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The diabetic macular edema section is a comprehensive resource for Ophthalmology news and expert insights. Read more at Modern Retina.

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Clinical Focus

Ashvattha announces positive topline data for MGB for the treatment of DME and nAMD

A study reveals significant treatment burdens for patients with AMD and DME, highlighting the need for improved education and support to enhance outcomes.

An eye on how patients perceive their retinal disease

VivaVision Biotech welcomes renowned ophthalmologist Quan Dong Nguyen to its scientific advisory board with hopes of boosting innovation in ocular disease therapies.

VivaVision Biotech appoints Quan Dong Nguyen to its scientific advisory board

Sandoz will oversee commercialization of the product across the European Union (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia under the terms of the agreement.

Lupin and Sandoz sign licensing deal for biosimilar ranibizumab across multiple regions

4D Molecular Therapeutics showcases promising SPECTRA trial results for 4D-150, highlighting its potential to revolutionize diabetic macular edema treatment.

4DMT reports positive SPECTRA results in DME trial

At EURETINA 2025, Stela Vujosevic, MD, PhD, FEBO asks, "as part of the symposium on diabetes and vascular disease, "Do we need a new staging for diabetic retinopathy and macular edema?"

As imaging modalities improve, so do clinicians' understanding of disease. But some parts of the clinical landscape need to keep better pace with innovation in technology and technique. This argument was key to a lecture from Stela Vujosevic, MD, PhD, FEBO, who is the head of medical retina at IRCCS MultiMedica in Milan, Italy. She presented during the European Society of Retina Specialists (EURETINA) as part of the symposium on diabetes and vascular disease." Her presentation title posed a question: "Do we need a new staging for diabetic retinopathy and macular edema?"

Prof. Vujosevic answered in the affirmative. The staging system for diabetic retinopathy (DR) and diabetic macular edema (DME) has not caught up with advancements in imaging or image analysis, Prof. Vujosevic said. 

"The current staging system does not completely reflect the status of the neovascular unit in the retina," she said. "We need a novel and, I would say, more inclusive staging system for both DR and DME." Prof. Vujosevic provided the example of hyperreflective foci, a sign of inflammation and activation of microglial cells. These biomarkers can be assessed with optical coherence tomography (OCT), and provide an idea of the prognosis of a patient's diabetic eye disease. Advanced biomarkers, now detectable with OCT and high-res OCT, should be a foundational aspect of the next generation of staging for DME and DR. 

The revisions to current staging models do not end with imaging—they include patient-reported qualitative data as well. "We definitely need to integrate all of these imaging modalities into the staging system, and obviously not forget the patient's point of view," Prof. Vujosevic continued. "Quality of life and patient-reported outcome measures are also very important to understand better how and when to treat these patients."

Watch the video to hear Prof. Vujosevic delineate the benefits of staging, including earlier diagnosis and the potential for support from regulatory bodies to help patients access earlier treatment.

Videos

During the EURETINA session, Stela Vujosevic, MD, PhD, FEBO, posed questions about the current staging for diabetic macular edema and diabetic retinopathy.

EURETINA 2025: Why the current staging for diabetic eye disease is obsolete

End-of-Study Results From a Phase 2 Trial of EYP-1901

At the 2025 American Society of Retina Specialists (ASRS) meeting in Long Beach, California, Yasha S. Modi, MD, associate professor of ophthalmology at NYU Langone, presented end-of-study results from the phase 2 VERONA trial. This study evaluated EYP-1901, a bioerodible intravitreal implant containing vorolanib, a tyrosine kinase inhibitor (TKI), as a potential treatment for diabetic macular edema (DME), compared to the standard anti-VEGF agent aflibercept.

Modi highlighted that the VERONA trial demonstrated promising outcomes, showing stability in both visual acuity and anatomical measures out to week 24. Two doses of EYP-1901 were tested, and the higher 2.7 mg dose appeared to deliver superior results. These findings support advancement to a phase 3 trial, which is expected to proceed with this higher dose, although full trial details have not yet been disclosed.

