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Revolutionizing Atopic Dermatitis

Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

 has granted accelerated approval to atrasentan (Vanrafia), a once-daily, non-steroidal, oral treatment, for reducing proteinuria in adults with primary 

Announced by Novartis on April 02, 2025, the decision marks the FDA’s first approval for a selective endothelin A receptor antagonist for reducing protein in IgAN—adding to nephrology’s growing armamentarium of therapies. The approval also comes just 12 days after Novartis announced the historic approval of iptacopan (Fabhalta) as the first therapy approval for C3G glomerulopathy.

“Today’s approval marks an important milestone for people living with IgA nephropathy, offering a new option that can be seamlessly integrated into their existing treatment plan, with no REMS requirement,” said Richard Lafayette, MD, professor of medicine in Nephrology and director of the Glomerular Disease Center at Stanford University Medical Center, and Vanrafia ALIGN Study Investigator and Steering Committee Member.

 “Vanrafia is a selective ETA receptor antagonist that effectively reduces proteinuria, a major risk factor in IgAN. Taking early, decisive action is critical to help improve outcomes for these patients who too often progress toward kidney failure.”

According to labeling information, atrasentan can be added to a renin-angiotensin system (RAS) inhibitor with or without a sodium-glucose co-transporter-2 (SGLT2) inhibitor. Additionally, there is no requirement for a Risk Evaluation Mitigation Strategy (REMS) program for use.

The accelerated approval is based on 36-week data from the ongoing ALIGN trial—a global phase 3 study evaluating the efficacy and safety of atrasentan in patients with IgA nephropathy at high risk of kidney function loss. The 132-week trial enrolled 340 patients who received either atrasentan (0.75 mg daily) or placebo alongside their baseline medications, which included maximally tolerated RAS inhibitors and could include SGLT2 inhibitors.


The trial’s primary outcome of interest was the change in urine protein to creatinine ratio (UPCR), based on 24-hour urine collection, from baseline.

Primary results indicated use was associated with a 36.1% (95% CI, -44.6 to -26.4; 

 < .0001) reduction in UPCR at week 36 relative to placebo therapy, with reductions as early as the first 6 weeks of treatment. Data published in the 

detail a geometric mean UPCR of 1450.2 mg/g at baseline to 882.2 mg/g (-38.1%; 95% CI, -43.9 to -31.7) in the atrasentan group. In comparison, the placebo group experienced a reduction from 1484.3 mg/g to 1374.8 mg/g (-3.1%; 95% CI, -12.4 to 7.3).

In the approval announcement, Novartis noted eGFR data are expected in 2026 and intended to support traditional FDA approval.

“We are proud to expand the treatment landscape in IgA nephropathy with today’s FDA accelerated approval of Vanrafia. IgAN is a heterogenous condition that requires differentiated therapies with unique mechanisms of action, and with our multi-asset kidney disease portfolio, we are well positioned to support a broad patient population and advance care for this disease,” said Victor Bultó, president of Novartis US.

Novartis. Novartis receives FDA accelerated approval for Vanrafia® (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy (IgAN). Novartis United States of America. Published April 2, 2025. Accessed April 2, 2025. 

https://www.novartis.com/us-en/news/media-releases/novartis-receives-fda-accelerated-approval-vanrafia-atrasentan-first-and-only-selective-endothelin-receptor-antagonist-proteinuria-reduction-primary-iga-nephropathy-igan

Novartis. Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G). GlobeNewswire. March 20, 2025. Accessed March 20, 2025. 

https://www.globenewswire.com/news-release/2025/03/20/3046800/0/en/Novartis-receives-third-FDA-approval-for-oral-Fabhalta-iptacopan-the-first-and-only-treatment-approved-in-C3-glomerulopathy-C3G.html

Heerspink HJL, Jardine M, Kohan DE, et al. Atrasentan in Patients with IgA Nephropathy. 

Articles

The FDA has granted accelerated approval to atrasentan (Vanrafia), a selective endothelin A receptor antagonist, for reducing proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression. This approval, announced by Novartis, marks a significant milestone in nephrology, offering a new treatment option without the need for a REMS program. The decision is based on promising 36-week data from the ALIGN trial, which demonstrated a significant reduction in urine protein to creatinine ratio (UPCR) compared to placebo, with further eGFR data expected in 2026.

