Budesonide Oral Suspension for EoE: Advantages and Clinical Efficacy

Budesonide oral suspension was developed to address the practical challenges of delivering topical steroids to the esophagus, particularly in pediatric patients who struggled with metered-dose inhalers. The innovative formulation combines aqueous budesonide with a vehicle agent (originally Splenda) that coats the esophageal surface like a therapeutic lotion, providing sustained anti-inflammatory contact across the entire esophageal expanse. Data from Scintigraphic imaging studies demonstrated that the aqueous form alone fails to adequately coat the esophagus, but the combination vehicle achieves effective coverage. This led to FDA approval of Jorveza (budesonide oral suspension), offering a palatable, portable treatment option that teenagers particularly prefer due to its discreteness and convenience compared with mixing powder packets.

The phase 3 clinical trial represented the largest EoE study conducted in the United States, enrolling patients with significant disease burden averaging 75 eosinophils per high-power field. The study population reflected real-world clinical complexity, with over 80% of participants concurrently using proton pump inhibitors, 18% taking inhaled or nasal corticosteroids, and 10% following dietary restrictions. More than 50% had previously tried other therapies, and approximately 40% had required esophageal dilation, indicating these were treatment-refractory patients rather than easily managed cases.

Clinical efficacy results demonstrated robust histological improvement, with 62.4% of patients achieving the primary end point of 15 or fewer eosinophils per high-power field compared with only 1% with placebo. More stringent responses showed 53.5% reaching 6 or fewer eosinophils and 32.4% achieving deep remission with 1 or fewer eosinophils. Symptom improvement occurred in 52.6% vs 39.1% with placebo, though the notable placebo response reflects the complexity of symptom assessment and potential psychological factors. Importantly, 30% achieved combined histological and symptomatic response compared with 0% with placebo, representing the clinically desired dual improvement in both inflammation and patient-reported outcomes.

Panelists discuss how budesonide oral suspension was developed as a palatable, easy-to-use topical steroid that coats the esophagus like a lotion and demonstrated strong clinical efficacy in the largest US eosinophilic esophagitis (EoE) trial, with 62% of patients achieving histological response and 53% achieving symptom improvement, including 30% achieving both outcomes compared with 0% with placebo.

 Bryan Sauer, MD, MSc 

Aguh is an associate professor of dermatology and the director of the Ethnic Skin Program at the Johns Hopkins School of Medicine.

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

Skin of Color Savvy: Diversity in Dermatology Within the Modern Landscape, with Crystal Aguh, MD, and John Harris, MD, PhD

, Crystal Aguh, MD, associate professor of dermatology and director of the Ethnic Skin Program at the Johns Hopkins School of Medicine, and John Harris, MD, the founding Director of the Vitiligo Clinic and Research Center, founding director of the Autoimmune Therapeutics Institute and professor and chair of the Department of Dermatology at UMass Chan Medical School in Worcester, together explored the importance of mentorship, visibility, and leadership among dermatologists and dermatology trainees of different backgrounds.

Hosted by Skin of Color Society (SOCS) leaders, this podcast episode continues to delve into the latest research, clinical insights, and culturally intelligent and responsive care practices in the field of dermatology. Together, Aguh and Harris spoke on a variety of subjects in this area.

Aguh and Harris discussed the importance of diversity in clinical trials and research, emphasizing the need for diverse principal investigators and teams. Harris highlighted his experiences moderating a panel on incorporating diversity into clinical research, noting the challenges and benefits. They discussed the impact of federal regulations on National Institutes of Health (NIH) grants and the necessity of addressing questions about the importance of diversity.

Harris pointed out the challenges of addressing conversations regarding diversity among clinicians and in clinical research within the present political climate, highlighting that some have questioned whether to bring up the conversation at all. Both expressed optimism about the growth and impact of SOCS in advancing research and treatment for patients of color.

As the episode closed, the conversation reinforced the power of mentorship, the importance of role models, and the responsibility of current leaders to cultivate a more equitable future in dermatology. For both those in medical school and those who are current health care providers, the episode offers a compelling look at how connection, advocacy, and shared purpose can drive lasting change within the specialty.