TKIs such as vorolanib offer a novel approach by blocking VEGF receptors intracellularly, leading to a pan-VEGF suppression. This mechanism may allow for greater durability of effect—potentially extending dosing intervals to six months—compared to current therapies. Modi noted the growing landscape of TKI-based treatments as a positive development, offering retina specialists more options for personalized patient care.

A notable feature of EYP-1901 is its delivery system. Administered in-office via a 22-gauge needle, the bioerodible implant is gradually absorbed, reducing long-term intraocular burden. This convenience and compatibility with existing clinical workflows make it an attractive option for both physicians and patients.

ASRS 2025: End-of-study results from VERONA, a phase 2 trial of EYP-1901

Dilsher S. Dhoot, MD, discusses how newer anti-VEGF treatments, particularly aflibercept 8 mg, can provide improved anatomic outcomes and extended treatment intervals for patients with neovascular age-related macular degeneration who show persistent subretinal fluid despite treatment with first-generation agents.

Improved Retinal Drying and Treatment Durability In nAMD With Aflibercept 8 mg

Video content above is prompted by the following: 

The first episode discusses case-based roundtable findings from retina specialists and residents regarding neovascular age-related macular degeneration (nAMD) treatment. Dilsher S. Dhoot, MD,

from California Retina Consultants, presents multiple cases showing the efficacy of second-generation anti-VEGF therapies. The first case highlights a patient with persistent subretinal fluid despite bevacizumab treatment who showed improvement after switching to aflibercept 8 mg, demonstrating both improved durability and efficacy with treatment intervals extending to 8 weeks.

A second case presents a patient with bilateral nAMD and pigment epithelial detachments (PEDs) who responded exceptionally well to aflibercept 8 mg in both eyes, achieving near-resolution of PEDs and complete resolution of intraretinal fluid. The panel discussed different treatment approaches, with some physicians preferring three loading doses before extension while others treated to dryness before immediately extending treatment intervals. The importance of discussing retinal pigment epithelial tear risks with patients having large PEDs was emphasized.

Additional cases demonstrated aflibercept 8 mg’s effectiveness in patients with suboptimal responses to first-generation therapies. One patient with a fibrous PED and subretinal fluid showed marked improvement after switching from bevacizumab to aflibercept 8 mg, with vision improving from 20/100 to 20/50. The final case illustrated that while some patients respond well to first-generation therapies like aflibercept 2 mg, careful monitoring is necessary as durability may be limited, with reactivation of subretinal fluid requiring consistent treatment.

Video Series

Dilraj S. Grewal, MD, FASRS, Associate Professor of Ophthalmology - Duke University School of Medicine - Durham, North Carolina, discusses New Therapeutics for Non-infectious Uveitis in 2025

New Therapeutics for Non-infectious Uveitis in 2025

Dilraj S. Grewal, MD, FASRS, an associate professor of ophthalmology at Duke Eye Center, provides an in-depth overview of the current state of research and treatment innovations. 

"It's an exciting time to be in uveitis," Grewel said. "You know, we've always seen our colleagues getting exciting clinical trial data for macular degeneration and diabetes, and yet, uveitis remains 10% of all blindness in the United States, even today. So there's a large unmet need to have therapies that go just beyond steroids or beyond what we have in our systemic armamentarium currently, which is mainly anti-metabolites and biologics."

Current clinical trials are exploring multiple treatment strategies, including systemic, local, intravitreal, and topical interventions.

So we're very fortunate to have a spectrum of clinical trials that are currently under various stages," he continued. 

"We're looking at systemic therapies, looking at local therapies, intravitreal, as well as looking at topical therapies. And the unifying theme here is to provide control of disease activity without having the associated side effects that steroids bring with them. 