The approval indicates Novartis's atrasentan (Vanrafia) for proteinuria reduction in primary IgA nephropathy.

News

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IgA Nephropathy

The HCPLive Berger disease page is a resource for medical news and expert insights on IgA nephropathy. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in Berger disease, and more.

Nephrology

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

FDA News

Atrasentan (Vanrafia) Receives Accelerated Approval in IgA Nephropathy

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Frederic Guerard, PharmD | Image Credit: Linkedin

Sozinibercept, a novel vascular endothelial growth factor (VEGF) “trap” fusion protein intended for use treating wet 

, failed to demonstrate the vision improvements required for success in the phase 3 Combination of OPT-302 with Aflibercept Study (COAST) trial. 

According to a March 31, 2025, press release from Opthea, the company and have decided to terminate both the COAST and Study of OPT-302 in combination with Ranibizumab (ShORe) trials, as well as ceasing development of sozinibercept in wet AMD.

In July of 2021, Opthea was granted Fast Track Designation by the US Food and Drug Administration, who highlighted sozinibercept’s potential to address unmet need in AMD treatment. Opthea quickly enacted the initial COAST Phase 3 trial; however, on March 24, 2025, the company announced that COAST had failed to achieve its primary endpoint for mean change in best-corrected visual acuity (BCVA) against aflibercept monotherapy.

After the failure of the COAST trial, Opthea decided to accelerate the topline data readout of the ShORe trial. The trial aimed to evaluate the efficacy of administering 2 mg sozinibercept intravenously at 4 week (Q4W) or 8 week (Q8W) intervals, combined with 0.5 mg ranibizumab Q4W. This would be contrasted against 0.5 mg ranibizumab monotherapy. However, the trial failed to meet its primary endpoint of mean change in best corrected visual acuity (BCVA) by week 52.

Patients with wet AMD who received combination therapy Q4W (n = 301) or Q8W (n = 301) exhibited mean change of 13.3 and 12.9 letters from baseline to week 52 respectively (

 = .35). Ranibizumab monotherapy recipients (n = 299) exhibited a mean change of 14.2 letters (

 = .19). Among the overall population, combination therapy recipients at Q4W (n = 328) and Q8W (n = 326) achieved a mean change of 13.3 and 12.6 letters from baseline respectively (

 = .032). Ranibizumab monotherapy recipients (n = 331) exhibited a 14.3 letter change (

Additionally, with the closure of the COAST and ShORe trials, Opthea has expressed concern for its future. The company is estimated to have unaudited cash and cash equivalents of US$100M as of the end of March. Discussions with the DFA Investors are ongoing

“We are disappointed that COAST and ShORe did not demonstrate the improvements in vision with sozinibercept combination therapy compared to standard of care that we had hoped for,” said Frederic Guerard, PharmD, CEO of Opthea. “We are grateful to all patients, clinical investigators and their staff around the world who participated in the sozinibercept Phase 3 clinical program, and for their contributions in investigating new treatments for wet AMD.”

Opthea announces decision to discontinue wet AMD trials. Opthea Limited. Published online March 31, 2025. Accessed April 2, 2025. 

https://ir.opthea.com/news-releases/news-release-details/opthea-announces-decision-discontinue-wet-amd-trials-0

Opthea announces Coast Phase 3 trial Topline Results. Opthea Limited. March 24, 2025. Accessed April 02, 2025. 

https://ir.opthea.com/news-releases/news-release-details/opthea-announces-coast-phase-3-trial-topline-results

Opthea's novel VEGF "trap" fusion protein, sozinibercept, failed to meet vision improvement benchmarks in the COAST and ShORe phase 3 trials for wet AMD. Consequently, Opthea has terminated these trials and ceased sozinibercept's development. Despite receiving Fast Track Designation from the FDA in 2021, the trials did not achieve the primary endpoint of mean change in best-corrected visual acuity. Opthea now faces financial uncertainty, with ongoing discussions with investors, and has expressed gratitude to participants and investigators involved in the trials.

