AMD 

Cataract & Refractive

Cornea

Gene Therapy

Glaucoma

Inflammation & Infection

Paediatrics

Retina

Articles

Media

All Videos

Eyeviews

Insights

Medical World News

Podcasts

Rapid Readouts

Viewpoints

Publications

Digital Edition

Supplements And Featured Publications

Conferences

Conference Listing 

CME/CE

Resources

ZEISS Clinical Cases

Zeiss Cataract Insights

Zeiss Cataract Digitalization

Enhancing the Patient Journey

EYLEA 8mg for nAMD and DME Treatment

Between the Lines

Subscribe

Ophthalmology Times Europe connects eye care professionals with surgery, imaging, gene therapy, & diagnostic advances to enhance clinical and patient care.

Advertise

About Us

Editorial Info

Editorial Board

Contact Us

Terms and Conditions

Privacy

Do Not Sell My Personal Information

Ophthalmology Times Europe – Clinical Insights for Eye Specialists

Facebook

LinkedIn

Spotlight

Heidelberg Engineering: Enhancing the Patient Journey

Clinical

1rem

John Kitchens, MD, is joined by Diana Do, MD, to discuss the PHOTON trial results and their relation to patients with diabetic macular oedema (DMO) in clinical practice. They discuss the half-life of aflibercept in wet age-related macular degeneration and its implications for drug durability. They explore the potential for more frequent dosing of aflibercept for DMO, with a focus on safety monitoring and the use of adjuvant steroids. 

See the key takeaways below, and listen to the full podcast for all the clinical pearls.

Considering aflibercept half-life and higher molar dose in ophthalmology.

Highlighting the variability in intraocular half-life of aflibercept, including factors such as patient characteristics and vitreous liquefaction that may have an impact.

Discussing the concept of nonresponders, and whether frequent dosing may indicate a need for more frequent treatment rather than a lack of response to the drug.

Using aflibercept for DMO, with focus on dosing and response variability.

Discussing whether aflibercept 8 mg every 12-16 weeks is noninferior to 2 mg every 8 weeks in DMO patients.

Using the art of medicine to tailor aflibercept dosing based on patient response.

Using higher doses of aflibercept for DMO, with potential for more frequent dosing.

Mixing steroids with aflibercept may help treat recalcitrant DMO.

Using combination therapy shows improved response in DMO treatment.

Discussing safety signals for hypertension, intraocular inflammation, and retinal vasculitis for patients receiving aflibercept 8 mg.

John Kitchens, MD, is joined by Diana Do, MD, to discuss the PHOTON trial results and their relation to patients with diabetic macular oedema in clinical practice.

PHOTON Results and Their Relation to DME Patients in Your Practice

John Kitchens, MD, is joined by David Brown, MD, to discuss the PULSAR study results and their relation to patients with neovascular age-related macular degeneration in clinical practice. They touch upon dosing strategies and also highlight two new drugs, faricimab and aflibercept 8 mg. They also discuss the potential benefits of increased molar dosing and the importance of maintaining dryness and durability in patient care.

Drug dosing and half-life in retina treatment.

Highlighting developments in ocular drug delivery, including new formulations of existing drugs and potential challenges in the clinic.

Discussing increased molar dosing of aflibercept.

Explaining the variability in patient clearance rates and their impact on treatment outcomes.

Aflibercept 8 mg, including study findings and clinical practice applications.

Clinical practice for aflibercept dosing, including loading doses and extension intervals.

Prioritising individualised approach based on patient's response and disease activity.

The safety and efficacy of a drug for treating retinal diseases.

Extending drug treatment from 8 weeks and onward with positive patient response.

Safety data and potential label change with regulatory agencies.

The importance of manufacturing processes and the challenges of creating fully human antibodies to VEGF.

John Kitchens, MD, is joined by David Brown, MD, to discuss the PULSAR study results and their relation to patients with neovascular age-related macular degeneration in clinical practice. 

PULSAR Results and Their Relation to nAMD Patients in Your Practice

Dr Ramtohul's research uses electrophysiologic testing to study the retinal ganglion cells

EURETINA grants Prithvi Ramtohul, MD, 2025 Ramin Tadayoni Award

The US Food and Drug Administration (FDA) also granted RMAT designation for MCO-010 in Stargardt disease (SD). 

