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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.

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 

 Assistant professor of dermatology at Vanderbilt Health

 Psychiatric certified physician associate from Alpha Psychiatric Services

Pediatric Dermatologist at Children’s Hospital Colorado

Brian Lehrschall is a government affairs specialist at the American Red Cross North Carolina. He is a patient with psoriasis: https://www.theeducatedpatient.com/view/how-glp-1-therapy-helped-brian-manage-psoriasis-and-diabetes 

Founder of The PsoriaSis Collective, an organization to provide resources & support for women of color living with psoriatic disease. She is also a patient with psoriasis, featured on The Educated Patient: https://www.theeducatedpatient.com/view/how-a-personal-struggle-sparked-a-movement-for-psoriasis-awareness

Silent Weight of Psoriasis: Addressing Depression, Anxiety, Stigma in Care

In recognition of Psoriasis Awareness Month this August, 

 spoke with assistant professor of dermatology Eva Parker, MD, of Vanderbilt Health, pediatric dermatologist Carla Torres-Zegarra, MD, of Children’s Hospital Colorado, psychiatry-certified physician associate Tess Quesenberry, PA-C, CAQ-Psy, from Alpha Psychiatric Services, and several patients with 

Dermatologists often recognize psoriasis as merely a skin condition, marked by redness, scaling, and flare-ups. However, for the 8 million Americans living with it, the challenges stretch far beyond redness, scaling, and flare-ups.¹ What’s less visible—and often more difficult—is the emotional toll.

“The plaques of psoriasis are often in visible locations, knees, elbows. It can affect the hands. It can affect the face, the ears, the scalp, and extend onto the neck. And so, it can be hard for individuals with psoriasis, who have poorly controlled disease, to hide their skin lesions, and in public, that can be embarrassing. People stare,” Parker told 

. “There's often an assumption that if you have something on your skin, it's contagious. All of this can contribute to low self-esteem in our psoriasis patients, and that in turn, contributes to things like depression and anxiety.”

Patients with psoriasis are 1.5 times more likely to develop depression than the general population, and anxiety symptoms affect up to half of those diagnosed.² Research suggests that the inflammation in psoriasis, involving TH17 cells in the brain, may contribute to depressive symptoms.³

Feelings of self-consciousness and fear of stigma can leave patients isolated, self-conscious, or misunderstood. These psychosocial challenges ripple outward, affecting relationships, work, and quality of life.

Routine dermatology visits are an opportunity to do more than check plaques—they’re a chance to ask about mood, stress, and coping. Even a quick, structured screening can uncover depression or anxiety that might otherwise go unnoticed, allowing clinicians to intervene earlier with appropriate support.

Studies have also shown that personality traits or psychiatric disorders can influence how patients perceive their skin disease. For instance, patients with OCD may be more prone to skin picking, and those with borderline personality disorder may be more prone to self-harming behaviors.³

Psoriasis begins on the skin, but its impact runs much deeper. By addressing both the visible and invisible aspects of the disease, clinicians can help patients move closer to true healing—inside and out.

“As dermatologists, we get desensitized to skin disease because we see skin disease all day, and it is something that we see widespread disease, we see severe presentation, so it may not impact us in the same way as it impacts patients,” Parker said. “It's easy to forget that the disease itself is very stigmatizing, and it can be very alienating for patients…the number one thing we can do in treating our patients with psoriasis is to see them, to ask how their disease impacts them as an individual, and to make every effort we can to help them navigate what resources are available, especially if there's concomitant mental health illness.”

Brief descriptions of the speakers featured in this project are provided below:

Featured: Ayesha Patrick (top left), Carla Torres-Zegarra, MD (top right), Tess Quesenberry, PA-C, CAQ-Psy (bottom left), Eva Parker, MD (bottom right)

 Pediatric Dermatologist at Children’s Hospital Colorado and Associate Professor of Dermatology at the University of Colorado School of Medicine. Host of Pediatrias en Línea, the first podcast for Spanish speaking providers produced by Children's Hospital Colorado.