"That's extremely important, because in the midst of a busy retina clinic, we often tend to ignore subtle signs of inflammation, or we don't fully evaluate inflammation in our patients that have uveitis. And we learn a lot from clinical trial design, as well, the importance of, for example, wide-field fluorescein angiography to fully characterize the extent of leakage, because leakage is a very defining marker of intraocular inflammation. And if you look at some of the trials that are out there right now, for example, brepocitinib, which is an oral JAK1 TYK2, small molecule inhibitor, and has shown positive results in the phase 2 NEPTUNE study.

Ophthalmologist Dilraj Grewal explores cutting-edge clinical trials for uveitis treatment, highlighting new targeted therapies that aim to control inflammation and macular edema with fewer steroid-related side effects.

Innovative uveitis therapies: targeting inflammation, macular edema

Four-year study shows faricimab in treat-and-extend regimen maintains vision for diabetic macular edema patients with significantly fewer injections over time.

Faricimab Reduces Injections, Maintains Vision in DME

Matt Star, MD, assistant professor of ophthalmology and the Program Director of the residence program at the Mayo Clinic, discusses the RHONE-X trial. RHONE-X is a long-term, multicentered, open-label extension trial of both the YOSEMITE and RHINE trials. It evaluated the use of a treat-and-extend dosing regimen of faricimab for the treatment of 

"It is the first 4-year study of treat-and-extend dosing for patients receiving faricimab for diabetic macula edema," Starr said. "The highlights of that study showed that patients who received faricimab had a treat-and-extend dosing interval had maintained vision and central subfield thickness improvements that were seen in YOSEMITE and RHINE up to 4 years with a significantly fewer number of injections. The median number of faricimab injections in year 4 for all patients was only 3."

Starr said the take home message "is that using a treat-and-extend dosing with faricimab for patients with diabetic macula edema, many patients are able to extend it out to 12 weeks, 16 weeks, and still maintain vision and CST improvements over time."

The study followed nearly 1,500 eyes over 4 years, with an 82% retention rate. Key findings reveal that patients using faricimab maintained significant vision improvements, achieving a consistent 10-letter gain across different initial treatment arms.

"Patients in YOSEMITE and RHINE saw about a 10-letter gain at the end of those study periods, and by the end of RHONE-X, the same letter gain was achieved," he continued. "All patients had about a 10-letter gain at the end of RHONE-X, irregardless of the treatment arm in YOSEMITE and RHINE, whether it was Q8 week aflibercept, Q8 week faricimab, or the treat-and-extend faricimab from the beginning. And so once those patients were then transitioned from those treatment arms into a treat-and-extend regiment, they still maintained those 10-letter vision gains from baseline with about about a 200 micron reduction in CST from baseline as well." 

The study's primary focus was on reducing treatment frequency without compromising clinical outcomes. By demonstrating that patients can maintain vision with fewer injections, the RHONE-X trial represents a significant advancement in DME management, potentially improving patient quality of life by minimizing clinic visits and treatment intensity.

Future research will continue through ad-hoc analyses of this dataset.

RHONE-X trial evaluates extended dosing in DME patients

Carl Danzig, MD, director of vitreo-retinal services at the Rand Eye Institute in Deerfield Beach, Florida, shared an update on his research in OCS-01 drops for diabetic macular edema during ARVO

Carl Danzig, MD, director of vitreo-retinal services at the Rand Eye Institute in Deerfield Beach, Florida, shared an update on his work in diabetic macular edema (DME) during the Association for Research in Vision and Ophthalmology (ARVO) meeting.

In Salt Lake City, Utah, Dr. Danzig explained a drop-based DME treatment called OCS-01 (Oculis Holding), the subject of the ongoing phase 3 DIAMOND trial.

"We all know that diabetic macular edema is a huge unmet need here in the United States and around the world, and it is one of the leading causes of new cases of blindness in the US," Dr. Danzig said. "Furthermore, there's a high treatment burden. The way we treat DME currently is with injections for the vast majority of cases, occasionally laser, but patients don't want to keep up their appointments. There's non-compliance. So, we have to find a way to better address this need."