To learn more about SOCS’s mentorship programs and initiatives, visit 

Editor's note: This interview was summarized with the aid of artificial intelligence.

This episode of the SOCS podcast features an in-depth discussion between Crystal Aguh, MD, and John Harris, MD, PhD.

Crystal Aguh, MD, FAAD

In this HCPLive Special Report, experts review ensifentrine's role as a novel maintenance therapy for COPD.

A Promising Pipeline for COPD

 Special Report – RX Reviews, Antonio Anzueto, MD, professor of medicine and section chief of pulmonary at South Texas Veterans Healthcare System, provides a review of the clinical trial data supporting ensifentrine (Ohtuvayre) as a maintenance treatment for patients with 

chronic obstructive pulmonary disease (COPD).

The US Food and Drug Administration (FDA) approved Verona Pharma’s application for ensifentrine on June 26—moments after the recording of this segment—on the basis of Anzueto and colleagues’ findings from the phase 3 ENHANCE trials.

 The indication made ensifentrine the first COPD therapy with a novel mechanism of action approved by the FDA in more than a decade.

Here, Anzueto provides a detailed breakdown of the supporting clinical trial data for ensifentrine, as well as a review of its unique clinical benefit as an inhaled, nonsteroidal, dual inhibitor of the dual inhibitor of the phosphodiesterase 3 and 4 (PDE3; PDE4) pathways. Additionally, he and panel moderator David M. Mannino, MD, chief medical officer of the COPD Foundation and professor at the University of Kentucky, discuss the current state drug development in COPD, and what impact the FDA approval of ensifentrine may have on clinicians and their patients.

Check out the entire 3-part Special Report series, ‘COPD: New Therapy Breakthroughs’:

Part 1: What the Ensifentrine FDA Approval Means for COPD

David M. Mannino, MD, Chief Medical Officer and Co-Founder of the COPD Foundation, and Professor of Internal Medicine, Pulmonary, Critical Care and Sleep Medicine at the University of Kentucky.

Antonio Anzueto, MD, Professor of Medicine and Section Chief of Pulmonary at South Texas Veterans Healthcare System.

Stephanie Christenson, MD, Associate Professor of Medicine, Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine at University of California, San Francisco.

Kunzmann K. FDA Approves Ensifentrine (Ohtuvayre) for COPD. 

. Published June 26, 2024. https://www.hcplive.com/view/fda-approves-ensifentrine-for-copd

Kunzmann K. Ensifentrine Significantly Improves COPD Lung Function, Exacerbations. 

. Published August 9, 2022. https://www.hcplive.com/view/ensifentrine-significantly-improves-copd-lung-function-exacerbations

What the Ensifentrine FDA Approval Means for COPD

David Mannino, MD

Dermatologists Drs Tina Bhutani and Scott Boswell and patient Kanya Oul share resources and tools available to cope with generalized pustular psoriasis (GPP).

Tips for Managing Generalized Pustular Psoriasis (GPP)

This is a video synopsis/summary of a panel discussion involving Tina Bhutani, MD; J. Scott Boswell, MD; and a patient.

In the concluding segment of the discussion, the patient emphasizes the importance of healthcare providers listening to their patients and believing their experiences. She credits her doctor with saving her life and underscores the significance of finding a reliable healthcare provider who understands the patient's condition. The patient encourages providers to educate themselves and be proactive in referring patients for appropriate care.

The speaker echoes the importance of education, stressing the need for healthcare professionals to stay updated on advancements in their field. He emphasizes the role of primary care physicians and emergency medicine practitioners in recognizing and treating severe skin conditions like generalized pustular psoriasis (GPP). The speaker shares his proactive approach to adopting new treatments for the benefit of his patients.

Overall, the discussion highlights the importance of patient-provider communication, education, and collaboration in effectively managing conditions like GPP. The participants express gratitude for the opportunity to share their insights, underscoring the value of such discussions in improving patient care.

Video synopsis is AI-generated and reviewed by HCPLive editorial staff.

Dermatologists Drs Tina Bhutani and Scott Boswell and a patient share resources and tools available to cope with generalized pustular psoriasis (GPP).