EMA grants Orphan designations to MCO-010 across 5 categories of retinal dystrophies

Presentation topics will include therapies for age-related macular degeneration, X-linked retinitis pigmentosa and other retinal pathologies

EURETINA industry previews: Beacon Therapeutics, Nanoscope Therapeutics and Valitor

Clinical leaders including Susan Schneider, MD; Lejla Vajzovic, MD; and Harvey Uy, MD, will share new clinical findings

Ashvattha Therapeutics, Clearside Biomedical, ZEISS preview EURETINA presentations

An understanding of GA growth kinetics is key to addressing the pathophysiology of age-related macular degeneration

Progression rates vary in subtypes of geographic atrophy lesions

EURETINA 2025: Boris Stanzel, MD, methotrexate is rocking the European retina landscape

At this year's meeting of the European Society of Retina Specialists (EURETINA), Boris Stanzel, MD, presented results from two recent studies. Prof Stanzel is an attending physician at the Macula Centre, Knappschaft Eye Hospital Sulzbach, and a professor of ophthalmology at the University of Bonn, both in Germany. In a free paper presented on Saturday, 6 September, Prof. Stanzel discussed the use of intravitreal methotrexate in the preventing and treating proliferative vitreoretinopathy (PVR). In the speaker's corner that same day, he discussed new microperimetry findings and visual outcomes following implantation of an extended macular vision IOL for age-related macular degeneration (AMD).

Intravitreal methotrexate for PVR prophylaxis and treatment: Sulzbach pilot case series experience

"My world, in the moment, is rocked by methotrexate used intravitreally as an adjunct to PVR retinal detachment surgery," Prof Stanzel said. "We are presenting here at EURETINA...the first large European series. We have, right now, 20 patients in our readout who have at least 2 months follow-up to 3 years follow up." The outcomes were very successful, he noted. "Only one patient in this cohort of 22 eyes had a re-detachment, which was recognised at the point of oil removal and was therefore taken care of," Prof Stanzel said. "Methrotextrate is really an agent that makes a difference." The study findings also showed improved outcomes compared to studies in the US, which presented "only modest improvements in vision," he said, but the European studies have an improvement of four lines of vision.

Extended macular vision IOL in macular atrophy: visual and microperimetry outcomes

Prof Stanzel also presented follow-up research findings on hyperaspheric IOL implantation in patients with macular atrophy secondary to AMD. The EyeMax Mono (Sharpview Ophthalmology Ltd.) was implanted in 21 eyes with small areas of geographic atrophy. "This is essentially a follow-up study report from last year. To a large extent, we have maintained the data that we have seen. There is a signficant benefit in patients who have an extrafoveal fixation, whereas the fixation area seems to predict the response in these patients, in terms of visual improvement." Watch the full video to hear Prof Stanzel explain why visual acuity is not necessarily the best marker to guide decisions for patients with geographic atrophy.

Videos

Prof Stanzel detailed new advancements in proliferative vitreoretinopathy and a hyperaspheric IOL designed for patients with age-related macular degeneration

EURETINA 2025: Boris Stanzel, MD, says methotrexate is rocking the European retina landscape

Marion Munk Euretina 2025

Marion Munk, a medical retina and uveitis specialist from Switzerland, introduced the International Retinal Imaging Society (IntRIS), a unique organization that brought together retina specialists, ophthalmologists, PhDs, and biomedical engineers. The society was dedicated to advancing retinal imaging through collaborative efforts. 

Munk highlighted the IntRIS symposium at the 2025 EURETINA annual meeting, which is taking place in Paris, France. The symposium featured several distinguished speakers who presented groundbreaking research. Giovanni Staurenghi discussed color autofluorescence. Phil Rosenfeld explored the impact of ocular perfusion on geographic atrophy progression. Srinivas Sadda presented on metabolic activity in RPE cells using adaptive optics fluorescein lifetime imaging. The symposium also included an overview of recommendation guidelines for fibrosis, focusing on development, quantification, and appropriate imaging modalities. 

Munk emphasized the society's unique approach, which brought together diverse specialists to provide comprehensive perspectives on medical challenges. A key strength of IntRIS was its collaborative model. Biomedical engineers worked closely with physicians to develop clinically relevant imaging technologies. This approach ensured that new devices addressed real-world medical needs and had potential market viability. The interdisciplinary nature of the group allowed for innovative thinking and novel approaches to understanding retinal diseases. 

Munk stressed the importance of ultra-widefield imaging and its potential to transform clinical decision-making. She noted that imaging technologies must go hand-in-hand with drug development, providing robust methods to quantify and visualize conditions like non-perfusion and fibrosis. The conversation highlighted the challenges in current imaging technologies, particularly in differentiating between various types of retinal tissue. Munk argued that as drug therapies advance, more sophisticated imaging techniques would become crucial for precise diagnosis and treatment monitoring. The IntRIS symposium represented a forward-thinking approach to retinal imaging, combining clinical expertise, technological innovation, and collaborative research to push the boundaries of medical understanding and treatment.

