Atopic Dermatitis. JAMA Dermatol. Published online February 05, 2025. doi:10.1001/jamadermatol.2024.5697.

In this feature, 3 experts highlight their own research on new technological advances and their views on the benefits and drawbacks of artificial intelligence in dermatology.

Dermatology

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

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

The role of diet in shaping immune tolerance has become an important area of research in allergy prevention. Emerging evidence suggests that a diverse diet during infancy and early childhood may play a protective role in reducing the risk of developing allergic diseases, including food allergies, asthma, and eczema. The American Academy of Allergy, Asthma & Immunology (AAAAI), American College of Allergy Asthma and Immunology (ACAAI), and Canadian Society of Allergy and Clinical Immunology (CSACI)’s consensus guidance highlights dietary diversity as a crucial factor in the development of immune resilience, recommending the introduction of a broad range of foods early in life to support immune system development.

In addition to introducing common allergens, the guidelines emphasize the importance of varied nutrient sources, exposure to different food groups, and minimizing overly restrictive diets unless medically indicated. Factors such as gut microbiome development, maternal diet during pregnancy and lactation, and environmental influences are also discussed as contributors to allergy risk. 

AAAAI will be holding its 2025 AAAAI/World Allergy Organization (WAO) Joint Congress on February 28-March 3 in San Diego, California. Stay tuned to 

for the latest updates live to you from the meeting.

In this quiz, the second in a series of 3, we will assess your understanding of the evidence supporting dietary diversity, the relationship between nutrition and immune tolerance, and practical strategies for incorporating diversity into early childhood feeding practices.

C. To reduce the risk of developing food allergies

D. To make meal planning easier for parents

Articles

Research indicates that a diverse diet during infancy and early childhood may reduce the risk of allergic diseases. Key organizations emphasize dietary diversity as crucial for immune resilience, recommending early introduction of a broad range of foods. Guidelines also highlight the importance of varied nutrient sources and caution against overly restrictive diets unless necessary. Factors like gut microbiome development, maternal diet, and environmental influences are also considered in allergy risk. The upcoming AAAAI/WAO Joint Congress will provide further insights into these findings.

In this quiz, we test your knowledge of recommendations for introducing dietary diversity to infants.

Quizzes

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Clinical Quiz: Dietary Diversity and Allergy Prevention

Opthea has concluded the final week 52 patient visit in the pivotal Phase 3 COAST trial investigating the superiority and safety of sozinibercept in combination with aflibercept for patients with 

neovascular (wet) age-related macular degeneration (nAMD)

Announced on February 18, 2025, the COAST (Combination OPT-302 with Aflibercept Study) trial is expected to report topline results for sozinibercept for nAMD in early Q2 of this year.

“The completion of the final week 52 patient visit in COAST is an important milestone in the development of sozinibercept, as we deliver on our mission of improving visual outcomes in patients with wet AMD to enable fuller and healthier lives,” said Frederic Guerard, PharmD, Chief Executive Officer of Opthea.

Opthea’s lead product candidate is a first-in-class VEGF-C/D inhibitor being assessed in combination with standard-of-care anti-vascular endothelial growth factor A (VEGF-A) therapies for the treatment of wet AMD. The company indicated that sozinibercept could become the first therapy in nearly two decades to improve visual outcomes in wet AMD in combination with anti-VEGF monotherapies.

COAST is the first of two pivotal Phase 3 trials concurrently evaluating the efficacy and safety of sozinibercept for wet AMD. The ShORe (Study of OPT-302 in combination with Ranibizumab) trial assesses the superiority and safety of sozinibercept in combination with ranibizumab, compared with standard-of-care monotherapy, for wet AMD.

The COAST Trial completed enrollment with 998 treatment-naive patients with nAMD. The trial evaluated sozinibercept every 4 weeks (Q4W) with aflibercept every 8 weeks (Q8W), aflibercept Q8W with sozinibercept Q8W, and aflibercept Q8W plus sham Q4W.

ShORe also completed the enrollment of 986 treatment-naive patients with wet AMD. The trial evaluated ranibizumab Q4W and sozinibercept Q4W, ranibizumab Q4W and sozinibercept Q8W, and ranibizumab Q4W plus sham Q4W.

The primary endpoint for each trial is the mean change in best-corrected visual acuity (BCVA) from baseline to Week 52 for sozinibercept combination therapy, compared with anti-VEGF-A monotherapy. After Week 52, patients will continue to be treated for an additional year to determine the extended safety and tolerability of up to 2 years.

The US Food and Drug Administration (FDA) has previously granted Fast Track Designation to sozinibercept for wet AMD. Opthea indicated the Phase 3 program supports a broad label, and if successful, sozinibercept could be approved for use alongside any anti-VEGF-A therapy in wet AMD.

“I would like to thank Charles Wykoff, MD, PhD, as well as all of the COAST investigators and their clinical staff for their excellent work as we plan to announce the anticipated topline data in early Q2 CY25,” Guerard added.

Opthea completes Coast Final Week 52 patient visit. Opthea Limited, Inc. February 18, 2025. Accessed February 19, 2025. https://ir.opthea.com/news-releases/news-release-details/opthea-completes-coast-final-week-52-patient-visit-0.