Relevant disclosures include UCB, Inc for Parker and Otsuka America Pharmaceutical, ITI, Inc, ABBVIE, Neurocrine Biosciences, Alkermes, Takeda Pharmaceuticals, Almatica Pharma, and Teva Pharmaceuticals for Quesenberry. Torres-Zegarra has no relevant reported disclosures.

Hedemann TL, Liu X, Kang CN, Husain MI. Associations between psoriasis and mental illness: an update for clinicians. 

. 2022;75:30-37. doi:10.1016/j.genhosppsych.2022.01.006

National Psoriasis Foundation. Psoriasis Statistics. www.psoriasis.org. Published December 21, 2022. 

https://www.psoriasis.org/psoriasis-statistics/

Jafferany M. Special Report: Psychodermatology: Bridging Dermatology and Psychiatry. 

. 2025;60(3). doi:https://doi.org/10.1176/appi.pn.2025.03.3.2

Videos

Up to half of psoriasis patients report significant psychiatric symptoms, highlighting the importance of routine screening in practice.

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Dermatology

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Plaque Psoriasis

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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.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

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.

New research is shedding light on the benefits of adhering to a healthy diet and being physically active in the context of 

alcohol-attributable liver-related mortality risk

, highlighting notable attenuations in this risk across all drinking patterns, including heavy and 

In the study, National Health and Nutrition Examination Survey (NHANES) data were analyzed and linked to the National Death Index. Findings showed daily alcohol intake and binge drinking are independently associated with greater risks of liver-related mortality, but that this risk can be reduced with healthy dietary patterns and increased physical activity. Of note, women were found to achieve greater liver survival benefits than men.

“A significant knowledge gap exists regarding the interplay of dietary patterns and physical activity with alcohol-attributable liver-specific mortality. It is not well understood whether healthy diets or increased physical activity levels explain differences in liver-specific mortality risks between lifetime abstainers and light-to-moderate alcohol consumers,” lead investigator Naga Chalasani, MD, of the division of gastroenterology and hepatology at Indiana University School of Medicine, explained in a statement.

 “More importantly, it remains unclear whether a healthy diet and physical activity can lower liver-specific mortality in individuals engaging in high-risk alcohol consumption, such as heavy or binge drinking.”

To address this gap in research, he and colleagues assessed data from NHANES for the 1984-2018 cycles for 60,334 participants representing 151,920,199 persons of the US population.

Investigators gathered mortality follow-up information for participants from the date of the interview through December 31, 2019. Their death status was determined by linking survey data with death certificate records from the National Death Index. Liver-specific mortality was the primary outcome of interest and was ascertained using ICD-10 codes.

Self-reported alcohol use, diet quality based on the healthy eating index (HEI), and physical activity levels were obtained. Participants were categorized into 3 groups based on self-reported alcohol consumption:

Never drinkers, defined as individuals who answered "no" to ever having consumed at least one alcoholic drink in their lifetime

Former drinkers, defined as individuals who reported having consumed alcohol at some point in their lifetime but had not consumed any in the past 12 months

Current drinkers, defined as those who had consumed alcohol in the past 12 months.

Former and never drinkers were combined into a single group and considered as non-drinkers for the primary analysis. Physically active participants reported ≥ 150 min of moderate-intensity physical activity, 75 min of vigorous-intensity physical activity, or a combination per week.

During a mean follow-up period of 12.2 years (11.8 years for men and 12.6 years for women), 12,881 (21.3%) deaths were observed, including 252 (0.4%) due to liver disease. Increased risk of liver-related death was associated with older age (adjusted SHR [aSHR], 1.05), current smoking (aSHR, 1.66), diabetes (aSHR, 1.62), higher BMI (aSHR, 1.04), waist circumference (aSHR, 1.02), FIB-4 >3.25 (aSHR, 34.9), average daily alcohol intake (aSHR, 1.04), and binge drinking (aSHR, 2.06). Conversely, economically advantaged participants (aSHR, 0.42) and those who reported being physically active (aSHR, 0.65) or adhering to healthier diet quality (aSHR, 0.35) were linked to lower risk of liver-related death.

