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Connor Iapoce is an associate editor for 

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

Eyenovia has announced an update on the phase 4 study of tropicamide and phenylephrine hydrochloride ophthalmic spray (Mydcombi) 1%/2.5% for 

Announced on April 25, 2024, the phase 4 study was designed to characterize the efficacy and duration of effect of the lowest deliverable dose for pupil dilation (8 µL per eye). Notable highlights from the findings showed approximately two-thirds of patients could achieve clinically relevant pupil dilation at 30 minutes post-dose.

“The results of this study highlight the favorable efficacy and tolerability of Mydcombi dispensed through the Optejet®. Notably, dilation was already dissipating by 3.5 hours post-instillation, which is similar to published studies of dilating eye drops followed by the use of a mydriasis reversal agent,” Michael Rowe, chief executive officer of Eyenovia, said in a statement.

Mydcombi was approved by the US Food and Drug Administration (FDA) in May 2023, representing the first approved fixed-dose combination of tropicamide and phenylephrine for inducing mydriasis for diagnostic procedures and short-term pupil dilation.

 Its approval also marked the first product approved by any regulatory authority to use the company’s proprietary Optejet® device.

Previously, in October 2021, the company received a Complete Response Letter (CRL) from the FDA to their New Drug Application (NDA) for Mydcombi, requesting additional device testing related to the Optejet® dispenser.

 The resubmitted NDA for MydCombi was accepted by the FDA in December 2022 and was supported by the completed phase 3 MIST-1 and MIST-2 clinical trials.

For this phase 4 study, 29 individuals were treated with a half-dose of Mydcombi State University of New York School of Optometry and evaluated at the end of 2023. Results showed pupil dilation was achieved in 67% of patients at 30 minutes post-dose.

By the 60-minute mark, investigators found the percentage of pupil dilation increased to 86%. Most patients returned to a pupil size of <5mm between 3.5- and 6 hours post-instillation, with 93% meeting that point at the 6-hour mark. Safety data indicated the administration of a lower 8 µL volume was well-tolerated and minimal adverse events were reported.

Current mydriatic eye drops utilized in eye examinations are limited by several factors, including the potential for cross-contamination, difficulty instilling in those with limited mobility, and often, tolerability and safety issues.

 At higher levels, phenylephrine has been found to cause serious systemic cardiovascular side effects in older individuals, particularly those with high blood pressure.

The full data set highlighting the favorable efficacy and tolerability of Mydcombi is expected to be presented at an upcoming medical meeting this year, according to Eyenovia.

“These results suggest that for patients in which the lowest deliverable dose of tropicamide and phenylephrine may be desired, the precision and flexibility of the Optejet technology may be an option for eye care professionals and their patients,” Rowe added.

Eyenovia provides clinical and scientific update on FDA-approved products MydcombiTM and Clobetasol Propionate Ophthalmic Suspension. Eyenovia Inc. April 25, 2024. Accessed April 25, 2024. https://ir.eyenovia.com/news-releases/news-release-details/eyenovia-provides-clinical-and-scientific-update-fda-approved.

Iapoce C. FDA approves fixed-dose ophthalmic spray for Mydriasis. HCP Live. May 8, 2023. Accessed April 25, 2024. https://www.hcplive.com/view/fda-approves-fixed-dose-ophthalmic-spray-mydriasis.

K Lodhi SA, Ramsali MV, Kulkarni DK, Surender P, Murty S. Safety of tropicamide and phenylephrine in pupillary mydriasis for cataract surgery. Saudi J Ophthalmol. 2022;35(2):108-111. Published 2022 Feb 18. doi:10.4103/1319-4534.337859

Articles

Eyenovia assessed the duration of effect of the lowest deliverable dose of tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5% in a phase 4 study.

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Mydcombi Effective, Tolerable at Lowest Deliverable Dose for Mydriasis

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 

Topline data from the LEVEL UP trial indicate upadacitinib (Rinvoq) outperformed dupilumab (Dupixent) for the treatment of atopic dermatitis, according to an announcement from AbbVie. 

Announced on April 25, 2024, data from the phase 3b/4 trial, which included patients aged ≥12 years with moderate-to-severe 

 and either an inadequate response to or inability to use other therapies, suggest a greater proportion of patients achieved relief and resolution of symptoms with upadacitinib than with dupilumab.

“Too many patients are still not achieving optimal disease control in atopic dermatitis despite taking steps to manage their condition," Jonathan Silverberg, MD, PhD, MPH, director of clinical research and professor of dermatology at the George Washington University School of Medicine and Health Sciences, said in a statement. "Results from the LEVEL UP study highlight how treatment options such as upadacitinib can achieve high treatment goals in atopic dermatitis with combined measures of EASI 90 and NRS 0/1, not just itch resolution or just skin clearance."