In the DIAMOND trial, Dr. Danzig said, a new nanotechnology permitted the highly concentrated dexamethasone eye drop to penetrate through the cornea into the posterior segment. "This is the first time that we have an eye drop that comes from the surface of the eye and penetrates into the retina with efficacy," he explained. "They do this through having a longer duration on the corneal surface and the drug's able to enter with the vehicle that goes through the corneal stroma."
"Think of it like passengers on a train," he continued. "We know that getting through the cornea is difficult. So these passengers on the train, the passengers are the drug." The train cars represent the vehicle, and the train passes through a mountain tunnel—the cornea.


"When it exits on the other side, the passengers get out," Dr. Danzig concluded, "That's the drug, getting out into the anterior segment and then going through to the posterior chamber."

He went on to explain findings from the first phase of the two-stage DIAMOND trial. The first stage was a 12-week trial with a primary endpoint at 6 weeks for a best corrected visual acuity (BCVA) gain. Patients were either treatment-naive or treatment-experienced, with an entrance vision of 24 to 65 ETDRS letters. Patients received either OCS-01 eye drops six times a day for 6 weeks, followed by a maintenance phase of three times per day. Other patients, randomized 1:1 to the vehicle, received just the vehicle at the same frequency—an "empty train car," in Dr. Danzig's analogy. 

"What we saw in the clinical trial was an increase in BCVA as early as week 2 in the OCS-01 treatment arm that was increased, that increased further at week 6, and then was maintained until week 12 [with a] 7.6 letter gain," he explained. "So you had six times a day of an eye drop for 6 weeks, followed by three times a day. That gain that was seen at 6 weeks. When you decrease the eye drop to three times a day, that gain was maintained." Investigators reported rapid decrease in central subfield thickness (CST) as early as week 2, and those findings were maintained throughout the end of the 12-week study. 

"When you look at lens status—because this was an important thing to look at, phakic and pseudophakic patients—Whether you were phakic or pseudophakic, you had BCVA gains and CST reductions," he said. "There was no increase of cataract formation at week 12, when we look at safety signals, there were no new or unexpected safety signals seen." Based on all of these positive findings, Dr. Danzig said, investigators have moved on to a stage 2 of the phase 3 study. This new stage will examine the DME treatment over 52 weeks, and that stage is now fully enrolled as of April.

According to Dr. Danzig, the DIAMOND trial demonstrates efficacy of OCS-01, a topical drop, in patients with diabetic macular edema.

ARVO 2025: Carl Danzig, MD, recaps the first stage of a phase 3 study of drop-based DME therapy

ARVO 2025: Rishi Singh, MD, discusses real-world clinical outcomes in patients with DME

At the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, the Eye Care Network spoke with Rishi Singh, MD, vice president and CMO, Cleveland Clinic Martin North and South Hospitals. At the meeting in Salt Lake City, Utah, Dr. Singh presented a poster highlighting the real-world durability of faricimab in patients with diabetic macular edema (DME), using data from the IRIS Registry. 

The study analyzed nearly 1,200 eyes and found improvements in the annualized number of injections for both previously treated and treatment-naive patients. "We found that in both the previously-treated eyes and the treatment-naive eyes, that there was a improvement in the annualized number of injections they received," Dr. Singh said. "We also saw a stability of those patients who were previously treated in regards to the visual acuity, and we saw an improvement in visual acuity in those patients who were previously treatment-naive."

Additionally, retinal thickness among patients with DME reduced by almost 60 microns from baseline, with no significant intraocular inflammation. "Always, the safety has remained very top notch and without any significant intraocular inflammation or any other serious conditions," Dr Singh said. "This, again, is validated in a real-world population."

In an analysis of the IRIS database, investigators assessed almost 1,200 eyes that had been treated with faricimab.

4.	David Eichenbaum, MD, FASRS concludes this series with the final case of a patient switching from aflibercept 2 mg to high-dose aflibercept 8 mg.