In both sexes and compared to abstainers, a non-linear, dose-dependent association was observed between average alcohol intake per day and liver-related death. Average alcohol drinks/day remained independently linked to liver-related death in men (aSHR, 1.04; 95% CI, 1.01-1.06) and women (aSHR, 1.08; 95% CI, 1.04-1.12). Similarly, binge drinking was associated with a greater risk of liver mortality among women (aSHR, 2.52; 95% CI, 1.44-4.41; PAF, 35%) than men (aSHR, 1.52; 95% CI, 1.04-2.29; PAF, 21%). Compared with no consumption, even light intake (aSHR, 1.08; 95% CI, 1.01-1.28; PAF, 2%) was associated with an increased risk.

Investigators noted adopting a healthier eating pattern (aSHR for top quartile HEI, 0.43; 95% CI, 0.18-0.97 in men and aSHR, 0.19; 95% CI, 0.08-0.47 in women) and being physically active (aSHR, 0.72; 95% CI, 0.37-0.95 in men and aSHR, 0.38; 95% CI, 0.18-0.76 in women) were independently associated with a lower liver-related death risk. Of note, women showed greater liver-specific survival benefits from diet quality and physical activity than men.

Further analysis revealed healthier dietary intake reduced liver mortality risk among non-heavy (aSHR, 0.35; 95% CI, 0.13-0.90), heavy (aSHR, 0.14; 95% CI, 0.04-0.82), and binge (aSHR, 0.16; 95% CI, 0.06-0.46) drinkers compared to unhealthier diets. Similarly, physically active participants had lower liver mortality risk among non-heavy (aSHR, 0.52; 95% CI, 0.28-0.94), heavy (aSHR, 0.64; 95% CI, 0.35-0.99), and binge (aSHR, 0.31; 95% CI, 0.10-0.88) drinkers.

“We found that adherence to high levels of physical activity and/or diet quality was associated with a lower risk of liver-related death across all drinking patterns, including 36% and 69% liver mortality risk reduction from physical activity and 86% and 84% liver mortality risk reduction from healthier eating among heavy and binge drinkers, respectively,” Chalasani said.

 “The uniqueness of our study lies in its ability to simultaneously assess the moderating effects of two important lifestyle behaviors on liver mortality risk across different levels and patterns of alcohol consumption in a representative US population, offering a more nuanced and complete view of the risks of drinking.”

Vilar-Gomez E, Nephew L, Gawrieh S, et al. Healthy eating and physical activity significantly lower sex-specific alcohol-attributable liver mortality in the United States. 

Elsevier. Study reveals beneficial effects of diet and exercise on alcohol-related adverse liver health. EurekAlert! August 27, 2025. Accessed August 28, 2025. 

https://www.eurekalert.org/news-releases/1095378

Articles

New research highlights the impact of healthy diet and physical activity on reducing alcohol-attributable liver-related mortality risk, even among heavy and binge drinkers. Analyzing NHANES data linked to the National Death Index, the study found that daily alcohol intake and binge drinking increase liver-related mortality risk, but this risk is mitigated by healthy lifestyle choices. Women benefit more than men from these interventions. The study underscores the importance of diet and exercise in lowering liver mortality risk across various drinking patterns, providing a comprehensive view of alcohol consumption risks.

Any alcohol intake was linked to a greater risk of liver mortality, but healthy diet and physical activity lowered this risk across all drinking patterns.

Hepatology

Addiction

Addiction medicine condition center page, resources on the topics of medical news and expert insight into clinical addiction can be found. Content includes articles, interviews, videos, podcasts, and breaking news on addiction therapy research, treatment, and drug development.

Healthy Diet, Physical Activity Improve Alcohol-Related Liver Health

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.

Frank Hu, MD, PhD | Image Credit: Menus of Change

When combined with a Mediterranean diet, calorie reduction and moderate exercise may cause up to a 1/3 reduction in 

The Mediterranean diet has historically been connected to better health outcomes via improved insulin sensitivity and reduced inflammation. The diet primarily consists of a high intake of fruits, vegetables, whole grains, and healthy fats, with a moderate amount of dairy and lean proteins, and little to no red meats.