Since receiving their initial approvals from the US Food and Drug Administration in 2017 and 2019, respectively, dupilumab and upadacitinib have become staples in the treatment algorithms for patients with a multitude of dermatologic conditions. The LEVEL UP trial was launched in 2022 to provide clinicians with greater insight into the comparative effects of these agents.

The study included design a screening period, an initial 16-week treatment period, and a subsequent 16-week period of treatment with adjustments which were protocol-defined. The study’s primary endpoint had been both a 90% or more Eczema Area and Severity Index score reduction (EASI 90) and a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at the 16-week mark.

Upadacitinib treatment during the trial was begun at 15 mg once per day and later the dosing was escalated to 30 mg per day based upon adult and adolescent patient responses. Dupilumab was started at a dosing regimen of 600 mg, followed by 300 mg over the course of every other week (Q2W) in subjects weighing ≥60 kg, and those weighing less were given a first dose of 400 mg, followed later by a 200 mg dose Q2W.

A substantially higher percentage of subjects in the study’s conclusion were shown to have achieved both of the endpoints (19.9% versus 8.9% for upadacitinib and dupilumab, respectively, 

< .0001). Among each secondary endpoint, the study’ investigators also found that upadacitinib had outperformed dupilumab.

Specifically, this had included a much higher proportion of upadacitinib-treated individuals with near complete skin clearance and little to no pruritus, with EASI 90 (40.8% versus 22.5%, 

 < .0001) and WP-NRS of 0/1 (30.2% versus 15.5%, 

The observed safety profile for upadacitinib in LEVEL UP was consistent with previous studies in AD. No new safety concerns emerged during the study. The most common adverse events reported were nasopharyngitis for both groups. Serious adverse events occurred at the same rate (0.9%) for both medications, with one serious infection in the dupilumab group and none in the upadacitinib group. No malignancies, major adverse cardiac events, venous thromboembolic events, or treatment-related deaths were reported in either group.

New Data Show RINVOQ® (upadacitinib) Demonstrated Superiority Versus DUPIXENT® (dupilumab) Across Primary and All Secondary Endpoints in an Open-Label Head-to-Head Atopic Dermatitis Study. AbbVie. April 25, 2024. https://news.abbvie.com/2024-04-25-New-Data-Show-RINVOQ-R-upadacitinib-Demonstrated-Superiority-Versus-DUPIXENT-R-dupilumab-Across-Primary-and-All-Secondary-Endpoints-in-an-Open-Label-Head-to-Head-Atopic-Dermatitis-Study. Date accessed: April 25, 2024.

New phase 3b/4 trial data compared both drugs efficacy and safety profiles for eczema patients, looking at adults and adolescents.

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Upadacitinib Superior in Efficacy to Dupilumab for Atopic Dermatitis in Head-to-Head Study

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.

Findings from a recent study are highlighting the safety and efficacy of tenofovir disoproxil fumarate for preventing mother-to-child transmission of 

 in female patients with a high viral load during the second or third trimester of pregnancy.

 also call attention to an increased risk of hepatitis flares during the postpartum period after nucleos(t)ide analog discontinuation, with 5 out of 7 participants experiencing a flare within 6 months of stopping tenofovir disoproxil fumarate.

According to the World Health Organization, an estimated 254 million people were living with chronic HBV infection in 2022. In highly endemic areas, it is most commonly spread from mother to child at birth, with infection in infancy and early childhood leading to chronic infection in about 95% of cases. Although transmission can be prevented with antiviral medication, the risk of postpartum hepatitis flares after treatment discontinuation may pose a health risk to infected mothers.

“In particular, in cases where nucleos(t)ide analog administration is discontinued after delivery, hepatitis flares due to termination of HBV suppression are an important concern,” Hayato Kawamura, of the department of gastroenterology and metabolism at Nagoya City University Graduate School of Medical Sciences in Japan, and colleagues wrote.

 “However, the association between antiviral therapy and hepatitis flares in women after the discontinuation of nucleos(t)ide analog for mother-to-child transmission prevention has not been elucidated.”

To examine the efficacy of nucleos(t)ide analog administration for the prevention of mother-to-child transmission of HBV and evaluate the risk of postpartum hepatitis flares after nucleos(t)ide analog discontinuation, investigators recruited pregnant women with HBV DNA ≥5.3 log IU/mL between September 2014 and March 2022 who received 300 mg tenofovir disoproxil fumarate orally once a day at approximately 28 weeks of gestation and discontinued treatment at 4–10 weeks after delivery. In total, investigators assessed the virological and biochemical parameters in 9 mothers after discontinuation, defining a hepatitis flare as an alanine transaminase (ALT) level ≥60 U/L.