Case 2: Treatment-Experienced nAMD Switch to Aflibercept 8mg

David Eichenbaum, MD, FASRS presents the second case, wrapping up with key insights from the cases in this series. The second case involved an 88-year-old patient with neovascular macular degeneration, initially treated with aflibercept 2 mg every 5 to 6 weeks. The patient had good outcomes, but Eichenbaum sought to improve both anatomy and visit frequency. The patient was switched from aflibercept 2 mg to aflibercept 8 mg. After the first injection, there was a notable improvement in anatomy and visual acuity. Subsequently, the patient was extended to an 8-week interval, showcasing positive outcomes.

Regarding the choice between aflibercept 8 milligrams and faricimab, Eichenbaum finds it challenging, expressing that both are excellent drugs. He hopes for clearer guidance on which patients may benefit more from one over the other. In his practice, that decision often relies on individual patient response to treatment.

This summary was AI-generated and edited for clarity. 

David Eichenbaum, MD, FASRS concludes this series with the final case of a treatment-experienced patient switching from aflibercept 2 mg to high-dose aflibercept 8 mg with noticeable improvement after the first dose. 

3.	David Eichenbaum, MD, FASRS provides his clinical experience with faricimab and aflibercept 8 mg.

Clinical Perspectives Comparing Faricimab and Aflibercept 8mg

David Eichenbaum, MD, FASRS reflects on his experience with faricimab and aflibercept 8 mg, noting that both second-generation agents have shown superiority over first-generation agents like ranibizumab and aflibercept 2 mg. While he acknowledges these advancements as significant, he characterizes them as incremental rather than revolutionary. He emphasizes the importance of these drugs in optimizing care for patients with macular degeneration, particularly in terms of anatomic response and durability, while highlighting the quality-of-life improvements for patients who require frequent care and doctor visits. Eichenbaum believes that these drugs demonstrate differences in both drying ability and durability compared to their predecessors.

He stresses the relevance of real-world experience, especially with treatment-experienced patients who may have different needs than those in registration studies. Overall, he sees these second-generation agents as essential tools for optimizing the treatment of macular degeneration patients.

David Eichenbaum, MD, FASRS provides his clinical experience with faricimab and aflibercept 8 mg, highlighting the small and large changes that benefit a patient’s quality of life, such as improved visual anatomy or reducing the frequency of visits. 

2.	David Eichenbaum, MD, FASRS discusses his clinical experience in managing retinal fluid, emphasizing the need to dramatically reduce intraretinal fluid.

Tolerance and Aggression: Achieving Improved Fluid Response

David Eichenbaum, MD, FASRS shares insights into his approach to treating neovascular macular degeneration, emphasizing the goal of reducing intraretinal and subretinal fluid for optimal visual function and anatomical outcomes. He expresses intolerance for intraretinal fluid, citing evidence that it may have more adverse long-term effects. The physician discusses his aggressive treatment strategy, especially in the early stages of the disease, aiming to maintain dryness. He highlights the importance of a regimen that is not only effective but also tolerable and accessible for patients.

Eichenbaum advocates for early switching to alternative agents in cases of non-response or inadequate durability. He favors second-generation agents like aflibercept 8 milligrams or faricimab, especially when attempting to extend treatment intervals. This patient-centered approach ensures a tailored and proactive plan for managing neovascular macular degeneration, considering both initial response and long-term durability.

David Eichenbaum, MD, FASRS discusses his clinical experience in managing retinal fluid, emphasizing the need to dramatically reduce intraretinal fluid, highlighting different strategies of care that offer the best results for patients. 

11.	Experts conclude the series with the hope that longer-acting agents will lead to better real-world outcomes for patients.