J. Scott Boswell, MD 

 I have 1 last question for all 3 of you. I’ll start with David. What advice do you have for ophthalmologists and other health care professionals taking care of our patients with geographic atrophy [GA] or the earlier stages of age-related macular degeneration?

 The take-home message is that the times are changing. It’s no longer the mantra of, “We can’t do anything for dry age-related macular degeneration. We can’t do anything for geographic atrophy. We play no role in altering the course of that disease.” Hopefully, it’s a new day and a new time for our patients and our communities, so don’t hesitate to send us any patient you suspect may have signs of [age-related] macular degeneration. We’re happy to evaluate them and determine whether they qualify for the therapy and follow up with you about what we found.

 We’re fortunate to be retina specialists. I love what we do—we all love what we do—and this is a very exciting time. We finally have treatment for something we never had treatment for, and breakthroughs like this shouldn’t be taken for granted in medicine. For our colleagues out there, it’s important for them to know that we have options and that there are things we can do. As Dave said, get these patients in to see us so we can start stratifying them, because it’s going to come in a rush. We’re going from no treatment at all to 1 option and then potentially another option. It’s a very exciting time, and it’s a privilege to be here.

 I don’t want our colleagues to be underwhelmed by the 20% slowing of the growth rate of GA lesions, give or take some percentage points. This is the first treatment that alters the course of this neurodegenerative disease. I hope everyone will look at the FDA label once we get an approval and have a discussion with patients. Try to avoid a paternalistic approach to patient care, where we don’t think they’ll benefit. It’s hard for us to quantify and understand the disease burden caused by GA. We can’t hang our hats on visual acuity, and we may not be good communicators with our patients. Patients will select themselves. I encourage my colleagues to have a discussion with every patient who meets the label so that they understand the value proposition and to see if they want to proceed with this course of treatment.

 Well said. Before we conclude, I’d like to get brief final thoughts from each of you. David?

 This has been an excellent discussion. I learned a lot. It’s been a pleasure to hear all your voices. I’ve learned a lot listening to you guys. Thank you for having me.

 I agree 100%. This is where the magic happens. I love these discussions. I always learn a lot. Hopefully the audience learned a lot. Thank you for having us, Nora.

 I learned that in my injection clinics I’m going to have to monitor patients for safety, so thank you for that pearl.

 I couldn’t agree more. I’d like to thank you all for the very rich and informative discussion. I’d like to thank the audience. If you enjoyed the content, please subscribe to our e-newsletters to receive upcoming 

 and other great content right in your in-box. Thank you.

Drs Eleonora M. Lad, David R. Lally, Jaynath R. Sridhar, and Nancy M. Holekamp share takeaways for health care professionals taking care of patients with geographic atrophy and earlier stages of age-related macular degeneration.

Advice to Physicians Treating Geographic Atrophy 

Jayanth Sridhar, MD

Jennifer Prevot, MD, is a pulmonary and critical care medicine fellow at Mount Sinai Hospital.

Using AI to Explore CPAP’s Impact on Abdominal Obesity in OSA, with Jennifer Prevot, MD

 remains a prevalent and serious disorder closely linked with 

, particularly abdominal adiposity. OSA is associated with an increased risk of 

, but the effectiveness of continuous positive airway pressure (CPAP) therapy, the standard treatment for OSA, in improving cardiovascular outcomes remains unclear.

the American Thoracic Society (ATS) International Conference 2025

 by Jennifer Prevot, MD, a pulmonary and critical care medicine fellow at Mount Sinai Hospital, addresses this gap in research by leveraging artificial intelligence to explore the relationship between OSA severity and abdominal obesity metrics, including visceral and subcutaneous adipose tissue (VAT and SAT) volumes and VAT metabolic activity, and to assess changes in these metrics following CPAP intervention using [18F]-Fluoro-2-deoxy-D-glucose (FDG) positron emission tomography (PET) combined with magnetic resonance imaging (MRI).

“There is a lot of interest in obesity and obstructive sleep apnea, and CPAP has been the standard treatment for a very long time,” Prevot explained to 

. “However, it's still questionable if it actually does anything in terms of cardiovascular risk factors. One thing that we know is that obesity kind of links everything, so I thought it would be interesting to look at abdominal obesity in particular and see the relationship it has with OSA and if CPAP therapy can modulate any risk factors.”