HBeAg was positive in 8 cases with high levels of HBV DNA (7.7 to >8.2 log IU/mL), and negative in 1 case with 6.5logIU/mL of HBV DNA. The median time of tenofovir disoproxil fumarate initiation was 28 (interquartile range [IQR], 28–32) weeks of gestation. Tenofovir disoproxil fumarate was discontinued at 4 weeks postpartum in 6 cases, 5 weeks postpartum in 2 cases, and 10 weeks postpartum in 1 case.

Investigators noted a pair of cases were lost to follow-up after tenofovir disoproxil fumarate discontinuation. Of the remaining 7 patients, 5 experienced hepatitis flares within 6 months of tenofovir disoproxil fumarate discontinuation at a median of 11 (IQR, 9-17) weeks postpartum. Among these cases, the median peak ALT level was 165 (IQR, 108-262) U/L. In 3 of the 5 cases with hepatitis flares after treatment discontinuation, nucleos(t)ide analog was reintroduced.

Of note, none of the infants developed any congenital anomaly or acquired HBV infection during infancy. Accordingly, investigators suggested nucleos(t)ide analog administration appeared to be effective against mother-to-child transmission of HBV in pregnant women with high HBV DNA levels. However, they were also careful to outline potential limitations to these findings, including the limited number of cases included in the study and the fact that all included patients were treated with tenofovir disoproxil fumarate.

Nonetheless, they concluded that “the use of nucleos(t)ide analog in HBV-infected mothers with a high viral load during the second or third trimester of pregnancy was highly safe and effective against mother-to-child transmission. However, hepatitis flares were observed frequently in the postpartum period after nucleos(t)ide analog discontinuation.”

Kawamura H, Matsuura K, Ito K, et al. Efficacy of antiviral therapy for the prevention of mother-to-child transmission of hepatitis B virus and the risk of postpartum hepatitis flare after discontinuation of antiviral therapy. 

World Health Organization. Hepatitis B. Newsroom. April 9, 2024. Accessed April 24, 2024. 

https://www.who.int/news-room/fact-sheets/detail/hepatitis-b

Tenofovir disoproxil fumarate was safe and effective for preventing mother-to-child transmission of HBV, but discontinuation was linked to postpartum hepatitis flares. 

Hepatology

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

Postpartum Hepatitis Flare Risk Increases After Discontinuation of Antiviral Therapy

Patrick Campbell is the managing editor of HCPLive. Formerly the editorial lead of Endocrinology Network, Practical Cardiology, and Rheumatology Network, Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. He now helps to lead coverage in each of these respective areas for HCPLive. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA, and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

Anjali Dixit, MD, MPH
Credit: Stanford Medicine

A new study is adding to the discussions around whether or not patients with 

 should discontinue use of GLP-1 receptor agonists before surgery.

Results of the study, which were published less than a year after the American Society of Anesthesiologists (ASA) recommended preoperative withholding of GLP-1 receptor agonists, fly in the face of recommendations and indicate there was no increased risk of postoperative respiratory complications associated with use prior to surgery.

“Given increasing use of GLP-1 RAs, larger-scale evaluations of their perioperative risks are needed; however, a randomized trial of preoperative GLP-1 RA withholding may not be feasible,” wrote investigators.

 “Therefore, we used a claims database to evaluate the risk of postoperative respiratory complications among patients with diabetes and a prescription fill for GLP-1 RAs who underwent emergency surgery because these patients would be unlikely to withhold their medication in accordance with guidelines.”

On June 29, 2023, the ASA released guidance calling for patients to consider holding GLP-1 receptor agonists on the day of the procedure/surgery and for patients on weekly dosing to consider holding GLP-1 receptor agonists for a week prior. In a statement from the ASA announcing the publication of new guidance, the organization noted the recommendations came as the result of anecdotal reports purporting an association of delayed gastric emptying with use of GLP-1 receptor agonists and increased risk of regurgitation and pulmonary aspiration during general anesthesia and deep sedation.

With no end in sight for the growing demand of GLP-1 receptor agonist therapies, a team of 5 led by Anjali Dixit, MD, MPH, a pediatric anesthesiologist at Stanford Medicine, launched the current study to explore associations between postoperative respiratory complication Among patients with diabetes and a prescription fill for GLP-1 receptor agonist who underwent emergency surgery. Investigators pointed out their study was designed as an analysis of a claims database as a randomized trial may not be feasible. Investigators also pointed out patients undergoing emergency surgery were identified as the subjects of interest as these patients would be unlikely to withhold medication in accordance with the ASA guidelines.