Discover how the International Retinal Imaging Society fosters collaboration among specialists to advance retinal imaging and transform clinical practices.

Canonical

EURETINA 2025: Marion Munk, MD, PhD, discusses the IntRIS symposium

EURETINA 2025: Aleksandra Rachitskaya and Danilo Ianetta on the Vit-Buckle Symposium

The Vit-Buckle Symposium will be a part of the EURETINA annual meeting in Paris, France, again this year. To discuss this symposium, Aleksandra Rachitskaya, MD, FASRS, from Cleveland Clinic Cole Eye Institute, and Danilo Iannetta, MD, PhD, from Rome Sapienza University, spoke with the Eye Care Network. 

The symposium was designed to showcase challenging surgical cases from presenters worldwide, with a significant portion dedicated to open and honest discussions. Participants believed that learning was most effective when sharing complex medical scenarios rather than just highlighting successes. Iannetta described the session as highly dynamic and interactive, structured around 2-minute surgical video presentations followed by extensive discussions. The format encouraged surgeons to learn from each other's experiences and perspectives. 

The Vit-Buckle Society distinguished itself by welcoming members at all training levels, including medical students, residents, and fellows. Members gained access to extensive educational resources, including webinars in surgical and medical retina, and opportunities to participate in international meetings. 

Iannetta shared his long-standing connection with the society, having first engaged with it in 2014 during a year-long stay in New York. He observed the organization's consistent growth and commitment to creating a multicultural, international scientific community. 

The society will host its annual meeting from April 9-11, 2026, in Las Vegas, Nevada, USA, and is inviting abstracts from participants worldwide. The members emphasized their commitment to supporting young professionals, offering free membership for trainees and opportunities for international participants to present their work. 

Key highlights included the society's presence at multiple international conferences, including recent appearances at the Pan-American meeting and an upcoming event in Asia. Both Rachitskaya and Iannetta stressed the importance of collaboration, knowledge sharing, and supporting emerging medical professionals. The symposium represented more than just a medical conference; it was a platform for global medical professionals to connect, learn, and grow together. By creating an inclusive, interactive environment, the Vit-Buckle Society aimed to advance medical knowledge and support the next generation of eye care specialists.

The Vit-Buckle Symposium fosters global collaboration among eye care professionals, emphasizing interactive learning through challenging surgical case discussions.

EURETINA 2025: Aleksandra Rachitskaya and Danilo Iannetta on the Vit-Buckle Symposium

Anat Loewenstein, MD, speaks about the record-breaking number of attendees at EURETINA 2025

The European Society of Retina Specialists (EURETINA) welcomed over 10,000 international attendees to its 25th annual congress, held this year in Paris, France. EURETINA President Anat Loewenstein, MD, sat down with the Eye Care Network to share details of the meeting, held September 4 through 7 at Le Palais des Congrès.

The 2025 Congress is the largest one yet. Prof Loewenstein noted a 25% increase in abstract submissions. "The review process was very, very strict," she said. "Each paper had at least three reviewers. This really reflects the ongoing, amazing research that is going on in the field of retina. We increased the number of free papers this year, as much as the venue could accommodate. We really want to hear what people have to say."

Watch the full interview to learn more about this year's research findings that will be presented at the congress, including the data Prof Loewenstein will be sharing in clinical sessions.

This year's EURETINA meeting boasts a crowd of 10,000 attendees, including delegates, industry leaders, and young retina specialists.

EURETINA leadership welcome record-breaking number of attendees

João Pedro Marques, MD, MSc, PhD discusses a retrospective study of 800 patients with inherited retinal diseases 

Gene therapies were a popular part of the programme during the American Society of Retina Specialists (ASRS) annual meeting. But even as clinicians understand more about genetics and inherited conditions, unsolved mysteries prevent patients from receiving vision-saving care.

At this year's ASRS meeting in Long Beach, California, the Eye Care Network spoke with João Pedro Marques, MD, MSc, PhD, about his presentation. He is affiliated with Centro Hospitalar e Universitário de Coimbra in Coimbra, Portugal. Prof Marques spoke about inherited retinal diseases (IRD) and common challenges in genetic testing. He explained that genetic testing can be a pain point for clinicians and patients, and obstacles to accurate testing can have a major impact on the care patients receive.