Promoting Treatment Adherence in nAMD and DME

Experts conclude their discussion reflecting on recent therapeutic advancements and novel approaches on the horizon. As the use of longer durability agents increases, there's optimism that patient adherence to treatment will improve, potentially leading to better real-world outcomes compared to clinical trials. Educating patients about the importance of regular follow-ups and the ongoing nature of treatment is crucial for maintaining adherence. Visual aids like OCT scans can motivate patients by showing the reduction of fluid and improvement in their condition over time. Ultimately, fostering patient buy-in early on and providing ongoing support are key to maximizing treatment effectiveness and preserving vision in conditions like neovascular AMD and diabetic macular edema.

This summary was AI-generated and edited for clarity.

Experts conclude the series with the hope that longer-acting agents will lead to better real-world outcomes for patients, mirroring clinical trial results and potentially preventing vision loss, especially in countries with limited access to healthcare. 

Promoting Treatment  Adherence in nAMD and DME

Experts discusses concerns related to intraocular inflammation (IOI) and potential batch variations in biologics faricimab and aflibercept.

Safety Considerations for New Therapies 

Concerns arise with the use of new agents for neovascular AMD and DME, particularly regarding intraocular inflammation (IOI) and batch-to-batch variations inherent in biologics. The clinicians recommend closely monitoring patients for signs of IOI, vitreous cell presence, and other adverse events, especially with high-dose formulations like faricimab and aflibercept 8mg. FDA-mandated labeling changes acknowledging IOI risk reinforce safety measures, although overall risk-benefit ratios remain favorable. The transition from vials to prefilled syringes with higher volumes prompts consideration of potential complications such as increased intraocular pressure, particularly in patients with glaucoma. Techniques like ocular massage and vigilant monitoring help mitigate risks associated with higher volume injections, ensuring optimal safety for patients receiving these newer agents.

Experts discusses concerns related to the use of new agents, focusing on intraocular inflammation (IOI) and potential batch variations in biologics faricimab and aflibercept. He emphasizes close monitoring for IOI and advises clinicians to scrutinize patients for any signs of inflammation during follow-up visits. 

Safety Considerations for New Therapies

9.	Peter Kaiser, MD shares his early experiences with faricimab and high dose aflibercept for nAMD and DME.

Early Real-World Experiences With Faricimab and Aflibercept 8mg

Experts share their clinical experiences using second-generation therapeutics to manage retinal diseases. In early experiences with these drugs for neovascular AMD and DME, the feedback has been generally positive. The use of faricimab, particularly in challenging cases, has shown improvement in around one-third of patients, with another third showing similar outcomes to the previous treatment, aflibercept 2 milligram. High dose aflibercept 8mg has demonstrated efficacy in extending treatment intervals for many patients. While outcomes for the most difficult-to-treat patients are still being assessed by the experts, initial observations suggest improvement, albeit not drastically longer dosing intervals. Overall, the experts anticipate that results will align closely with those of faricimab, with roughly a third of patients experiencing significant improvement and another third seeing comparable outcomes to previous treatments.

Peter Kaiser, MD shares his early experiences with faricimab and high dose aflibercept for nAMD and DME. He notes positive outcomes, especially with hard-to-treat patients, and emphasizes the ongoing evaluation of patient response to treatment.

Peter Kaiser, MD discusses the utilization of newer agents, faricimab and high dose aflibercept.

Patient Selection for New nAMD and DME Therapies

In the provided transcript, the physicians discuss the use of newer agents, such as faricimab and high-dose aflibercept, in the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). They mention that these agents were primarily tested in treatment-naive patients but are also being used in refractory patients who have not responded well to other anti-VEGF treatments. The physicians describe two main scenarios for using these agents: switching patients who are not doing well on their current treatment to a newer agent and attempting to further extend treatment intervals in patients who are responding well but still require frequent injections. They emphasize the importance of individualized treatment approaches and monitoring patient response closely. Additionally, they discuss their experiences with different treatment strategies, including switching between agents and adjusting dosing intervals, based on patient needs and response. The physicians also touch upon the safety profile of these newer agents, highlighting the need for vigilance, especially in the case of brolucizumab, and expressing confidence in the safety of faricimab and high-dose aflibercept based on clinical trial data.