Laparoscopic appendectomy
Laparoscopic cholecystectomy
Operative management of traumatic hip fracture
Colectomy for diverticulitis
Operative management of adhesive small bowel obstruction
Operative management of ovarian torsion
Operative management of testicular torsion
Operative management of ectopic pregnancy
Operative management of incarcerated or strangulated hernia
Laparoscopic or open repair of perforated peptic or duodenal ulcer
Transurethral intervention for nephrolithiasis
Upper endoscopy for foreign body removal
Upper endoscopy for management of bleeding peptic or duodenal ulcer

The Merative MarketScan Commercial Database was chosen as the data source for the analysis. Investigators performed a search of patients with type 2 diabetes and a GLP-1 RA prescription fill who had undergone any of 13 emergency surgeries between January 1, 2015, and December 31, 2021. For the purpose of analysis, the comparator group was composed of patients with diabetes and at least 1 fill for a non-GLP-1 receptor agonist antidiabetic agent.

The investigators' final sample included 23,679 patients. Among these, 14.8% (n=3502) had a GLP-1 receptor agonist fill. Compared to those without a GLP-1 receptor agonist fill, those with a fill were more likely to be male, use more antidiabetic agents, and have concomitant obesity. The most common type of surgery indicated, for both groups, was transurethral intervention.

The primary outcome of interest for the study was a composite of aspiration pneumonitis, postoperative respiratory failure, and/or admission to the intensive care unit through 7 postoperative days. Investigators noted multivariable logistic regression was used to estimate associations, with the fully adjusted model adjusted for demographic characteristics, indicators of diabetic severity including the Diabetes Complications Severity Index, Elixhauser comorbidities, and fixed effects for year and surgery type.

Upon analysis, results indicated the overall incidence of postoperative complications was 3.5% among those with a GLP-1 receptor agonist fill and 4.0% in the non-GLP-1 receptor agonist group (Odds Ratio [OR], 0.85; 95% Confidence Interval [CI], 0.70 to 1.04; P = .12). In adjusted analysis, results indicated there was no significant difference in the incidence of postoperative respiratory complications between these 2 groups (adjusted OR, 1.03; 95% CI, 0.82 to 1.29; P = .80). Investigators highlighted these findings were consistent with further adjustment in secondary analyses.

Investigators called attention to limitations within their study to consider when interpreting results. These limitations included being restricted to commercially insured patients, being unable to measure preoperative duration of GLP-1 receptor agonist use, lack of information on adherence, and not including GLP-1 receptor agonists fills for weight loss alone.

“Results of this study suggest that liberalizing the withholding guidelines for GLP-1 RAs preoperatively should be considered,” investigators concluded.

Dixit AA, Bateman BT, Hawn MT, Odden MC, Sun EC. Preoperative GLP-1 Receptor Agonist Use and Risk of Postoperative Respiratory Complications. 

 Published online April 22, 2024. doi:10.1001/jama.2024.5003

Campbell P. Asa urges withholding GLP-1 RA therapy prior to elective procedures. HCP Live. July 14, 2023. Accessed April 25, 2024. https://www.hcplive.com/view/asa-urges-withholding-glp-1-therapy-prior-to-elective-procedures.

A retrospective challenges preoperative withholding of GLP-1 RAs in diabetes patients undergoing surgery, citing no increased risk of postoperative respiratory complications.

Type 2 Diabetes

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GLP-1 Receptor Agonists Not Linked to Post-Op Respiratory Complications

Chun spoke on more recommendations for internal medicine physicians to give older adults related to aging, dementia, and statin use.

Audrey Chun, MD: Practical Recommendations to Give Older Patients for Exercise, Cognitive Health

American College of Physicians (ACP) Internal Medicine Meeting

 interview, Audrey Chun, MD, spoke with HCPLive on the major points discussed in her presentation ‘Multiple Small Feedings of the Mind: Addiction Medicine, Geriatrics, Endocrinology.’

Chun serves as both a professor and as vice chair of outpatient clinical services at the division of 

 and Palliative Medicine in the Icahn School of Medicine at Mount Sinai. After touching upon the topic of slowing patients’ aging through the use of exercise, Chun was asked about common questions asked of internists when discussing statin use for primary prevention in patients older than 80 years of age.