She and a group of investigators retrospectively analyzed PET/MRI scans from 115 adults with newly diagnosed OSA, both before and after 3 months of CPAP therapy. They determined OSA severity using portable sleep testing, defined by the respiratory disturbance index (pRDI). A deep learning model, using a transfer learning approach, segmented regions of interest (ROIs) within the subcutaneous and visceral adipose tissue compartments on MRI.

“Not only was the imaging technique that we used novel, because no one else has been using PET MRIs to look at visceral adipose tissue inflammation in the body, but we also established a relationship with our biomedical engineering department to automate the process in which we segment these compartments,” Prevot explained. “Not only do we have a novel imaging tool that we're using to look at metabolic activity of the abdominal tissue, but we are also applying a novel method to do this segmentation.”

Participants had an average age of 47.0 (standard deviation [SD], 11.97) years, were predominantly male (84.0%), and had an average BMI of 31.85 kg/m² (SD, 5.08). The mean pRDI was 32.53 events/hour (SD, 19.21).

Investigators noted OSA severity was not significantly associated with baseline VAT SUVmean (0.02%, confidence interval [CI], -0.21 to 0.25; 

= .87) and CPAP therapy did not significantly alter VAT SUVmean (-2.17%, CI, -5.02 to 0.77; 

= .15), VAT volume (-0.98%; CI, -2.41 to 0.47, 

= .19), or weight (0.30%; CI, -0.83 to 1.43; 

= .61). However, they called attention to a significant reduction in the VAT/SAT volume ratio (-1.70%; CI, -3.28 to 0.09; 

Looking ahead, Prevot emphasizes the potential of exploring these fat distribution metrics in the context of GLP-1 therapies, which are gaining attention for their metabolic benefits. She also highlights the possibility of evaluating changes in tongue fat, a known anatomical contributor to OSA, as an area for future investigation.

Editors’ note: Prevot has no relevant disclosures.

Prevot J, Patel H, Fauveau V, et al. Applying Artificial Intelligence to Measure Abdominal Adipose Metrics in Obstructive Sleep Apnea Before and After CPAP Therapy [abstract]. 

https://doi.org/10.1164/ajrccm.2025.211.Abstracts.A4759

Prevot describes her research exploring the relationship between OSA severity and abdominal obesity metrics as well as changes in both metrics following CPAP.

Jennifer Prevot, MD

Kent L. Reifschneider, MD

The panelists stress the significance of a comprehensive approach to patient care.

Cardiometabolic Medicine: Seeing the Patient as a Whole

The panelists stress the significance of a comprehensive approach to patient care, acknowledging the interconnected nature of cardiovascular, kidney, endocrine, and obesity-related benefits, and highlighting that addressing secondary diseases can minimize overall disease risk in patients.

Michael Koren, MD, FACC 

 Before we close, now that we have this exciting tool, what will each of you be doing in your own center for your patients and for your group to screen patients and get this tool on board, assuming it is paid for, which is a very big assumption, and assuming you’ll have the capability to have a 14-day infusion somewhere. Who will you be screening, and how will you spread the word among your colleagues within your own groups? Dr Goland, why don’t we start? We’ll go around, then you, Dr Simmons, and Dr Quattrin, so I can learn and steal the best-case scenario from each of you.

 I’m waiting for more information about the rollout. Patients and family members who specifically want the drug will do the antibody screening commercially. We are going to come up with our plan, which will involve some element of home care, I hope, because I think that would be the easiest for the patients. It’s difficult to get around in New York, but we’re working out the details.

 Dr Simmons, anything different that you’d be doing?