The treatment for wet age-related macular degeneration failed to achieve its primary endpoint in both trials.

Clinical Trial Insights

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.

Opthea Announces Termination of ShORe and COAST Trials of Sozinibercept

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

March brought significant advancements in rheumatology, spanning gout, psoriatic arthritis (PsA), and fibromyalgia. In gout, SAP-001 from Shanton Pharma showed best-in-class efficacy in a phase 2b trial, with most patients achieving target uric acid levels by month three. XORTX continued its discussions with the FDA on oxypurinol-based XORLO, a potential new treatment for hyperuricemia. Meanwhile, new epidemiological data linked tuberculosis to a 42% increased risk of gout, likely due to medication-induced disruptions in uric acid metabolism.

In PsA, the POETYK PsA-2 trial reinforced the benefits of deucravacitinib, a TYK2 inhibitor, in reducing symptoms and improving quality of life, even among patients with prior TNF inhibitor exposure. A separate analysis found comparable cardiovascular safety across biologics like ustekinumab, adalimumab, etanercept, and secukinumab, providing reassurance on long-term treatment risks.

Fibromyalgia research explored nontraditional therapies, including select Cannabis sativa terpenes such as geraniol and linalool, which showed promise in reducing pain via the A2aR mechanism. Additionally, a clinical trial demonstrated that M1-repetitive transcranial magnetic stimulation (rTMS) reduced fibromyalgia pain for up to eight weeks, with functional improvements lasting up to 16 weeks.

SAP-001 Demonstrates “Best in Class” Data for Gout With Hyperuricemia Refractory to SOC XOI Therapy

SAP-001, a novel urate-lowering agent, demonstrated best-in-class efficacy in a Phase 2b trial, with a majority of patients achieving target serum uric acid levels by Month 3. The treatment showed potential for addressing hyperuricemia refractory to standard xanthine oxidase inhibitor (XOI) therapy.

Oxypurinol Formulation May Be Adapted for Gout Treatment

XORTX is advancing its oxypurinol-based formulation, XORLO, for the treatment of hyperuricemia in gout, with ongoing discussions with the FDA. The novel formulation aims to enhance safety and efficacy compared to existing xanthine oxidase inhibitors.

Patients With Tuberculosis at Increased Risk of Gout


A population-based study found that patients with a history of tuberculosis have a 42% increased risk of developing gout. The association may be linked to the metabolic effects of TB treatment, particularly medications that influence uric acid regulation.

New Pain Management Strategies for Fibromyalgia

Cannabis Sativa Terpenes Show Promise in Improving Post-Operative, Fibromyalgia Pain


Preclinical research suggests that specific Cannabis sativa terpenes, including geraniol and linalool, may alleviate fibromyalgia-related pain through A2a receptor modulation. These findings highlight the potential of terpene-based therapies as adjunctive pain management strategies.

TMS Reduces Pain, Yields Functional Improvements in Women With Fibromyalgia

A clinical study demonstrated that M1-repetitive transcranial magnetic stimulation (rTMS) significantly reduced fibromyalgia pain for up to eight weeks, with sustained functional improvements lasting 16 weeks. The findings support rTMS as a noninvasive neuromodulatory option for fibromyalgia management.

Deucravacitinib Improves PsA Symptoms and Quality of Life in POETYK PsA-2


The POETYK PsA-2 trial showed that deucravacitinib, a selective TYK2 inhibitor, led to significant symptom improvement and quality-of-life benefits in patients with active psoriatic arthritis. Efficacy was observed even in those with prior inadequate response to TNF inhibitors.

Ustekinumab, Other Biologics for PsA and PsO Have Similar Cardiovascular Safety


A comparative safety analysis found that ustekinumab, adalimumab, etanercept, and secukinumab exhibited similar cardiovascular risk profiles in patients with psoriatic arthritis and psoriasis. These findings provide reassurance regarding the long-term cardiovascular safety of biologic therapies in these populations.