Previous research, such as a trial from the University of Granada in 2020, which examined over 100,000 individuals via a structured literature search, has linked the Mediterranean diet with T2D incidence specifically. These studies frequently connect adherence to the diet and significant decreases in T2D risk – the University of Granada study saw a reduction of roughly 20% among those with a high score on the Mediterranean Diet Adherence Questionnaire.

“We’re facing a global epidemic of diabetes,” co-author Frank Hu, MD, PhD, Frederick J. State Professor of Nutrition and Epidemiology and chair of the Department of Nutrition, said in a statement to 

. “With the highest-level evidence, our study shows that modest, sustained changes in diet and lifestyle could prevent millions of cases of this disease worldwide.”

Conducted by researchers from the Harvard TH Chan School of Public Health, this study examined 4746 PREDIMED-Plus participants. Investigators randomly assigned these participants in a 1:1 ratio to either an intervention or a control group and followed their health outcomes over 6 years. Ages ranged from 55 to 75 years, and patients were overweight or obese and had metabolic syndrome. However, all participants were free of T2D and cardiovascular disease at baseline.

The intervention group kept to a strictly Mediterranean diet, reduced their caloric intake by roughly 600 calories/day, engaged in moderate physical activity such as brisk walking and strength and balance exercises, and received professional support for weight loss control. The control group adhered to a Mediterranean diet without any caloric restrictions, exercise guidance, or professional support.

Investigators reported a 6-year risk of 12% (95% CI, 11.9% to 12.1%) in the control group (349 cases) and 9.5% (95% CI, 9.4% to 9.5%) in the intervention group (280 cases). During the 6-year follow-up, T2D incidence was 31% (95% CI, 18% to 41%) lower in the intervention group compared to control, with an average risk reduction of -2.6 cases (95% CI, -2.7 to -2.4) per 1000 person-years.

Additionally, participants in the intervention group lost an average of 3.3 kilograms and reduced waist circumference by an average of 3.6 centimeters, compared to 0.6 kilograms and 0.3 centimeters in the control group.

“In practical terms, adding calorie control and physical activity to the Mediterranean diet prevented around 3 out of every 100 people from developing diabetes—a clear, measurable benefit for public health,” said co-author Miguel Martinez-Gonzalez, PharmD, PhD, professor at the University of Navarra and adjunct professor of nutrition at Harvard Chan School.

Harvard TH Chan School of Public Health. Mediterranean diet combined with calorie reduction and exercise may reduce risk of type 2 diabetes by nearly one-third. 

 August 25, 2025. Accessed August 28, 2025. 

https://www.eurekalert.org/news-releases/1095532

Ruiz-Canela M, Corella D, Martínez-González MÁ, et al. Comparison of an Energy-Reduced Mediterranean Diet and Physical Activity Versus an Ad Libitum Mediterranean Diet in the Prevention of Type 2 Diabetes: A Secondary Analysis of a Randomized Controlled Trial. Ann Intern Med. Published online August 26, 2025. 

Martín-Peláez S, Fito M, Castaner O. Mediterranean Diet Effects on Type 2 Diabetes Prevention, Disease Progression, and Related Mechanisms. A Review. Nutrients. 2020;12(8):2236. Published 2020 Jul 27. 

Recent research indicates that combining a Mediterranean diet with calorie reduction and moderate exercise can significantly lower the risk of type 2 diabetes (T2D) by up to one-third. The Mediterranean diet, known for its health benefits, includes high consumption of fruits, vegetables, whole grains, and healthy fats. A study involving 4746 participants showed that those adhering to a calorie-reduced Mediterranean diet with exercise had a 31% lower T2D incidence over six years compared to a control group. Participants also experienced notable weight and waist circumference reductions.

Recent research has shown a reduction of nearly 1/3 in type 2 diabetes risk associated with adherence to a Mediterranean diet, calorie reduction, and moderate exercise.

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.