 As we’ve talked about, people with a family history are at highest risk. Those are the people who we definitely have always tried hard to get screened. The messaging now when you say the same thing is a lot more interesting with something being available. I’m hoping that the same messaging we’ve been giving about getting our relatives screened will result in more screening happening through TrialNet, for example. We also have the opportunity to do general population screening in Colorado. We’re working with a lot of pediatric education health networks through our system to get the word out to let people know they can be screened. The autoimmunity for children study can screen remotely now too, so we’re working with places that don’t have the opportunity to screen or even a great laboratory option for commercial antibodies, where we can help do screening remotely. I’m also helping to lead a project called Ask the Experts, where if somebody tests positive for antibodies in an area that’s more rural and doesn’t have support, we try to work with a local provider to train them on how to support that patient, and then in the meantime can provide remote care.

That is kind of a big picture of how we’re going to do screening. Hopefully, in lots of people and supporting lots of people. As far as administering teplizumab, there are many details to work out, but I have the privilege of being involved in starting an early type 1 diabetes clinic at our center. So we’re hoping to be able to administer the medication at our center once we work out all of the logistics.

 Dr Quattrin, anything different you’ll be doing?

 Informing all health care professionals that this is available is important, and making it easy for them to order these antibodies, telling them, this lab, this code, make it easy so they don’t have to spend a lot of time. In terms of a systemic and sustainable approach, there is a need for lobbying. In New York state, and Dr Goland knows, we screen for conditions that are far rarer than T1D [type 1 diabetes]. The difference and impact in addressing and preventing, or diagnosing early, may not be as relevant in terms of cost-benefit. I think we need to also lobby, and from my standpoint until I can do something like that, I’m going try to connect with Kimberly’s group and any other group to try to test as many people as possible.

As far as the practical implications, the pediatrician is the captain of the ship, so the family will talk with them. They always do when we’re proposing a trial, and we often talk with them ourselves. When you hear even the remote possibility of cytokine release syndrome, there is an uneasiness. It’s important that the data that are available regarding the timing of when these adverse effects occur, which is usually earlier, not only the incidence but the timing and the severity, is widely explained and available because it makes a difference when you might be able to do 3 injections at the site and the rest of the infusion possibly at home. I don’t know that right now my colleagues and I would feel comfortable with the treatment being done at home. There are tons of details to be worked out in terms of being able to administer the new medicine.

 What I plan on doing in my own site, I work with 15 adult endocrinologists. First, I have a call tomorrow with the chief of medicine to say, if there’s any interest, we could be an infusion site. I know we don’t know the logistics yet, will it be initiated in the office, as you said, and then the rest at home, or some kind of hybrid model of that? But to do a mass mailing like the way I would normally solicit patients for clinical trials, we could leverage our electronic records. I could identify everyone in the practice with type 1 diabetes and have an appropriately crafted letter talking about the antibodies. Of course, they’d have to check to see if the antibody levels are covered, and where they can get them free or for a reasonable price commercially available. But I wouldn’t send that letter until we have the tool to do something about it, not just to inform them about it. Either they’ll go to a pediatric endocrinologist if it’s positive for the rest of the work-up, to their adult endocrinologist, or a referral or something like that to do this bigger time, to be able to do that. It’s such an exciting tool for all of us, and you’ve all made me more enthusiastic for what’s on the horizon.

I’d like to thank all of you for this rich and informative discussion. Before we conclude, I’d like to get any final thoughts from each of you on what key message you would give to your colleagues. We’ll start with you, Dr Goland.

 This is a very exciting time for people with type 1 diabetes and their relatives. On the horizon are opportunities for delay and eventually prevention and cure of type 1 diabetes. Stay tuned.

 I would say the door has now opened, which is extremely exciting, and I look forward to seeing what comes through the door in the future. I think everyone should feel very excited and hopeful, and not overwhelmed, because it can be very overwhelming. There’s so much information. There are great resources out there to support anyone who is interested in screening, or potentially administering a medication, or interested in a clinical trial. The Juvenile Diabetes Research Foundation has a page on how to get screened. TrialNet, of course, has information on how to get screened. The Autoimmunity Screening for Kids program has information on screening. You have at least 3 great resources to reach out to, to get support.

 I echo what Drs Goland and Simmons said. It seems almost like a dream for those of us who have been involved in this field for such a long time. People with type 1 diabetes deserve this and they deserve more. There’s so much innovation that if we can delay the onset, they may be able to take advantage of those innovations and new therapies. It’s important that we are not in a silo as subspecialists, but rather we collaborate with all the health care professionals. As I mentioned, I know TrialNet can mail a kit, and there are other efforts that make things possible for families to look at this and look at the future as a brighter future.