Peter Kaiser, MD discusses the utilization of newer agents, faricimab and high dose aflibercept, for refractory patients who haven't responded well to previous treatments and for patients doing well but aiming to extend dosing intervals. 

Experts discuss the use of steroids, particularly in the context of diabetic macular edema (DME). 

Using Steroids in DME Treatment

Experts discuss the use of steroids in the treatment of diabetic macular edema (DME). They agree that steroids can be beneficial in DME due to its inflammatory nature, especially in patients with persistent fluid despite anti-VEGF treatment. However, they note that steroids are often added later in the treatment course in the United States compared to other countries like Italy and Japan. The physicians acknowledge the potential adverse effects of steroids, such as cataract formation and increased intraocular pressure, particularly in younger patients. Despite these risks, they emphasize the importance of considering steroids earlier in the treatment regimen for DME patients, especially in non-pseudophakic patients, as steroids can target a broader range of cytokines beyond VEGF. They both express support for the use of steroids in diabetic retinopathy or DME, while noting that steroids are not indicated for age-related macular degeneration (nAMD).

Experts discuss the use of steroids, particularly in the context of diabetic macular edema (DME). The inflammatory nature of DME reveals the effectiveness of steroids, especially in cases where persistent fluid remains despite anti-VEGF treatment. 

 Kaiser, MD explains that loading doses may not be necessary based on studies like the CAT study.

Perspectives on Loading Dose and Treatment Extension With New Therapies

The retinal specialists discuss the use of loading doses in the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). They share insights from studies indicating that a loading dose may not significantly impact visual acuity outcomes, referencing the CAT study as an example. The physicians emphasize individualized treatment approaches, such as treating to dryness and using a treat-and-extend regimen based on patient response rather than fixed dosing intervals. They discuss extending treatment intervals based on patient response and the specific characteristics of each disease, highlighting the importance of flexibility and considering patient preferences in treatment decisions. Additionally, they note the complexity of managing these conditions and the need for careful consideration beyond simply administering injections.

Experts discuss the approach to loading doses in the context nAMD and DME. Kaiser, MD explains that loading doses may not be necessary based on studies like the CAT study, while he highlights the importance of individualized treatment plans tailored to the specific needs of each patient and the nuances of different retinal diseases. 

5.	Judy Kim, MD and Peter Kaiser, MD discuss the significance of fluid dynamics in nAMD and DME.

Perspectives on Retinal Fluid Management in nAMD and DME

Experts discuss the management of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) with a focus on fluid management using OCT imaging. They emphasize the importance of distinguishing between different types of fluid accumulation, such as intra-retinal, sub-retinal, and sub-RPE fluid, and its impact on visual acuity outcomes. They highlight findings from studies indicating that intra-retinal fluid is particularly detrimental to visual outcomes in both diseases. Additionally, they discuss the importance of minimizing fluid fluctuations over time to prevent worse visual outcomes and increased fibrosis. The physicians also mention the variability in response to treatment among patients and the need to consider switching treatment agents if necessary, particularly in cases where patients remain wet despite ongoing treatment.

Judy Kim, MD and Peter Kaiser, MD discuss the significance of fluid dynamics in nAMD and DME, highlighting the detrimental effects of fluid fluctuations and emphasize the importance of minimizing these fluctuations to achieve better visual outcomes. 

Experts highlight the importance of adapting trial criteria to clinical practice.

Aligning Clinical Trial Retreatment Criteria to Clinical Practice

Experts discuss the variation in extension and shortening criteria across clinical trials for newer therapies in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Judy Kim, MD cites examples from PULSAR and PHOTON trials, highlighting specific criteria such as visual acuity and central subfield thickness changes for shortening intervals. Peter Kaiser, MD acknowledges the complexity of these criteria and emphasizes the need for standardization in large-scale clinical studies. In clinical practice, Kaiser points out that decisions on shortening or extending treatment intervals are based on a more intuitive approach, considering factors like vision loss, optical coherence tomography changes, and the patient's overall response. Kaiser emphasizes that, unlike clinical trials, where strict criteria are defined, the real-world application involves a more flexible and personalized approach.