"Even if you use state-of-the-art genetic testing, up to 30% of patients will remain genetically unsolved," he said. These inconclusive outcomes can be highly frustrating, Prof Marques explained. As such, his team conducted a retrospective, single centre study. Its goal was to identify baseline determinants which might predict ifi a patient's IRD can be genetically "solved" and attributed to a specific gene function.

In the study, over 800 patients with IRDs were classified into predetermined phenotypes.

"We found that the age of onset [being] before 18 years of age, the presence of familial consanguinity and the presence of a family history are actually significant determinants to obtain a positive genetic testing result," Prof Marques recounted. "If you put these factors all together, the likelihood of obtaining a positive test is even higher. However, if none of these factors are present, you'll get only a 30% chance of having a positive genetic testing result."

"Our main highlight is actually how real-world data can impact your daily clinical practice," he continued. "This is very important because of access to clinical trials and access to new gene therapies. If you don't have a genetic diagnosis, you won't be able to be enrolled in these kinds of treatments."

Watch the video to hear the complete findings in this new IRD research.

Helping patients navigate the unsolved mysteries of genetic testing

Christine Curcio, PhD, shares histology update and revised nomenclature for OCT

Christine A. Curcio, PhD, spoke to the Eye Care Network about her presentation at the 2025 International SPECTRALIS Symposium – And Beyond (ISS). At this year's ISS meeting, held on 13 and 14 June in Heidelberg, Germany, Prof Curcio spoke on histology and optical coherence tomography (OCT) interpretation. She recounted details of that lecture in the above video.

Curcio is the emerita professor of ophthalmology and visual sciences at the University of Alabama at Birmingham Heersink School of Medicine, in Birmingham, Alabama. Prof Curcio and her team use volume electron microscopy to correlate high-resolution tissue data with OCT B-scans. New techniques in histology are refining the way clinicians use software tools, and the OCT nomenclature used to describe findings, Prof Curcio said.

“We built on the success of the 2014 international OCT consensus by Staurenghi et al,” Curcio said. She refers here to a landmark framework, developed by clinicians in Italy, the United Kingdom, California and New York, published in 

 The consensus introduced terms, such as ellipsoid zone and interdigitation zone, which are a key aspect of retinal research today. A detailed and accurate imaging framework is crucial to understanding retinal disease, she noted. “Attention to precision is really essential,” she said.

Staurenghi G, Sadda S, Chakravarthy U, Spaide RF; International Nomenclature for Optical Coherence Tomography (IN•OCT) Panel. Proposed lexicon for anatomic landmarks in normal posterior segment spectral-domain optical coherence tomography: the IN•OCT consensus. 

. 2014;121(8):1572-1578. doi:10.1016/j.ophtha.2014.02.023

Christine A. Curcio, PhD, shares an update on histology and its critical role in advancing <3 μm optical coherence tomography interpretation 

Refining what clinicians see and treat in outer retinal disease with Christine Curcio, PhD

SriniVas R. Sadda, MD, FARVO, shares key points from his retina presentation at the International SPECTRALIS Symposium

At the International SPECTRALIS Symposium – and Beyond (ISS) in Heidelberg, Germany, a lineup of imaging experts shared their thoughts on the ever-changing field. SriniVas R. Sadda, MD, FARVO, presented a lecture on high-resolution optical coherence tomography (OCT). At the ISS, he said high-resolution OCT shows diagnostic and prognostic promise for atrophic and precursor lesions in age-related macular degeneration (AMD).

Biomarker-based risk stratification is a strategy Dr Sadda already uses in his clinical practice, he said. “We’ve spent a lot of years trying to establish the pathway to the development of atrophy in AMD,” he said. "These biomarkers are very important to recognise."

High-resolution OCT has a stronger axial resolution than standard-resolution OCT, giving structural features of the eye a distinct appearance. This allows clinicians to distinguish true hyperreflective foci from retinal vasculature, for example. Additionally, clinicians can differentiate incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA) from complete RPE and outer retinal atrophy (cRORA), a vital distinction to make in treating patients with AMD.

Watch the full video to hear how the nuanced monitoring made possible by high-resolution OCT can help diagnose and treat patients.

High-resolution optical coherence tomography illuminates crucial biomarkers in age-related macular degeneration, Dr Sadda said

Robert Sergott, MD, describes fluorescence lifetime imaging ophthalmoscopy (FLIO) and the International SPECTRALIS Symposium – And Beyond (ISS) in Heidelberg, Germany.