Type 2 Diabetes

Mediterranean Diet and Other Lifestyle Changes May Reduce Type 2 Diabetes Incidence

Brian Weeks, MD, is an ENT-Otolaryngologist is at Senta Clinic.

Real-world evidence shows that GLP-1 therapies impact far more than weight loss alone. For example, patients taking GLP-1s have experienced significant reductions in major adverse cardiovascular events along with improved metabolic outcomes.

While these medications can play a critical role in helping patients live healthier and happier lives, they should not be viewed as a standalone solution for 

The Hidden Risks of Undiagnosed & Untreated Sleep Apnea

I often remind my patients that snoring isn’t just a nuisance—it’s frequently a sign of OSA, which affects > 30 million Americans, though 80% remain undiagnosed. Many GLP-1 patients may still struggle with snoring, fatigue, and morning headaches caused by nighttime airway collapse once they’ve achieved their weight loss goals. Lingering OSA symptoms may also silently undermine the progress these patients have made when it comes to reducing other health concerns and risks.

Even in mild to moderate cases, if left untreated, OSA increases the risk of hypertension, cognitive decline, and type 2 diabetes. Because the condition stems from unique physiologic causes, it requires its own targeted treatment approach—one that addresses airway function directly.

Beyond CPAP: Introducing Neuromuscular Electrical Stimulation (NMES)

Traditional OSA treatments, such as CPAP and oral appliances, are often met with adherence challenges. On the other hand, daytime neuromuscular electrical stimulation (NMES) offers a physiologic solution with improved adherence.

By retraining the tongue and airway muscles to maintain tone during sleep, NMES reduces both snoring and apnea episodes. Outside of treating OSA, NMES has been particularly successful in treating swallowing, voice, and laryngeal disorders. Additionally, NMES has been successfully leveraged in orthopedic and neurologic rehabilitation, as well as pain management.

Unlike pharmacologic treatment or CPAP, neuromuscular stimulation addresses the underlying dysfunction of airway collapse, providing lasting improvements without masks or machines.

As a practicing physician, I always consider my patients’ lifestyles in any prescription and clinical recommendation. Historically, CPAP has been the go-to solution for more severe cases of sleep apnea, and there has been a severe unmet need when it comes to non-invasive sleep therapies for mild to moderate OSA. Various in-market solutions can offer patients clinically tested, FDA-cleared relief while offering convenience and ease of use.

Takeaways for Multispecialty Doctors in the Era of GLP-1s

OSA is a cross-specialty condition, demanding vigilance beyond the ENT office.

 Patients achieving significant weight loss on GLP-1s should be screened for residual snoring, fatigue, or poor sleep quality.

OSA is a contributor to hypertension, arrhythmia, heart-failure risk, as well as a driver of cognitive decline and dementia if left untreated.

CPAP adherence rates hover between 30-60%, especially among patients with milder symptoms, leaving millions without sustainable therapy. With physiologic therapies, physicians can expand their toolkit to improve treatment adherence and their patients’ quality of life.

GLP-1 therapies are transforming weight loss treatment and chronic disease management as we know it, but they cannot replace dedicated treatment for OSA. Snoring and sleep apnea deserve recognition as independent conditions with serious long-term consequences. For multispecialty clinicians, the takeaway is clear: weight loss and OSA therapy can be complementary but are not interchangeable. By screening, referring, and treating OSA directly, clinicians can help patients breathe, sleep, and live better.

Bonavitacola, J. GLP-1 Receptor Agonists Reduce Adverse Cardiovascular Outcomes, Improve Survival. AJMC. August 2, 2025. 

https://www.ajmc.com/view/glp-1-receptor-agonists-reduce-adverse-cardiovascular-outcomes-improve-survival?utm_

Snoring and apnea treatment you can live with — and sleep without. Spring Sleep. 

GLP-1 therapies offer significant benefits beyond weight loss, including reductions in major adverse cardiovascular events and improved metabolic outcomes. However, they should not be seen as a standalone solution for obstructive sleep apnea (OSA), which affects millions and often remains undiagnosed. Traditional OSA treatments like CPAP face adherence challenges, while neuromuscular electrical stimulation (NMES) offers a promising alternative by addressing airway dysfunction. Multispecialty clinicians should recognize OSA as a serious condition with long-term consequences, ensuring comprehensive screening and treatment to complement weight loss therapies.