March saw notable progress in rheumatology, with advancements in gout, psoriatic arthritis (PsA), and fibromyalgia. SAP-001 from Shanton Pharma showed promising results in a phase 2b trial for gout, while XORTX's oxypurinol-based XORLO is under FDA review. Tuberculosis was linked to a higher gout risk. In PsA, deucravacitinib improved symptoms and quality of life, and biologics showed comparable cardiovascular safety. Fibromyalgia research highlighted the potential of Cannabis sativa terpenes and M1-repetitive transcranial magnetic stimulation (rTMS) in pain management and functional improvement.

The rheumatology month in review emphasizes new research in gout, fibromyalgia, and psoriatic arthritis.

Rheumatology

Rheumatology condition center page is a comprehensive resource for clinical news and insights on rheumatologic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for arthritis, gout, nr-AxSpA, and more.

Gout

On the HCPLive gout page, resources on the topics of medical news and expert insight into gouty arthritis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on gout, and more.

Fibromyalgia

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

Psoriatic Arthritis

On the HCPLive psoriatic arthritis page, resources on the topics of medical news and expert insight into PsA can be found. Content includes articles, interviews, videos, podcasts, and breaking news on arthritis, and more.

Rheumatology Month in Review: March 2025

Lauren Blieden, MD, is a professor of ophthalmology at Baylor College of Medicine.

Long-Term Considerations in Angle Closure Glaucoma with Lauren Blieden, MD

 research evolves, long-term patient outcomes remain a key focus, particularly in angle closure cases. With critical gaps in long-term data, clinicians are refining management strategies while awaiting further research to guide best practices.

, Lauren Blieden, MD, a professor of ophthalmology at Baylor College of Medicine, highlighted critical updates in patient management, the role of patient education, and the importance of advocacy in ophthalmology. Blieden presented a talk entitled "Glaucoma/Narrow Angles” at the 

Texas Ophthalmological Association (TOA) Annual Meeting

Long-term follow-up data from the EAGLE trial remains a key area of interest in glaucoma research, particularly regarding the progression of angle closure as patients age. With nearly a decade since its publication, ophthalmologists are eager for updates to guide long-term management strategies. Blieden shared insights from her clinical experience, noting that while stable patients can often be monitored less frequently, uncertainties remain about disease progression in older age groups.

Blieden emphasized the importance of patient education, especially in diverse populations with a higher prevalence of angle closure. Early symptom recognition—such as sudden headaches or vision changes—can prevent delays in care. She also highlighted the need for patient awareness regarding medication-related risks and the importance of seeking specialized ophthalmic care rather than general emergency services in acute cases.

Blieden noted the Texas Ophthalmological Association (TOA), recently renamed the Texas Society of Eye Physicians and Surgeons, continues to serve as a vital platform for both clinical education and ophthalmic advocacy. Smaller meetings facilitate in-depth discussions on emerging research, case studies, and legislative issues, including scope-of-practice regulations and liability concerns.

Blieden LS. Glaucoma/Narrow Angles. Presented at Texas Ophthalmological Association (TOA) Annual Meeting. Houston, Texas. March 21-22, 2025

Videos

Blieden discusses long-term patient management in glaucoma, the importance of follow-up care, and the role of advocacy in ophthalmology.

Advancements in Narrow-Angle Glaucoma with Lauren Blieden, MD

Advancements in early detection and treatment for 

 are reshaping clinical approaches. In particular, breakthroughs in early lens extraction and automated imaging technologies are improving patient outcomes, with recent clinical trials offering new insights that challenge traditional approaches to risk and treatment.

, Lauren Blieden, MD, a professor of ophthalmology at Baylor College of Medicine, examined recent advancements in early detection, risk stratification, and treatment strategies of narrow-angle glaucoma. Blieden presented a talk entitled "Glaucoma/Narrow Angles” at the 

Blieden highlighted the growing evidence supporting early lens extraction as a potentially effective treatment for narrowing angles, noting that patients who underwent this procedure experienced fewer medications and interventions. Although diagnostic tools like gonioscopy remain in use, the expert emphasized the promising potential of automated anterior segment optical coherence tomography (OCT) imaging, which can detect narrow angles much earlier, offering a more reliable screening method.

