Anna Bruckner, MD, is a pediatric dermatologist, a professor of dermatology and pediatrics at the University of Colorado School of Medicine, and section head of pediatric dermatology and co-director of the Epidermolysis Bullosa Center of Excellence at Children’s Hospital Colorado.

Importance of Birch Triterpene Findings for Epidermolysis Bullosa, with Anna Bruckner, MD

Following the phase 3 EASE study assessing the long-term efficacy and safety profile of birch triterpenes (Filsuvez), also known as Oleogel-S10, for dystrophic EB (DEB) and junctional EB (JEB), the trial’s 24-month, open-label phase took place.

 interviewed EASE investigator Anna Bruckner, MD, a professor of dermatology and pediatric dermatologist at the University of Colorado, to highlight her team’s conclusions on birch triterpenes effectiveness as a treatment for EB. In this segment, Bruckner was asked about the significance of the findings for patients.

“I think it is important keep these findings in mind with the overall picture of what exactly patients with EB have have to go through,” Bruckner said. “This therapy is designed to help wounds close faster, but it does not necessarily guarantee that those wounds are going to be staying closed, because it's not replacing any affected abnormal proteins in EB.”

Nevertheless, Bruckner added that faster wound healing is, for many patients, still clinically meaningful and likely would result in less wound burden. She added that this could even result in a reduction in terms of cost among individuals with EB. Later, Bruckner was asked to comment on patients’ unmet needs.

“I think that in addition to this therapy, there's 1 other approved treatment for EB,” Bruckner said. “It is beneficial for patients to have faster wound healing. I think what patients would also like to see is more durability of wound healing, meaning that the wounds are not just healing faster but they are staying closed.”

Bruckner further noted that only a small number of wounds can be treated at an individual time, highlighting another unmet need among those with EB.

“So you know treatments that better address the totality [are needed], so that the wound burden of patients are [addressed],” Bruckner said. “Treatments that also address some of the mucosal manifestations, whether or not you know that's the eyes, the mouth, the esophagus, and especially for our patients with recessive dystrophic EB, would also, I think, be really important. We also need better treatments for symptoms.”

Bruckner was then asked about the treatment pipeline for EB and what drugs may become available in the near future.

“I think what's exciting is that there are treatments being developed specifically for EB, and we also have the potential to use therapies that have been developed for other indications sort of in an off-label fashion, to treat some of the the symptoms that we're dealing with,” Bruckner said. “But in terms of what might be coming down the pipeline, a company called Abeona that is developing a therapy called pz-cel…looking at genetically corrected keratinocyte graphs for patients with recessive dystrophic EB. So I think that that's certainly very exciting. A similar approach, but using patients fibroblasts that have been genetically corrected, is also being investigated, and that could potentially be promising as well.”

To learn more, view the full interview segment posted above.

The quotes summarized in this article were edited for the purposes of clarity.

Bruckner noted the following disclosures for her interview: Amryt Pharma / Chiesi (contracted research, advisor/consultant, speaker); Castle Creek / Fibrocell (contracted research, advisor/consultant); Krystal Biotech (consultant); Phoenix Tissue Repair (contracted research); Phoenicis Therapeutics (formerly ProQR/Wings) (contracted research); RheaCell (contracted research); Twi Biotechnology (contracted research, consultant).

Murrell DF, Bodemer C, Bruckner AL, Cunningham T, Davis C, Fernández MF, Kiritsi D, Maher L, Sprecher E, Torres Pradilla M, Kern JS. Long-term safety and efficacy of Oleogel-S10 (birch bark extract) in epidermolysis bullosa: 24-month results from the Phase III EASE Study. Br J Dermatol. 2025 Jan 16:ljaf022. doi: 10.1093/bjd/ljaf022. Epub ahead of print. PMID: 39821055.

This interview highlights the significance of Bruckner’s recent phase 3 data on birch triterpenes as a potential treatment for dystrophic and junctional EB, as well as patients’ unmet needs.

Anna Bruckner, MD

Even gazing at his face on the computer screen, I could feel his concern. He was 21 years old and seeking a consult with a cardiologist. He was not worried about a problem he had at the moment, but his future. In this horrific time of the COVID virus, this young college student applying to medical school was aware of the much greater and longstanding pandemic—the heart attack.