Robert C. Sergott, MD, of Wills Eye Hospital, presented during the New Technology session at the International SPECTRALIS Symposium (ISS), 13-14 June, in Heidelberg, Germany.

During his lecture, Dr Sergott discussed fluorescence lifetime imaging ophthalmoscopy (FLIO), an emerging imaging modality for ophthalmic and neurologic pathologies. He highlighted the potential FLIO demonstrates in diagnostics and therapeutic monitoring for retinal disease and neurodegeneration.

According to Dr Sergott, FLIO's relationship to optical coherence tomography (OCT) mirrors that association between positron emission tomography (PET) was to magnetic resonance imaging (MRI). In other words, FLIO is ushering clinicians from structural imaging toward functional imaging. Dr Sergott is the Margaret and Richard Hayne Distinguished Director at the Annesley EyeBrain Center at Jefferson University, partnered with Wills Eye Hospital. There, he and his colleagues are focused on using FLIO to distinguish patterns of mitochondrial dysfunction and protein misfolding which can be biomarkers of neurodegenerative diseases including multiple sclerosis, Alzheimer andParkinson disease.

Watch the full video to hear more about the promise of FLIO, including the possibility of personalised disease modeling, drug testing and more.

FLIO ushers clinicians from structural to functional imaging, said Robert Sergott, MD, in a presentation at the International SPECTRALIS Symposium

Fluorescence lifetime imaging ophthalmoscopy (FLIO) reveals the brain's best-kept secrets

Anat Loewenstein, MD, describes her presentation on remote imaging for age-related macular degeneration and geographic atrophy at the International SPECTRALIS Symposium, in conversation with Hattie Hayes of Ophthalmology Times Europe

Anat Loewenstein, MD, co-chaired the retina session and presented in the distributed care session at this year’s International SPECTRALIS Symposium (ISS). She is the director of the division of ophthalmology at Tel Aviv Medical Center in Israel.

Prof Loewenstein commented on trends in the contemporary imaging landscape, a key segment of her ISS presentation on home monitoring. “Something that comes up loud and clear is we need to find ways to correlate between function and morphology,” Prof Loewenstein said. “Everyone looks for imaging that will show biomarkers that are predictive of progression.”

Prof Loewenstein said that, along with optical coherence tomography (OCT), advanced technologies like OCT angiography (OCT-A) and fluorescence lifetime imaging ophthalmoscopy (FLIO) are quickly changing what is possible in diagnostics. That's good news for patients with age-related macular degeneration, geographic atrophy and other retinal pathologies. However, she warned that technology alone is not enough to improve and preserve patients’ health outcomes.

“You cannot use remote monitoring as a standalone [tool.] Everyone wants to use AI and remote monitoring, but you need to coordinate with your health system,” she advised. “[Remote monitoring] needs to be supported by the community of retina physicians and of ophthalmologists, so the healthcare system and the payers will be in agreement with the need to use it in our system.”

Watch the video to hear Prof Loewenstein’s full interview and learn about her presentation at the ISS in Heidelberg, Germany.

Anat Loewenstein, MD, presented real-world results of remote imaging at the International SPECTRALIS Symposium


Modern monitoring strategies remove major barriers to retina care

Tyson Brunstetter, OD, PhD, shares key takeaways from his keynote at the International SPECTRALIS Symposium

Heidelberg Engineering holds its 21st International SPECTRALIS Symposium (ISS) in its eponymous hometown of Heidelberg, Germany, on 13 and 14 June, 2025. The first ISS held in the newly-opened Heidelberg Congress Center will include a keynote address by two scientists from the US-based National Aeronautics and Space Administration (NASA).

Tyson J. Brunstetter, MBA, OD, PhD, FAAO, FAsMA, is a US Navy aerospace optometrist at the NASA Johnson Space Center in Houston, Texas. He is the clinical lead for NASA’s research into spaceflight-associated neuro-ocular syndrome (SANS), a condition which is common among astronauts, especially during long-duration missions.

Dr Brunstetter discussed the keynote address. He delivered the keynote in conjunction with Warren “Woody” Hoburg, who is part of the NASA astronaut class of 2017 and logged a total of 186 days in space on his first flight.

Dr Brunstetter provided deep background on SANS and its distinctions from other neuro-ophthalmic pathologies. Additionally, he encouraged audiences to think outside the box—or, when necessary, outside gravity—in their own day-to-day lives.