“I think especially as people get into their 80s and 90s, the question comes that ‘I've been on this medicine for 30 years but do I need it?’” Chun said. “We have some suggestions that if your life expectancy is limited, you're probably doing little harm in stopping the medication because you retain some of the benefits of the medicines for many years after stopping. But for others who may have many years ahead of them, for example if everyone in their family lives beyond 100 and they're 85 years old, they may be a person that you want to continue.”

Chun added that in a case such as this, a internal medicine physician might want to help such a patient prevent such issues as strokes or heart attacks.

“I think at one point, it was ‘everyone should be on it and be on it forever,’” she explained. “Now, we understand that there isn't necessarily a continued benefit.”

Chun also noted that there could be side effects that are really life-affecting such as muscle pain and weakness in older adults, perhaps making statins not worthwhile due to a lack of benefits counterbalancing the costs. Later, Chun touched on the topic of hearing loss and its surprising impacts on dementia.

“One of the things I think the internists may not be aware of is that when we look at the risk factors for developing dementia, about a third of them are potentially modifiable, meaning we could do something in our lifetime to lower our risk of developing dementia,” she said. “Some of them are pretty intuitive…About 9% of the modifiable risk related to dementia is actually related to hearing loss and that's something that people are not always aware of.”

To learn more about these subjects, view the full segment posted above. Check out more of 

The quotes used in this article were edited for the purposes of clarity. Chun has no relationships with entities whose primary business is selling, re-selling, producing, marketing, or distributing healthcare products used by or on patients.

Videos

Chun spoke in this interview segment about more recommendations for internal medicine physicians to give older adults related to aging, dementia, and statin use.

Internal Medicine

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Audrey Chun, MD: Recommendations on Statins, Connecting Dementia to Hearing Loss

The fracture risk is greater for nursing home residents with dementia, greater baseline blood pressure values, and no recent antihypertensive medication use, a new study found.

Antihypertensive Medication Linked to Fracture Risk Among Older Adults

Solomon discusses the health care system’s role in mitigating climate change and how health care professionals can help protect and inform their patients.

Caren Solomon, MD, MPH: How The Health Care System Can Combat Climate Change

Lana Pine is the editor of HCPLive Rheumatology. She is an experienced editor and technical writer with a demonstrated history of working in the banking and publishing industries. In her free time, she enjoys cooking, yoga, listening to podcasts, and drawing. She can be reached via email at LPine@mjhlifesciences.com.

Patients receiving abatacept experienced smaller increases in mean IMT, max IMT, and plaque score compared with the csDMARD cohorts. 

Rheumatoid Arthritis

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Abatacept Treatment May Slow Atherosclerosis Progression 

Article intelligence chatbots, including ChatGPT and Bard, varied in accuracy, comprehensiveness, and readability on glaucoma questions adapted from patient brochures. 

AI Chatbots Show Promise as Patient Information Source for Glaucoma

At the end of the trial, the study met its primary outcome, indicating therapeutic equivalence between the biosimilar (AVT05) and reference golimumab. 

Biosimilars

Proposed Golimumab Biosimilar AVT05 Meets Primary Endpoints in Moderate to Severe RA 

An observational study in the UK investigated the risk of adverse events related to colchicine prophylaxis after receiving allopurinol for gout.

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Patient Factors Predictive of Colchicine-Related Adverse Events in Gout

A new study found intensive topical therapy improves deep sleep and REM sleep for patients with psoriasis and atopic dermatitis after 2 weeks.

Plaque Psoriasis

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Sleep of Psoriasis Patients Improves with Intensive Topical Treatment

A recent meta-analysis of more than 60 studies suggests guselkumab and risankizumab had the longest drug survival of IL-17 and IL-23 inhibitors for psoriasis. 

Guselkumab, Risankizumab Boast Longest Drug Survival Among IL-17, IL-23 Inhibitors 

Positive topline results showed treatment response consistent with NefIgArd findings, regardless of whether participants had previously been treated with Nefecon or placebo.

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.

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.

Calliditas Announces Open Label Extension Results for Budesonide (Nefecon) in IgA Nephropathy

In this interview, Chun discussed recommendations for internal medicine physicians to give older adults for slowing aging as well as evidence for statins.

Latest News

Mydcombi Effective, Tolerable at Lowest Deliverable Dose for Mydriasis

Upadacitinib Superior in Efficacy to Dupilumab for Atopic Dermatitis in Head-to-Head Study

Postpartum Hepatitis Flare Risk Increases After Discontinuation of Antiviral Therapy

GLP-1 Receptor Agonists Not Linked to Post-Op Respiratory Complications

Audrey Chun, MD: Recommendations on Statins, Connecting Dementia to Hearing Loss