His father, age 62, had already had 2 heart attacks (myocardial infarctions) and five “stents” placed inside of the arteries of his heart. The young man had seen doctors in the last few months about sinus problems, and on 3 occasions he was told that he had high blood pressure. His family doctor had ordered recent blood tests for him and told him that his cholesterol was “a little high.” He wanted to know if I could help him avoid the fate of his father as he got older. I was confident that I could.

In reality, his father was fortunate. He had suffered from heart attacks due to a buildup of cholesterol inside of his heart arteries but had survived. So far, he had avoided the final wrath of what cardiologists called “The Widowmaker.”

I first heard the term Widowmaker when I was a medical student, struggling to learn to deal with the loss of too many of the heart attack patients I was seeing in the hospital. Many of these unfortunates were men who had a severe blockage of cholesterol and a blood clot in the major artery of their heart, their condition often unrecognized until the blockage was complete, and destroyed the heart muscle beyond repair. The result was a heart attack, often resulting in sudden death from abnormal electrical changes in their scarred heart muscle, or a chronic heart muscle malady, a condition known as congestive heart failure.

I have spent the last 40 years chasing the Widowmaker. The advances in the knowledge and success of how to treat and prevent the heart attack have been breath-taking. My career on the “frontline” of the emergency room and the cardiac care unit has brought me enormous satisfaction, allowing me to save so many lives and also educate younger physicians in the science and art of cardiology. But I didn’t think I was finished. I want to share my knowledge with as many people as possible.

Often medical facts are too cold and abstruse for the uninitiated in the medical sciences to absorb and apply to their own lives and care. Below are some key things you need to be aware of so you can remedy the malady, avoid the Widowmaker, and maintain good health.

Three untold signs that are overlooked that could be critical warning of arteriosclerosis of the heart’s arteries:

Mild heaviness in the chest, neck, or both arms either at rest or with exertion.

Shortness of breath with your normal activities.

Intermittent fluttering of the heart felt in your chest.

The role cholesterol plays in atherosclerosis:

We can’t live without cholesterol! It serves as the building block for the walls of the cells of the body; but too much ends up inside of arteries, like spackling compound on drywall. It’s this buildup that leads to blood clots forming that eventually will completely shut off blood flow and result is a heart attack. Cholesterol buildup comes from two sources – our diet and our genetics.

Three ways to lower cholesterol and blood pressure:

Eat better! Much less salt, less fat and carbohydrates—just less calories.

Exercise has so many great effects on health, but you need to get your heart rate up and sweat!

For many of us, medications are needed. They work as long as we take them regularly.

If your doctor orders a stress test, you should ask these 3 questions:

What exactly will the doctor learn about my heart from the test? Is there a blocked artery causing my symptoms, or not?

How accurate are the stress tests? Might I need more testing after the stress test, and if so, what tests would be necessary?

If I have an orthopedic problem, is there another test that could be done so that I don’t need to exercise and risk injury to my hip, knee, back, or ankle?

Anyone who is concerned about the heart health of themselves, a friend, or a loved one will benefit greatly by knowing this history and science of the human heart. I give much credit to the young patient proactively addressing his potential fate of his father. My potions will bludgeon his high blood pressure and drain the dreaded cholesterol from his blood. His heart will be protected.

Arnold Meshkov, MD, is a cardiologist, heart health expert, and was a professor of medicine at Temple University School of Medicine until 2015 when he returned to private practice. He is Board Certified in Internal Medicine, Cardiology and Echocardiography and has lectured on a broad range of topics in cardiology and bioethics, both locally and nationally. 

The views expressed in the article represent those of the author, not necessarily those of the publication.

Clinicians and experts interested in responding to this piece, or submitting their own articles to

A longtime clinician writes on the signs and risks of fatal heart attack events, including the Widowmaker.