Dr Brunstetter, a US Navy Aerospace Optometrist at the NASA Johnson Space Center in Houston, Texas, delivered the lecture at this year's ISS alongside his colleague Warren Hoburg

 I think the port delivery system [PDS] can have a very significant clinical impact on the treatment of wet AMD [age-related macular degeneration]. We’re all aware of the treatment burden patients have with frequent intravitreal injections. In addition, we know the peaks and troughs of anti-VEGF injections can affect the recurrence of wet AMD. Given that it is a continuous delivery of anti-VEGF therapy, not only can this potentially reduce the treatment burden for patients, there is also a possibility for disease modification with the port delivery system.

The fact that many patients in the LADDER study did not even meet refill criteria, and that 98% of patients in the ARCHWAY trial did not need any additional treatment before the first refill, implies that we may be actually modifying the disease to the point of even potential quiescence for some of these patients.

Now that we have the port delivery system as an approved option, it’s important to consider how it can fit into our treatment plan. I have plenty of patients who require monthly or Q2 monthly [every 2 months] intravitreal injections. I think these are the patients I will first have a discussion with, and talk to them if they’re interested in potentially having a longer-term delivery of intravitreal anti-VEGF. Reducing the treatment burden will be very appealing for many of these patients. Of course, the risk and benefits of surgery need to be weighed carefully for such patients. One of the factors that I consider for PDS is the frequency of injections that the patients have. I also will look at the stability for these patients. If these patients can be stable on a monthly or every 2 months setting, we may still discuss it. However, if they’re having recurrent fluid, I think I’ll be much more likely to discuss the port delivery system. If a patient happens to be very stable with injections only every 3 or 4 months, the port delivery system may not be as appealing for some of these patients, unless they’re against getting transscleral intravitreal injections. With respect to insurance approval, of course many of these questions are yet be answered. However, we certainly hope and anticipate for insurance to cover this procedure. It is yet to be determined if it will be a step-wise approach, but I surely hope these critical patient-care decisions are left up to the physician, with explanation and discussion with the patient, and not mandated policy.

Having performed many of these surgeries already during the clinical trials, I can say that the patients who have received the port delivery system are quite happy. They do notice a stability of their disease. In addition, with the refill procedure, although technically it is very different from an intravitreal injection, and the surgeon has to be very aware of the different techniques, for the patient experience, it’s quite nice. It’s more tolerable because there’s no transscleral penetration of a needle. Patients often report that this was a much more comfortable and easier process to do. In terms of the implantation, it’s also considered to be quite painless. Most patients may have a little bit of itchiness or mild irritation immediately in the first 1 to 2 days of the postoperative period. Otherwise, it is a very well-tolerated procedure, and patients seem to have a very good experience.

With the approval of the port delivery system for neovascular AMD, I think the future for this platform is quite interesting; it has a lot of great potential. Studies are underway for both diabetic macular edema, as well as diabetic retinopathy. In addition, as we develop better compounds that may be more efficacious, such as bispecific molecules, marrying the PDS platform with these new molecules may yield even better results for our patients. I think there are a lot of exciting possibilities for the PDS platform.

As our retina specialty embarks upon a new era for the treatment of wet macular degeneration, I think as colleagues, it’s important that we utilize all the resources available. I highly encourage you to use all of the information, as well as surgical device liaisons, for example, in order to help maximize our patient outcomes.

Closing out his discussion on the port delivery system in retinal diseases, Chirag Jhaveri, MD, considers how this approach has impacted the treatment landscape. 

Clinical Implications of Port Delivery System in Retinal Diseases

As we all start performing more of these surgeries, since it is now approved for the use of neovascular AMD [age-related macular degeneration], it is going to be very important to review videos prior to implantation of the PDS [port delivery system] in our patients. In addition, there are surgical simulators that can give you great hands-on experience. I anticipate many of these simulators to be available at many of our meetings, including ASRS [the American Society of Retina Specialists] and AAO [American Academy of Ophthalmology]. It’s also very important to have a good relationship with your surgical device liaison. These individuals are going to be very helpful in guiding you through your first few surgeries. They will be present as needed in your operating room, and they will definitely be there for your first few cases. I highly recommend utilizing them, as they’re wonderful resources to help guide you through your first few cases.

The surgical device liaisons are individuals who you can get in touch with through the company representatives. They are individuals who are there for your resource, and to help guide you in learning any of the tips, pearls, and steps that you would like to discuss for the PDS implantation.

A detailed description of both the implantation and the refill is going through publication approval. These will also have associated videos. In addition, if you would like more videos, you can also discuss this with your surgical device liaison, and they’re happy to provide additional teaching techniques and videos.