GLP-1 therapies support weight loss, but OSA requires dedicated airway treatment options such as CPAP or neuromuscular stimulation.

Sleep

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Obstructive Sleep Apnea

Helping Patients Sleep Better: Why the Airway Deserves Its Own Treatment Plan

Image Credit: US Food and Drug Administration

 has issued a Complete Response Letter (CRL) to Outlook Therapeutics' Biologics License Application (BLA) for ONS-5010, in development for the treatment of wet 

Announced by Outlook Therapeutics on August 29, 2025, the CRL cited ONS-5010's failure to achieve the primary efficacy endpoint in the phase 3 NORSE EIGHT trial. This was described as a lack of substantial evidence of effectiveness. The FDA suggested that confirmatory evidence of efficacy be submitted to support the next application. The FDA did, however, reiterate the achievement of NORSE TWO's primary effectiveness endpoint.

"While we are very disappointed with this outcome, we intend to meet with the FDA to receive additional clarity on their requirements to potentially approve the first on-label bevacizumab product specifically formulated, manufactured, and packaged for intravitreal use in the United States," Bob Jahr, chief executive officer of Outlook Therapeutics, said in a press release.

ONS-5010 is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. Bevacizumab is a recombinant humanized monoclonal antibody which selectively binds to all isoforms of human vascular endothelial growth factor (VEGF) with high affinity, neutralizing VEGF’s biologic activity through a steric blocking of its binding to its receptors on endothelial cells. This reduces endothelial cell proliferation, vascular leakage, and new blood vessel formulation in the retina.

Notably, ONS-5010 received regulatory approval in the European Union and the United Kingdom in 2024 for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet AMD.

ONS-5010 has had a long regulatory road in the US, having received a CRL from the FDA in August of 2023 after their first BLA. At the time, despite the pivotal NORSE TWO trial achieving its safety and efficacy endpoints, the FDA concluded it was unable to approve the BLA on account of several Chemistry Manufacturing and Controls (CMC) issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.

On April 8, 2025, Outlook Therapeutics announced the FDA’s acceptance of a new BLA, which allows ONS-5010 – under the brand name LYTENAVA – 12 years of regulatory exclusivity after regulatory approval. This resubmission was based on the NORSE EIGHT trial results, as well as the additional CMC data requested by the FDA.

NORSE EIGHT was a randomized, controlled, parallel group, masked, non-inferiority study investigating the difference in best-corrected visual acuity (BCVA) and retinal thickness between ONS-5010 and ranibizumab. After analysis, investigators announced on January 16, 2025, that ONS-5010 demonstrated noninferiority to ranibizumab at week 12.

ONS-5010 did not, however, meet its primary efficacy endpoint by week 8, as suggested in the special protocol assessment with the FDA. Investigators did note the consistent BCVA improvement across all time points, the generally good tolerability, and the safety and efficacy results compared to NORSE ONE, NORSE TWO, and NORSE THREE.

Outlook Therapeutics has requested a meeting with the FDA to explore further pathways for potential US approval. Additionally, the company has expressed intentions to expand into additional European markets.

"We remain committed to providing patients with a safe and effective alternative to compound Avastin manufactured in the United States," Jahr said. "It is important to also note that the CRL identified no other outstanding deficiencies in our BLA."

Outlook Therapeutics. Outlook Therapeutics Provides Regulatory Update on U.S. Food and Drug Administration Review of ONS-5010/LYTENAVA (bevacizumab-vikg) for the Treatment of Wet AMD. August 28, 2025. Accessed August 29, 2025. 

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-provides-regulatory-update-us-food-and-drug

Outlook Therapeutics. Outlook Therapeutics Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD. April 8, 2025. Accessed August 25, 2025. 

https://ir.oncobiologics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-acceptance-biologics-license-0

Campbell P. FDA Issues CRL for Ophthalmic Bevacizumab in Wet AMD. 