Heart Education: Knowledge Saves Your Life

Arnold B. Meshkov MD, FACC

American Academy of Dermatology (AAD) Annual Meeting

 team sat down with assistant professor adjunct dermatology Brittany Craiglow, MD, of the Yale School of Medicine, who highlighted recent positive phase 3 results of baricitnib for adolescents aged 12 - 17 with severe 

In this interview, Craiglow was asked about the study’s primary endpoints and the team’s most notable findings presented at the AAD 2025 meeting. These findings were the 36-week efficacy and safety results drawn from the adolescent cohort of BRAVE-AA-PEDS, a placebo-controlled analysis that is ongoing and assesses children ≥6 years and adolescents 12 to <18 years of age who are suffering from severe alopecia areata.

New Data on Hair Regrowth in Severe Alopecia Areata Using Baricitinib, with Brittany Craiglow, MD

“So this was a clinical trial of baricitinib for severe alopecia areata in adolescents, so patients ages 12 - 17, and the design was very similar to the adult clinical trials that led to the approval of baricitinib for severe AA back a few years ago now,” Craiglow said. “So patients had to have a SALT score of at least 50, which is 50% scalp hair loss. But it was a very severe group of patients. Their average salt score was around 90, so many of these patients had absolutely no scalp hair. Patients were randomized to either baricitinib, 4 milligrams, 2 milligrams, or placebo, and then they were followed for 36 weeks, and that's where the primary endpoint was.”

In terms of the team’s primary endpoints, Craiglow noted that they evaluated the percent of patients who attained a Severity of Alopecia Tool (SALT) score of 20 or less, which represents 80% or more coverage with scalp hair. By the 36-week mark, Craiglow commented that a significantly higher proportion of those in the baricitinib treatment arm versus placebo were able to achieve a 50% and 90% SALT improvement.

“Patients on the 4 milligram dose, or over 40% of those patients actually met that end point, which is really exciting,” Craiglow explained. “You know, this is a population where AA is kind of hard for everybody. But I think we can all look back on our adolescents and think about what that was like, even without alopecia, and we can imagine what it might be like to be a kid navigating life without hair, eyebrows, eyelashes, etc.”

For additional information on this topic, view the full video interview posted above. To find out more from AAD 2025, view our 

The quotes used in this summary were edited for the purposes of clarity. Craiglow has reported personal fees from AbbVie, Concert Pharmaceuticals, Incyte, Eli Lilly and Company, Pfizer, Regeneron, and Sanofi-Genzyme.

Passeron T, Soung T, Ohyama M, et al. Baricitinib Provides Significant Hair Regrowth in Adolescents With Severe Alopecia Areata: 36-Week Efficacy and Safety Results From a Phase 3 Randomized, Controlled Trial. Presented at the 2025 American Academy of Dermatology (ADA) Annual Meeting. Orlando, FL. March 07-11, 2025.

Lilly's baricitinib delivered high rates of hair regrowth for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS study. Eli Lilly and Company. Maerch 8, 2025. 

https://investor.lilly.com/news-releases/news-release-details/lillys-baricitinib-delivered-high-rates-hair-regrowth

In this interview at AAD 2025, Craiglow speaks on her team’s late-breaking findings on baricitinib among adolescents with severe alopecia areata.

Brittany G. Craiglow, MD

A method using solid-phase microextraction–liquid chromatography-mass spectrometry (SPME-LC-MS) was able to detect fatty acids and similar lipids that may help differentiate patients with psoriasis and 

. This is according to a small study published in

In this Q&A, corresponding author Vinod Chandran, MBBS, MD, DM, PhD, associate professor at the University of Toronto and director of the psoriatic arthritis program at the Schroeder Arthritis Institute in Toronto, discussed the research and its findings.

The researchers aimed to develop an LC-MS method to be used in combination with SPME to analyze fatty acids and similar molecules. They tested 25 chromatographic methods based on published lipid studies on two LC columns. As a proof of concept, serum samples from 27 patients with psoriasis (51% female, mean age 43 years), 26 patients with PsA (46% female, mean age 47 years), and 25 health controls (40% female, mean age 48 years) were processed using SPME and run on LC-MS. The best method for analyzing fatty acids and fatty acid-like molecules identified 18 compounds that were statistically significant between patients with psoriasis and those with PsA.