Clinical trials. Opthea. July 5, 2024. Accessed February 19, 2025. https://opthea.com/clinical-trials/#phase-3.

Opthea has completed the final patient visit in the Phase 3 COAST trial, evaluating sozinibercept with aflibercept for neovascular age-related macular degeneration (nAMD). The trial aims to improve visual outcomes by combining sozinibercept, a VEGF-C/D inhibitor, with standard anti-VEGF-A therapies. COAST and the concurrent ShORe trial have enrolled nearly 2,000 patients to assess the efficacy and safety of sozinibercept combinations. The primary endpoint is the change in best-corrected visual acuity at Week 52. The FDA has granted Fast Track Designation to sozinibercept for wet AMD.

The first of two Phase 3 pivotal trials investigating sozinibercept, COAST completed its final week 52 visit in patients with wet AMD.

Age-Related Macular Degeneration

age-related macular degeneration condition center page is a comprehensive resource for clinical news and insights on retina disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for patients with AMD.

Sozinibercept Topline Results Expected in Q2 After COAST Trial Completion

Abigail Brooks is an assistant editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Amneal Pharmaceuticals launched mesalamine 800 mg delayed-release tablets for UC and received FDA approval for various lenalidomide doses for blood cancers.

FDA News

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Ulcerative Colitis

Ulcerative Colitis condition center page, resources on the topics of medical news and expert insight into colitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on UC research, treatment, and drug development.

Inflammatory Bowel Disease

On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

Amneal Launches Mesalamine for Ulcerative Colitis, Receives Lenalidomide FDA Approval

This analysis highlights the major risk factors resulting in limited use of oral JAKi for patients with hidradenitis suppurativa, including smoking, obesity, hypertension, and age.

Hidradenitis Suppurativa

Hidradenitis Suppurativa condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatology research, treatment, and drug development.

Major Risk Factors Identified Which May Limit Oral JAK Inhibitor Use in HS

Pitolisant was evaluated for the supplemental indication in the phase 3 INTUNE study, which did not meet its primary outcome of reducing excessive daytime sleepiness.

Sleep

On the HCPLive sleep page, resources on the topics of medical news and expert insight into sleep medicine can be found. Content includes articles, interviews, videos, podcasts, and breaking news on sleep apnea, insomnia, narcolepsy, and more.

FDA Rejects Pitolisant NDA for Idiopathic Hypersomnia

Chemomab completed an end-of-phase 2 meeting with the FDA and has aligned on the design of a phase 3 registration study for nebokitug (CM-101) in PSC.

Hepatology

Cholangitis

cholangitis page, resources on the topics of medical news and expert insight into cholangitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on research, treatment, and drug development in PBC, PSC, and more!

Nebokitug (CM-101) Gets FDA Runway for PSC Approval

HDV RNA-positive patients were more often diagnosed with advanced liver fibrosis and had a 4.7-fold greater risk of severe liver-related outcomes.

Hepatitis C

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

HDV RNA Positivity Linked to Greater Risk of Severe Liver-Related Outcomes

Data from 3 pooled phase 3 studies in children, adolescents, and adults will be presented at the AAAI/WAO Joint Congress.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Ruxolitinib Shows Clinical Benefit in Children, Adults With Atopic Dermatitis

Dual SGLT1/2 inhibition with sotagliflozin significantly reduced both heart attacks and stroke in a prespecified secondary analysis of the SCORED trial.

Cardiology

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

Dyslipidemia

Type 2 Diabetes

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

Atherosclerotic Cardiovascular Disease

Sotagliflozin Cuts MACE Risk By 23% in Patients with Type 2 Diabetes, CKD

Brittany Oliver, MD, FAAD is a board-certified dermatologist practicing in Kansas City, Missouri, with a special interest in pigmentary disorders and hair loss, and a member of the Skin of Color Society.

The February 18, 2025 SOCS News Update highlights SOCS mentorship opportunities as well as the importance of mentors and role models.

Skin of Color Savvy: The Art and Science of Treating Patients of Color

Hosted by Skin of Color Society and produced by HCPLive, 

 delves into the latest research, clinical insights, and culturally competent care practices in dermatology with leading experts. 

Whether it’s groundbreaking research, practice-changing insights, or highlights from the SOCS community, this twice-monthly program provides dermatologists and care providers with expert perspectives on treating patients with skin of color.

Podcasts

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

Alopecia

Skin of Color Savvy: News Update—Addressing Disparities, Black History Month, & Mentorship Opportunities

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

A study found many patients with chronic spontaneous urticaria need add-on or higher-dose therapies, revealing gaps in treatment. Findings will be presented at AAAAI 2025.

Unmet Need for Advanced Chronic Spontaneous Urticaria Treatments Highlighted in Study

Alvotech and Teva expect the review to be completed in the fourth quarter of 2025.

Latest News

Investigating Brensocatib, Potential First Treatment for Bronchiectasis, with James Chalmers, MBChB, PhD

Aflibercept 8 mg Noninferior for RVO in QUASAR with W. Lloyd Clark, MD

AI in Dermatology: Emerging Insights and Diverging Perspectives

Clinical Quiz: Dietary Diversity and Allergy Prevention

Sozinibercept Topline Results Expected in Q2 After COAST Trial Completion