Concise insight on education and training strategies that will optimize use of the port delivery system in retinal diseases.

PDS in Retinal Diseases: Practical Advice on Education and Training 

The LADDER trial was a phase 2 trial that showed overall good safety and efficacy for the port delivery system [PDS] for the treatment of neovascular AMD [age-related macular degeneration]. It looked at varying doses of ranibizumab in the PDS implant. Patients were dosed at 10-mg, 40-mg, and 100-mg concentrations. Interestingly, and this is different than the ARCHWAY study which we’ll talk about shortly, patients were only given a refill of ranibizumab if they met criteria of worsening fluid, vision, or new submacular hemorrhage. The 100-mg concentration, which is what is approved, showed that about 80% of patients were able to go 6 months or longer before needing a refill; the median time for needing the first refill in the 100-mg group was nearly 16 months.

Overall, the port delivery system procedure was very well tolerated. As mentioned before, after the modification of the technique, patients did not have any vitreous hemorrhage within the first month. The refill procedure was also very well tolerated, and was able to be done in an in-office setting.

Coming from very good results from the LADDER trial, ARCHWAY was the phase 3 trial, which was a 2-year study comparing monthly ranibizumab to the PDS implant with 100 mg ranibizumab and refills [every] 6 months. The patients enrolled in this study were patients who had wet AMD, were diagnosed within 9 months of screening, and who were responding to anti-VEGF treatment. The ARCHWAY trial showed that 98% of patients were able to go without any additional treatment in the PDS group. The PORTAL trial is an extension study that will be looking at how patients do beyond 2 years. The safety and tolerability of the procedure were also consistent with the LADDER study, particularly with respect to very low incidence of vitreous hemorrhage, as well as the procedure being very well tolerated.

The patients who were included in the ARCHWAY study were recently diagnosed with neovascular AMD. All the patients had to be diagnosed within 9 months of their screening visit, and they all had to show a good response to anti-VEGF therapy.

The ARCHWAY study so far shows that patients are tolerating the port delivery system very well, even in a long-term manner. We’re also showing that patients have good, consistent visual recovery, as well as good stability of their macular thickness. We also analyzed patients with fluid fluctuations, and showed that patients with the port delivery system have good minimization of fluid fluctuations, similar to having monthly ranibizumab injections. I’m also excited about learning what longer-term data are going to show in the PORTAL study. The PORTAL study is looking at patients well beyond 2 years, as well as multiple refills beyond 2 years.

Chirag Jhaveri, MD, reviews the trial design and results of the LADDER and ARCHWAY studies, which tested the port delivery system in neovascular AMD. 

PDS in Retinal Diseases: Interpreting the LADDER and ARCHWAY Studies

The port delivery system is an ocular delivery system that is surgically inserted via the pars plana area in the superotemporal quadrant of the eye. It provides continuous delivery of ranibizumab to the posterior segment. It has a reservoir chamber where a higher concentration of ranibizumab is held, and there is slow release into the vitreous cavity. It has been approved for use in patients with neovascular AMD [age-related macular degeneration], although other indications, including diabetic macular edema, are also being investigated.

With the approval of Lucentis [ranibizumab] for the indications of neovascular AMD, the treatments for neovascular AMD were revolutionized. However, there still is a significant treatment burden for many of our patients who require frequent, often monthly, injections. The treatment burden for both the patients and the family can be quite high. In addition, although we’re delivering a nice bolus of anti-VEGF treatment, there is a waning of the amount of medication in the vitreous cavity. Therefore, a more sustained, endurable treatment modality was needed. Like most devices, the port delivery system was started in the preclinical stages, where it was developed and then tested in nonhuman subjects. Once its safety was verified, it went on to trials to verify safety in human patients, and then to look at the efficacy.

In the phase 2 LADDER study, the technique that was done in human patients initially showed an increased risk for vitreous hemorrhages. The technique for implantation was modified to include laser cautery of the corneal bed]. After this, the incidence of vitreous hemorrhages dropped precipitously. Prior to the amendment, there were 6 out of 10 cases of vitreous hemorrhage. After the amendment, there were no cases of vitreous hemorrhage out of 48 patients within the first month, which is generally considered the postoperative period. At 2 months, there was 1 patient who did have a vitreous hemorrhage.