Approximately a quarter of patients with psoriasis have PsA. There is strong interest in discovering predictive biomarkers for patients with PsA among those with psoriasis, to shorten the time to diagnosis and management.

Metabolomics provides a powerful platform for identifying biomarkers for a complex, multifactorial disease such as PsA. Previous studies have reported examples of lipid dysregulation in serum taken from patients with PsA. Additionally, the high prevalence of metabolic syndrome and cardiovascular events in these patients makes lipids of key interest in psoriatic disease.

We sought to develop a metabolomics method using SPME-LC-MS to analyze serum lipids and identify any significant differences between patients with PsA and those with psoriasis.

What were the surprises from the findings?

The method we developed and optimized was capable of detecting lipids. Several classes of lipids such as acylcarnitines, lysophospholipids, and sphingolipids were significantly different between the patients with psoriasis and those with PsA. Specific focus was placed on valerylcarnitine, due to its confirmed identity using tandem mass spectrometry.

This is preliminary data that provides a good direction for future research in lipid biomarker discovery in psoriatic disease. We have developed and optimized a method that can be used on additional samples in a more expansive follow-up study.

What is the current practice and how could the findings possibly change things?

Currently, PsA is diagnosed in patients with evidence of an inflammatory articular disease, who meet certain clinical, laboratory, and imaging criteria. Patients with psoriasis are often screened at appointments with a dermatologist or general practitioner for signs of inflammatory arthritis.

Discovering accurate and reliable biomarkers for PsA could improve the ability of clinicians external to the field of rheumatology to identify patients with PsA. This may lead to prompt referral to a rheumatologist and early diagnosis and management of PsA by a rheumatologist.

What are the takeaway points for clinicians?

Emerging ‘omics’ sciences such as metabolomics have the potential to identify biomarkers that may aid in improving the diagnosis of PsA. Serum lipids such as valerylcarnitine have been found to be dysregulated in PsA. However, further research is needed to develop a biomarker panel to aid in clinical decision-making.

Koussiouris J, Looby N, Kulasingam V, Chandran V. A Solid-Phase Microextraction-Liquid Chromatography-Mass Spectrometry Method for Analyzing Serum Lipids in Psoriatic Disease. 

. 2023;13(8):963. Published 2023 Aug 20. doi:10.3390/metabo13080963

In this Q&A, Vinod Chandran, MBBS, MD, DM, PhD, discussed a method to analyze biomarkers that may differentiate patients with psoriasis and psoriatic arthritis.

Q&A: The Role of Metabolomics in the Diagnosis of Psoriatic Arthritis

Katie Robinson

A subgroup analysis of the ICONIC-LEAD study had its findings presented at the World Congress of Pediatric Dermatology Annual Meeting, demonstrating that adolescents living with 

 given once-daily treatment with icotrokinra (JNJ-2113) saw increased rates of clear or almost clear skin at 16 weeks versus placebo.

After these data were released by Johnson & Johnson, the 

 editorial team interviewed Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and professor of dermatology and pediatrics at the UC San Diego School of Medicine, who had been an investigator in this analysis. Here, Eichenfield highlights the study’s 

 and their significance for dermatologists.

Significance of Icotrokinra Findings for Adolescents with Psoriasis, with Lawrence Eichenfield, MD

“I think my big takeaway is that we have incredibly potent results in terms of this drug, with an incredibly good safety profile as well,” Eichenfield explained. “An easy number to walk away with is that there was almost 90% of patients made PASI 90 at 24 weeks, so we didn't even show PASI 75 data…It was 86.6% of patients at 24 weeks, it was 70.5% at the earlier time point of 16 weeks, and very low placebo response rate at 16 weeks.”

In the team’s other primary endpoint, which was an Investigator's Global Assessment (IGA) score of 0/1 (clear or almost clear skin) with a 2-grade improvement at least, 84.1% of subjects at the 16-week mark and 86.4% at the 24-week mark reported such a response.

“You have to mention the safety as well, and the data set is very consistent,” Eichenfield said. “The overall study population data set was as well, which [means there were] not a lot of remarkable adverse events. There happened to be 2 serious adverse events in the adolescent group, but neither of them was considered secondary to the drug. One patient temporarily stopped the drug and went right back on it. Another 1 had been hospitalized for an evaluation, but it was not related to the drug and never stop the drug. Otherwise, it was an unremarkable side effect profile.”