. August 30, 2023. Accessed August 25, 2025. 

https://www.hcplive.com/view/fda-issues-crl-for-ophthalmic-bevacizumab-in-wet-amd

Harp M. Outlook Therapeutics completes analysis of 12-week safety and efficacy results of NORSE EIGHT. 

 January 16, 2025. Accessed August 25, 2025. 

https://www.ophthalmologytimes.com/view/outlook-therapeutics-completes-analysis-of-12-week-safety-and-efficacy-results-of-norse-eight

The FDA issued a Complete Response Letter to Outlook Therapeutics' BLA for ONS-5010, citing failure to meet the primary efficacy endpoint in the NORSE EIGHT trial. Despite achieving noninferiority to ranibizumab, the trial did not meet the primary endpoint by week 8. ONS-5010, an ophthalmic bevacizumab formulation, previously received EU and UK approval. Outlook Therapeutics plans to meet with the FDA for further guidance and aims to expand into additional European markets. The FDA identified no other deficiencies in the BLA, and the company remains committed to US approval.

Outlook Therapeutics has expressed plans to meet with the FDA to address regulatory issues, as well as expand into European markets.

FDA News

Ophthalmology

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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.

FDA Issues CRL to Outlook Therapeutics' ONS-5010 for the Treatment of Wet AMD

These findings on teledermatology highlight its effectiveness as a potential solution for disparities in dermatology care within rural communities.

Teledermatology Cost-Effective, Scalable as a Solution for Rural Dermatologic Care Disparities

Albert Rizzo, MD, is the chief medical officer of the American Lung Association.

This episode of Lungcast features a discussion on emerging treatment approaches for SCLC.

Pulmonology

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Strategic Alliance Partnership

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Lungcast

Join the American Lung Association and HCPLive every month as Dr. Al Rizzo interviews world-leading experts on the great challenges, accomplishments, and stories in respiratory medicine.

Lungcast: Current Perspectives on Treatment of Small Cell Lung Cancer with Jacob Sands, MD

Viet Le, DMSc, PA-C, is a preventive cardiology PA at Intermountain Health and the former president of the Academy of Physician Associates in Cardiology.

Le discusses the implications of these new guidelines and whether the US healthcare system can manage the increasing public burden of hypertension.

Cardiology

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Hypertension

The HCPLive hypertension page is a resource for medical news and expert insights on high blood pressure. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for hypertension, and more.

Breaking Down 2025 ACC/AHA Hypertension Guidelines, with Viet Le, PA-C, DMSc

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

Santerus AG is preparing to initiate clinical trials of its blood purification technology in a variety of indications.

Lupus

Rheumatology

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NucleoCapture Gets FDA Breakthrough Designation for Systemic Lupus Erythematosus

The REMS label update reduces the frequency of liver function monitoring and removes the embryo-fetal toxicity monitoring requirement.

Nephrology

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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.

FDA Approves REMS Label Update for Sparsentan (Filspari) in IgA Nephropathy

These data on roflumilast cream 0.3% highlight the medication’s efficacy and safety in pediatric patients aged 2 - 11 years.

Roflumilast Cream 0.3% Effective for Psoriasis in Children Aged 2 to 11 Years

WAO’s updated framework adds mixed N-ERD, mixed NECD, and extends the pediatric term NIUAA to adults.


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.

World Allergy Organization Updates Classification of NSAID Hypersensitivity Reactions

A trio of experts reflect on unmet needs in gastroparesis, from diagnosis to treatment, and discuss advances that could shape the future of care.

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.

Rethinking Gastroparesis: Controversies in Care and the Search for Better Answers

Penny Asbell, MD, MBA, is a clinical professor of ophthalmology at UTHSC and external professor of biomedical engineering at the University of Memphis.

Parent company Iolyx Therapeutics has announced plans to move into phase 3 trials of the investigative immunomodulator later in 2025.

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FDA Issues CRL to Outlook Therapeutics' ONS-5010 for the Treatment of Wet AMD