The conversation underscores the importance of clinical trial standardization while acknowledging the practical challenges of applying rigid criteria in day-to-day patient care. Experts highlight the need for a personalized "treat and extend" approach based on fluid status, previous durability, and vision outcomes.

Judy Kim, MD and Peter Kaiser, MD reflect on the varying criteria for shortening or extending treatment intervals in clinical trials, emphasizing the need for standardization in large-scale studies. They highlight the importance of adapting trial criteria to clinical practice. 

3.	Experts discuss the efficacy and durability of newer therapies, focusing on faricimab.

Overview of the Newest Therapies for AMD and DME: Faricimab and Aflibercept 8mg

In the discussion on the efficacy and durability of newer therapies for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), Judy Kim, MD and Peter Kaiser, MD focus on two recently approved drugs, faricimab and high dose aflibercept.

Faricimab, a bi-specific molecule blocking both VEGF-A and angiapointin-2, is highlighted for its potential increased durability. Kaiser points out that clinical studies specifically examined this aspect, revealing extended intervals, with around 80% of patients achieving 12 weeks or more, and approximately 45% reaching 16 weeks. He emphasizes that achieving a 16-week interval requires a gradual approach, akin to a treat-and-extend protocol. The discussion transitions to the high dose of aflibercept, with an increased dosage of 8 milligrams, aiming for a 16-week therapy. Similar to faricimab, the high dose of aflibercept demonstrated promising extending intervals in clinical studies, with a small percentage reaching a six-month interval.

Both physicians express excitement about the potential for these newer agents to push treatment intervals to 12, 16, or even 24 weeks while maintaining vision results comparable to the traditional eight-week interval with aflibercept. They stress that patients should be guided towards these intervals gradually and underscore the importance of not compromising efficacy in the pursuit of extended durability.

Experts discuss the efficacy and durability of newer therapies, focusing on faricimab and the high dose of aflibercept, highlighting the promising clinical trial results, maintaining comparable visual acuity efficacy while achieving longer durability

Experts discuss their drug preferences and highlight the evolving landscape, emphasizing the need for collaboration.

Role of Biosimilars in nAMD and DME Step Therapy

Experts shift their focus to biosimilars in the market, particularly the biosimilar ranibizumab. Peter Kaiser, MD highlights their safety and efficacy comparable to the reference ranibizumab. Despite being on formulary, Kaiser expresses a preference for other agents, such as bevacizumab and aflibercept, for patients with macular degeneration. The conversation touches on the potential shift in attitudes towards biosimilars, especially with the impending entry of a biosimilar aflibercept into the market. Kaiser emphasizes that he would likely use a biosimilar aflibercept when available, citing a thorough examination of biosimilar data and expressing confidence in their approval process.

The discussion takes an interesting turn as Kaiser introduces the "supermarket problem," likening the to the limited shelf space in a supermarket to the limited fridge space in clinic. Kaiser expands on this analogy, emphasizing the need for strategic choices in stocking available treatments. They discuss the increasing complexity of treatment decisions with a growing array of available drugs.

The conversation concludes with a recognition of the challenges posed by barriers like step therapy. Experts emphasize the importance of collaboration between medical societies, such as the American Society of Retina Specialists, and insurance companies, to address treatment barriers and work towards the benefit of patients.

Judy Kim, MD and Peter Kaiser, MD discuss the use of biosimilars and the potential introduction of biosimilar aflibercept for treating retinal diseases. Experts discuss their preferences for specific drugs and highlight the evolving landscape, anticipating challenges in drug selection and emphasizing the need for collaboration between retinal specialists and insurance companies to optimize patient care.

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