Eichenfield was asked about what these results should mean to dermatologists and health care professionals reviewing the data from his team’s analysis.

“The big picture is that this technology has set up essentially biologic-like efficacy in an oral agent,” Eichenfield explained. “Certainly for adolescent psoriasis with this particular drug, in this particular peptide, I think having the ability to get such rapid effectiveness with a great safety profile, without the need for injectables, and without concerns about blood work, it's really going to be incredibly well received by the dermatology community.”

View the full video posted above to find additional information on this segment of Eichenfield’s interview.

The quotes implemented in this summary were edited for the purposes of clarity. Eichenfield is a paid consultant for Johnson & Johnson.

Icotrokinra results show 75% of adolescents with plaque psoriasis achieved completely clear skin and demonstrate favorable safety profile in a once daily pill. Johnson & Johnson. April 10, 2025. Date accessed: April 11, 2025. 

https://www.prnewswire.com/news-releases/icotrokinra-results-show-75-of-adolescents-with-plaque-psoriasis-achieved-completely-clear-skin-and-demonstrate-favorable-safety-profile-in-a-once-daily-pill-302425136.html

This segment of the latest interview with Lawrence Eichenfield, MD, features a discussion about the ICONIC-LEAD study.

Lawrence Eichenfield, MD

01:43 Treatment landscape of rheumatoid arthritis

08:30 Use of TNFi in rheumatoid arthritis

12:33 Switching from TNFi in rheumatoid arthritis

20:16 Variations in the use of step therapy between states

27:09 Administrative burden of step therapy

32:20 Processing of exceptions to step therapy protocols

33:44 Step therapy in rheumatoid arthritis

36:45 Impact of staying on ineffective RA treatments

41:20 Use of molecular signature response classifier (MSRC) in RA

42:58 Step therapy and use of molecular signature response classifier (MSRC) test in clinical practice

46:12 Advice for patients and HCPs in navigating step therapy protocols

In this MEDcast episode, Drs Soloman, Sharobeem, Boone and Feldman discuss the use of step therapy in rheumatoid arthritis, how step therapy was intended to be used, how it is actually used, and challenges and solutions to its use.

Challenges With Step Therapy Protocol in Treating Rheumatoid Arthritis

Madelaine Feldman MD, FACR

 Tonight, we're going to spend a little bit of time talking about an overview of age-related macular degeneration, diabetic macular edema, and then dive into some issues about improving outcomes through scientific innovation and focus specifically on faricimab or Vabysmo. As you all know, these are enormous public health issues. Neovascular AMD is the leading cause of precipitous visual loss in people over 60 in the United States, and diabetic macular edema contributes significantly to diabetic blindness, which is the leading cause of blindness in working-age Americans. Treatment with intravitreal anti-VEGF or VEGF inhibitors is the standard of care for both of these conditions, that is exudative AMD and diabetic macular edema. They're extraordinarily effective, but there are some barriers to outcomes that we're going to go over right now.

In the frame to your right, you can see an eye with diabetic macular edema, and this eye has most of the features of non-proliferative diabetic retinopathy, including hemorrhages, microaneurysms, exudates, and cotton wool patches, suggesting ischemia and edema. If you look closely at the center of the macula, you can see some early swelling in that color from this photograph. The question is, do patients in our clinics achieve the vision gains that we see in these clinical trials that Dr. Wells is going to explain to you shortly?

There are a number of papers and [research] projects that have looked at real-world medicine, real-world outcomes in patients with neovascular or exudative AMD. What they've shown is that eyes with this condition receive fewer injections in the real world than they do in the clinical trials. What does that mean? That means that patients in your office or in your local retina specialist's office should be getting a shot every month for years. But instead, what we know is that in the first year, only very few patients achieve an injection index that is a number of shots per year that's above, say, 10. Certainly very few get 12 or 13, and the majority achieve something like 7. And so why is that important? This is a paper from Tom Chula, and this is from pulled data that's anonymized from a number of retina offices. This type of data has been validated from the IRIS database from the American Academy of Ophthalmology and from Verona Health. It's been validated in Europe by a seminal publication by Frank Holtz, who showed that country by country vision goes down with a lower mean number of injections.