Although the procedure is generally well tolerated, since it is surgical procedure, there are some potential complications that surgeons and patients should be aware of. Initially, in the LADDER study, there was a higher rate of vitreous hemorrhages. A modification of the procedure has since reduced those rates tremendously. Any surgery has a risk of infection, and with respect to the implant itself, if the conjunctiva is not closed properly or not covering the implant adequately, there is a possibility of the implant being exposed. Also, if the conjunctiva is very thin, there is a possibility of erosion. Therefore, presurgical evaluation and meticulous care to close the conjunctiva are very important.

When evaluating a patient preoperatively, you want to take note of a few things. Particularly, you want to take note of the conjunctiva to see if it’s very thin, and if there’s good mobility of the conjunctiva, so that you can adequately access the subconjunctival and sub-Tenon space. In addition, you also want to note any areas of potential scleral thinning, so that when you’re making your wound you’re aware, and so you don’t start making your wound too deep. In addition, you may also want to avoid those areas, so that there isn’t a risk of dehiscence or any other potential issues with the wound.

Expert insight on the history of the port delivery system in neovascular AMD and how it has impacted patient experience and outcomes.

The Development and Safety of Port Delivery System in Retinal Diseases 

: Before we conclude, I would like to get some final thoughts from all of you. Let’s start with Dr Korobelnik. Can you say a few words on the future of dry AMD [age-related macular degeneration]?

 We have seen a lot of research activities for new long-duration treatments in wet AMD and in diabetic retinopathy. There is also a lot of research and developments for advanced dry AMD, for geographic atrophy, and there are currently 2 ongoing phase 3 trials from 2 companies that are looking at inhibition of the complement cascade. We should know later in 2021, or in 2022, [whether] those drugs are beneficial to slow down the progression of the disease. If it works, this will be interesting because it’s a completely unmet need [right now]. We’ll see.

 Thank you. So it’s all about inflammation at this time?

 Dr Moosajee, do you have some concluding remarks?

Mariya Moosajee, MBBS, BSc, PhD, FRCOphth:

 I am truly excited by my field. For the first time in our careers, we can now say that there is an approved gene therapy available for patients with inherited retinal disorders, with a wealth of trials to follow up. I would like to see more genes being covered, and that, at the moment, is still a very costly process, so maybe it’s targeting more common pathways. There are gene therapies that are being developed towards a factor called rod-derived cone viability factor, which essentially helps cones to uptake glucose and to convert that into energy and work better. Hopefully that kind of universal treatment will be able to be accessed by more patients with inherited retinal disorders rather than on a gene-based system. It is a promising field and we will learn a lot from the work that is being done in AMD and diabetic retinopathy, in terms of the devices that you’re using and trialing now, and how we can apply that to our field.

 Thank you. Dr Peto, some words from your side?

 I completely agree that we live in an exciting era of diagnostics and treatment. Something we’ve learned from the pandemic is that patients adapt very well to the new environment. We are now seeing patients over the age of 90 who will happily have a virtual consultation with us. We are seeing people who are using home monitoring devices, and we’re also seeing patients who happily come to virtual clinics where they spend very little time, get images quickly, and then only come back to a busy clinic if they need injections or treatment. We need to learn from these developments, we need to cherish them and go on with providing the best service because this helps us to strategize and restratify our clinics and get everyone to the right clinical pathway.

 Do you think this digital world will reduce the quality? Five years ago we all spoke about multimodal imaging, high-quality images, and combining images from different modalities, just to be more secure and do more sophisticated diagnostics. Now everything is digital. We do images with devices at home, which don’t have the quality as compared with devices in a big hospital, and you can’t combine different images. Do you think the quality will go down a little bit?

 What we need to do is to make sure that the quality of those images that we get supplied with go up. When they started the anti-VEGF [vascular endothelial growth factor] injections, we didn’t have SD OCTs [spectral domain optical coherence tomography], we had time domain OCTs. As soon as more people used them, more people needed to have an OCT, and more people needed more details—suddenly the price dropped, and a lot of new functions appeared. I’m hoping that the home monitoring devices will undergo the same type of development. We must remember that, in a lot of patients, we only need to decide if they need to come in or not, and if they need an injection or not. So we might not need every single time and every bit of imaging that we usually do at diagnosis. If we’re clever about it and we get good images, then we might be able to change the dynamic of a clinic to those who are higher risk.

 We must differentiate between initial visit baseline to make the diagnosis, then we need multimodality and follow-up. For follow-up, OCT probably does it all. So home monitoring with OCT can be promising. We don’t need multimodality on each visit.

Key takeaways from a discussion on the management of age-related macular degeneration, diabetic macular edema, and inherited retinal disease and insight regarding what to look forward to as the field advances.

Retina

Latest News