 Well, thank you. I’ve learned a great deal from each of you. If our audience even learns a fraction of what I’ve learned, it’s very successful. Thanks for watching this 

on “The Future of Type 1 Diabetes Management.” If you enjoyed the content, please subscribe to the e-newsletters to receive upcoming peer exchanges and other great content in your inbox. The material contained in this document is the property of Intellisphere LLC and should be considered confidential for internal purposes. Thank you very much for joining us.

Drs Robert Busch, Robin S. Goland, Kimberly Simmons, and Teresa Quattrin discuss strategies to facilitate screening of type 1 diabetes and improve management of disease.

Strategies to Improve Screening and Diagnosis of T1D

Robin S. Goland, MD

Walt Whitley, OD, MBA | Image Credit: Virginia Eye Consultants

2025 American Optometric Association Conference

 in Minneapolis, MN, Walt Whitley, OD, MBA, optometrist at Virginia Eye Consultants, presented his lecture on the role biologic therapies play in 

Over the last two decades, a wide variety of biologic therapies have been investigated and approved for several different ocular diseases, including 

, scleritis, and orbital inflammation. Medications such as corticosteroids and cytokines have revolutionized the treatment landscape for these diseases, and further drugs in the pipeline currently promise even further advancement.

Whitley named what he believes are some of the most critical biologic treatments currently on the market, primarily for the neurotrophic keratitis.

“The most common thing that we’re going to see is neurotrophic keratitis, and there’s several different treatments that are available,” Whitley told 

 “We talked about both cryopreserved and dry amniotic membrane. We talked about topical biologic therapies such as cenegermine, which is 1 drop every 2 hours 6 times a day for 8 weeks, which shows the effect of rehabilitating those nerves, regenerating those corneal nerves to help that surface heal to improve our patients’ conditions.”

Whitley also spoke to the confusion and uncertainty inherent in such a wide range of possible treatments. Individual clinicians can often wind up overwhelmed by the sheer volume of choices, according to Whitley.

“The real-world barrier when it comes to incorporating biologics within eye care is often what is available, so there’s confusion because there’s so many different things that are out there,” Whitley said. “Every single time you turn on the TV, there’s a commercial about some type of biologic, so it can get confusing.”

Delving further into this, Whitley described the frustrations born of too many choices, chief among them the conflicting guidelines and regulations.

“The confusion is, where do I prescribe it? What are the steps? How are my patients going to get it? How long are they going to take the medication? So, it’s going to require education for us, the providers, but also for the patients themselves,” Whitley said.

Looking ahead, Whitley expressed interest in a slew of advancements on the horizon, highlighting everything from neuropathic corneal pain to ocular surface disease.

“I’m looking for things that are going to help our patients,” Whitley said. “In my cornea practice, we have many patients that are suffering from neuropathic corneal pain. We know that their corneal nerves are firing abnormally, and so in those cases these patients are in pain and they’re looking for some kind of treatment. If we can find a way to address this for our patients, it is only going to benefit them.”

Additionally, given the status of several biologics as frontline therapies for various ocular diseases, Whitley instead turned his attention to improving both testing and care for various diseases.

“I was part of a neurotrophic keratitis study group, and one of the callouts we had was anytime patients had ≥2 staining or higher, that’s where we needed to check for corneal sensitivity. Is it present? Is it reduced or is it absent? If it’s reduced or absent, then we need to do one of our therapies, whether it’s the membranes, the drops, et cetera, to help our patients.”

Whitley W. The Role of Biologics in Eye Care. Presented at the 2025 American Optometric Association Conference in Minneapolis, MN, June 25-28, 2025.

Lim L, Suhler EB, Smith JR. Biologic therapies for inflammatory eye disease. Clin Exp Ophthalmol. 2006;34(4):365-374. doi:10.1111/j.1442-9071.2006.01225.x

Whitley speaks to the plethora of available biologics, the choice paralysis that can accompany the wide range of options, and the future of the industry.

Authors