What are the challenges that patients encounter for monthly injections? Well, there are many. Some patients are just plain old non-compliant and some patients are very compliant. Patients encounter transportation issues, comorbidities. They're too sick to come in. They don't understand why they need to come in. It's expensive to come in. Travel may be expensive, co-pays may be expensive, and painful injections or fear of injections. There are also some challenges on the provider side. The provider needs to really engage patients around compliance, and that's something that we do a very strict job of. In practice in particular, most of the patients are monocular and many of them are physicians and many of them have failed to treat and extend in their first eye, and with AMD, they just don't catch up. If you treat and extend them and they lose vision or you PRN them and they lose vision, going back to monthly usually doesn't rescue them, at least in my experience. So we tend to be program monthly treaters, particularly for second eyes and particularly for eyes that are at risk and active. And that tends to be a lot of our patients at a tertiary center. But we do find the phenomenon that when we get patients seeing better they want to come in so we're not selling them on compliance we're selling them on better vision. And so these this is a set a typical set of challenges that patients encounter for a monthly injection burden.

Now, this leads to the second point of patients under clinic have suboptimal vision gains. And so, some years ago, novel therapies were looked at beyond just inhibiting vascular endothelial growth factor. And one of the pathways that was looked at inhibits angiopoietin 2, and the attempt to make more durable clinical effects with longer intervals between treatments and excellent safety, and in our hands, and Jack is going to talk to you all about this better vision.

Transcript is AI-generated and edited for clarity and readability.

Steven D. Schwartz, MD, reviews challenges and unmet needs in treatment of patients with neovascular AMD and DME.

Overview of Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema

Steven D. Schwartz, MD

Data on JAK Inhibitor Safety for Those Pregnant or Breastfeeding, with Tina Bhutani, MD

 in Orlando, a presentation titled ‘Alopecia Areata: New Therapies’ featured University of California, San Francisco clinical researcher Tina Bhutani-Jaqcues, MD, who spoke with the 

The topic of Janus Kinase (JAK) inhibitors and guidance on implementation among patients with 

 during pregnancy or breastfeeding was highlighted by Bhutani in her interview. Bhutani was asked about some of the biggest takeaways from the talk at AAD.

“I encourage, if you do have a patient who for whatever reason does become pregnant while on these medications or decides that they still want to breastfeed, despite the limited amount of data, to actually report this to the to the FDA and the company at large, so that we can track this data,” Bhutani said. “There are also registries. There's a registry called ‘MotherToBaby,’ and they track the effects of medications on pregnancy and lactation. So using those kinds of resources can help others, help to increase the numbers of patients that we have, and increase our confidence in using these medications in this population.”

Bhutani also highlighted several unique findings covered in her talk regarding JAK inhibitors and birth control among women.

“The other concern that comes up when we're treating women of reproductive potential is the question about birth control,” Bhutani said. “So we know that, for example, oral contraceptive pills can increase clotting risk in some patients, especially women who are age over the age of 35, especially if they're smokers and things of that sort. One of the concerns in that black box warning was the risk of venous thromboembolism or blood clots. So the question becomes if we combine JAK inhibitors with birth control, is that a double hitter, and are these women going to be at increased risk for blood clots? And the answer is actually no, not from the data that we see.”

Bhutani noted that these types of findings contribute to the safety profile of JAK inhibitors used for alopecia areata. She highlighted research on rheumatoid arthritis during which patients were allowed to continue birth control, with the results indicating that the risk of venous thromboembolism was not increased.

Later, Bhutani was asked about additional studies she highlighted in her talk. She noted an additional analysis that she felt was worth mentioning.

“I think one unique thing that [also] I found was that for deucravacitinib…in the animal studies, [investigators] actually didn't see any issues with the drug either crossing into the placenta or causing any abnormalities,” Bhutani said. “So I think it just it begs the question ‘Should it really be in the JAK family’ and ‘Is it a different type of protein?’”