She also discussed recent clinical trial findings, including the Zhongshan Angle-Closure Prevention (ZAP) trial and the EAGLE trial. The ZAP trial, which studied patients with occludable angles, showed surprisingly low rates of acute angle closure despite the high-risk perceptions of these patients. The trial extended its duration due to the low occurrence of events, suggesting that patients with occludable angles progress slowly and may not require immediate intervention. The EAGLE trial compared laser peripheral iridotomy and clear lens extraction for patients with narrow angles over 36 months, with a trend favoring lens extraction in not only reducing intraocular pressure (IOP) but also lowering the need for subsequent glaucoma surgeries.

Blieden emphasized that while the immediate risk of acute angle closure is lower than previously thought, prompt treatment is still important. Early lens extraction appears to be a promising option for these patients, with long-term benefits in IOP management and reduced need for additional glaucoma interventions. Blieden noted this evolving approach could how clinicians manage narrow-angle glaucoma, suggesting that early surgical intervention can prevent long-term complications.

Blieden describes recent advancements in the detection and treatment of narrow-angle glaucoma at TOA 2025.

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.

The March 2025 month in review spotlights a new episode of Crisis Point about CKD for National Kidney Month and renal FDA news.

Chronic Kidney Disease

Nephrology Month in Review: March 2025

Study draws correlative connection between semaglutide and nonarteritic anterior ischemic optic neuropathy, more data required to show causation.

Semaglutide May Increase Nonarteritic Anterior Ischemic Optic Neuropathy Risk

This March 2025 month in review covers key pulmonology updates, including new findings on pulmonary function tests and expert insights from the AAAAI/WAO Joint Congress.

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.

COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

Pulmonology Month in Review: March 2025

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 

These data highlight the susceptibility loci shared between HS and other inflammatory diseases among those with this condition.

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.

Plaque Psoriasis

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

Family History Plays Significant Role in Severity of Hidradenitis Suppurativa

Leandro Boer, MD, PhD, vice president of general medicines at Amgen

At ACC.25, Boer highlights treatment gaps in the US for lipid control in a high-risk ASCVD population.

Conference

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

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...

Atherosclerotic Cardiovascular Disease

Dyslipidemia

VESALIUS-REAL Reveals Lipid Control Gaps in US with Leandro Boer, MD, PhD

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.

HCPLive spoke with Levine about what is moving in the psychiatry pipeline and what is to come.

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Q1 and Q2 Psychiatry Updates, with Steve Levine, MD

Ahmad Masri, MD, MS, is the director of the Hypertrophic Cardiomyopathy Center at Oregon Health and Science University. 

Ahmad Masri, MD, MS, discusses how new options change the historic approach to the treatment of newly diagnosed ATTR-CM.  

Cardiomyopathy

Navigating Treatment in ATTR-CM's New Era, with Ahmad Masri, MD, MS

Study findings suggest COVID-19 is linked to a greater risk of long-term kidney dysfunction and new-onset advanced CKD than influenza.

COVID-19 Infection Increases Risk of Advanced CKD, Long-Term Renal Dysfunction

Daniel P. Judge, MD, is the Edwin W. and Teresa H. Rogers Endowed Chair for Cardiovascular Research at the Medical University of South Carolina.

Daniel Judge, MD, discusses data from a prespecified analysis of ATTRibute-CM examining the effects of acoramidis with and without concomitant tafamidis use.

Acoramidis, ATTR-CM, & Tafamidis: ATTRibute-CM Insights, with Daniel Judge, MD

Research presents a correlation between the index and age-related macular degeneration and suggests a causal relationship.

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.

Latest News

Atrasentan (Vanrafia) Receives Accelerated Approval in IgA Nephropathy

Opthea Announces Termination of ShORe and COAST Trials of Sozinibercept

Rheumatology Month in Review: March 2025

Long-Term Considerations in Angle Closure Glaucoma with Lauren Blieden, MD

Advancements in Narrow-Angle Glaucoma with Lauren Blieden, MD