For additional information on this topic, view the full video interview posted above.

The quotes contained in this summary were edited for the purposes of clarity.

This AAD 2025 interview with Bhutani covers some of the takeaways from her presentation on use of JAK inhibitors for alopecia areata among pregnant or breastfeeding women.

Tina Bhutani, MD

Aflibercept 8 mg Shows Durability at 3 Years in Wet AMD with W. Lloyd Clark, MD

Aflibercept 8 mg (EYLEA HD) achieved positive results at 3 years among patients with 

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

 in an extension study of the Phase 3 PULSAR trial.

Announced by Regeneron Pharmaceuticals on February 8, 2025, these findings, presented at Angiogenesis, Exudation, and Degeneration 2025, revealed most patients treated with aflibercept 8 mg continued to experience improvements in vision and anatomy, with extended dosing intervals.

“In the PULSAR extension, a large percentage of patients can be extended out to 4 months or even longer, with good disease control,” W. Lloyd Clark, MD, Palmetto Retinal Center, and assistant clinical professor of ophthalmology at the University of South Carolina School of Medicine told 

“This really does represent the next incremental improvement in the chronic treatment of patients with wet AMD.”

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

 Wet AMD occurs after the growth of abnormal blood vessels leak fluid under the macula, with nearly 1.4 million people in the US at risk of vision loss from AMD.

The PULSAR trial was a double-masked, active-controlled pivotal trial in patients with wet AMD, reporting 88% of all patients on aflibercept 8 mg maintaining ≥3-month dosing intervals at the end of 2 years. After its completion, an optional extension study began at Week 96, with all participants receiving aflibercept 8 mg across Week 156. Dosing intervals in the extension study could be reduced or extended by 2-week increments based on certain criteria, with a minimum interval of every 2 months and a maximum of every 6 months.

Among those who completed the full 3 years of treatment (n = 375), nearly 60% had a last assigned dosing interval of ≥4 months. Approximately 40% and 24% had a final assigned dosing interval of ≥5 months and 6 months at the end of 3 years. Visual and anatomic improvements, including reductions in retinal thickness, were sustained through year 3 in the extension.

Those in the comparator arm were treated with aflibercept (EYLEA) as a fixed 2-month dosing regimen for 96 weeks and could switch to a 3-month dosing interval with aflibercept 8 mg until Week 156. Among those who completed the extension (n = 186) after switching, these data showed maintenance of vision and anatomic improvements, with 79% and 43% on an assigned dosing interval of ≥3 and ≥4 months, respectively.

The safety of aflibercept 8 mg was similar to aflibercept across 3 years and remained generally consistent with the known profile from pivotal trials. Ocular treatment-emergent adverse events (TEAEs) were reported in ≥4% of all patients, including cataracts, retinal hemorrhage, reduction of visual acuity, vitreous floaters, and increase of intraocular pressure. The rate of intraocular inflammation was 2.4% for the patients who switched from aflibercept to aflibercept, and 1.9% for those randomized at baseline.

“These patients typically stay on treatment for life and I’ve got patients in my clinic that have been on injections pushing 20 years,” Clark told 

. “If we can reduce the number of treatment visits for these patients, it will significantly increase their quality of life. These patients with wet AMD are typically more compliant and so they welcome the idea of coming less frequently.”

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

Three-year results for Eylea HD® (aflibercept) injection 8 mg in patients with wet age-related macular degeneration demonstrate continued durable vision gains and anatomic improvements with extended dosing intervals. Regeneron Pharmaceuticals Inc. February 8, 2025. Accessed February 20, 2025. https://newsroom.regeneron.com/news-releases/news-release-details/three-year-results-eylea-hdr-aflibercept-injection-8-mg-patients.

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

Ruia S, Kaufman EJ. Macular Degeneration. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560778/

Clark describes visual and anatomic improvements with aflibercept 8 mg in the PULSAR extension study, with most patients achieving extended dosing regimens.

W. Lloyd Clark, MD

Geoffrey Grammer, MD closes this series highlighting the administration options of esketamine, its safety profile, and the importance of monitoring patients using this treatment.

Authors