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22 SEP 2018 PIE Ma ga zine’s D aily C ong re s s New s on the P o s t e rio r S e gment

HIGHLIGHTS Experts from Brazil pg04 present developing world issues affecting the eye

A symphony of surgical instrument innovation...check it out...

With Artificial Intelligence, the patients win!

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etinal specialists, now more than ever, have access to a wide range of new technologies which are revolutionizing the field, renowned specialists said yesterday at the 18th EURETINA Congress. One of the EURETINA 2018’s main sessions yesterday on novelties and late breaking developments in retina and technology discussed several of the latest cutting edge technologies – from artificial Intelligence (AI) to stem cell therapies, and heads-up surgery. “Heads-up surgery will improve in the future and probably replace conventional surgery,”said Professor Jose Garcia Arumi, of Universidad Autónoma Barcelona, Spain, who spoke on the recent advances and surgical techniques, including new trends and expectations. Surgeons today can look at a display through a microscope using a 3D device such as a screen or goggles, instead of using microscopes. These hightech 3D visualization systems are an advantage as surgeons no longer need to sacrifice their posture, because the technology allows for surgeons to look up at large organic light-emitting diode (OLED) screens. Some 97.1% of volunteers in a comparative study said they preferred the ergonomics of heads-

up technology compared to 85% of retina surgeons who complain of neck and back pain when hunching over conventional scopes. The heads-up systems have been developed for more than 10 years for anterior segment surgery as well as other surgical fields such as neurosurgery and abdominal surgery. In 2010, they were introduced in the field of vitreoretinal surgery. Cont. on Page 5 >>

HOTSHOT

Will the real Mozart please stand up? He did, and continued to talk melodiously about ophthalmic revolution, Page 13, during our PIE Talks video filming on location.

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////////Science for a better life

21 September 2018 | Vienna, Austria

Will old age stop us seeing our grandkids? 80 80 %

of visually impaired % people are over the age of 50

of all visual impairment can be prevented or cured

CanWeLiveBetter.com Source 1: GBVI â&#x20AC;&#x201C; Global Disaggregation of Numbers for Gender and Age. IAPB Vision Atlas, 2017 Source 2: Vision Impairment and Blindness. World Health Organization, 2017 L.AT.MKT.09.2018.8551 September 2018

PIE Magazine’s Daily Congress News on the

Posterior Segment

Real World Clinical Data on Aflibercept Provides Lessons on Improving Patient Care by Hazlin Hassan

he anti-vascular endothelial growth factor (anti-VEGF) agent aflibercept (EYLEA, Bayer), has recently been approved in Europe and elsewhere for use with a proactive treat-and-extend regimen starting in the first year of treatment in neovascular age-related macular degeneration (nAMD), delegates attending the Bayer Satellite Symposium at the 18th EURETINA Congress heard yesterday. “The new posology for aflibercept in nAMD reflects its suitability for a proactive treat-and-extend regimen,” said Professor Jean-Francois Korobelnik, of the University Hospital Centre, Bordeaux, France. This allows extension of treatment intervals in 2- or 4-weekly increments in Year 1 at the discretion of the physician. A total of 57% of patients in the Phase IV ALTAIR study in Japan had their next injection scheduled at an interval of 12 weeks or beyond at the Week 52 mandatory visit, he added. Treat-and-extend means to initiate treatment with loading doses until the disease is stable. The doctor then gradually extends the treatment time between treatments until sub-retinal fluid recurs or visual acuity declines. The symposium also showcased the evolution of Real World Evidence (RWE) within retinal ophthalmology. It is no longer enough to carry out controlled trials. RWE is now increasingly important to provide effective treatments for the patients’ diverse needs. Hospitals are now moving from paper records into the era of “big data” using electronic medical records (EMRs), greatly benefiting both specialists and patients, Professor Adnan Tufail, consultant ophthalmologist at Moorfields Eye Hospital, United Kingdom, told the audience. EMRs are akin to an electronic case report form in a clinical trial but obtained as part of routine clinical care. Big data in ophthalmology included EMR, imaging data, and genetics data, said Prof. Tufail, whose spoke mainly on RWE and the evolution of a key information source. He said his first attempt at conducting a

Panelists, Bayer Satellite Symposium, ESCRS 2018

study using EMRs was in 2012, where 16 hospitals were approached and within two months, 11,135 patients were signed up with 92,976 injections administered, in patients who were as old as 108 years of age. Showing a graph of subgroups of mean visual acuity, he demonstrated that there is huge variability among patients. RWE can also go beyond outcomes of a single disorder and can be used to look at interaction between interventions, he said. “When you’re looking at big data, you need to actually look at the quality of how you measure information as well” he said. “In summary, there is a wealth of real world data out there, we initially used it to benchmark outcomes, but we are now moving into health economics and personalized medicine using data, and looking at novel ways to help us understand it,” he concluded. “Historically, there has been a disparity between results observed in randomized controlled trials (RCTs) and real-world studies of ranibizumab,” said Dr Peter Kaiser, of the vitreoretinal faculty of the Cole Eye Institute at Cleveland Clinic in Ohio, United States. His lecture on aflibercept’s latest evidence from clinical practice discussed the reasons for the disparity, citing differences in baseline characteristics, and disease progression, poor understanding and application of the treatment outcomes, irregular or no auditing and/or benchmarking of the treatment outcomes, and a high visit and/or treatment burden on patients and caregivers. He suggested that in real-world clinical practice, maintaining a sufficient frequency of injections may be critical for achieving good visual acuity outcomes. “Good visual

outcomes were achieved in some countries where strict monitoring and retreatment criteria were followed. However, poor outcomes were reported in many countries, particularly where PRN (pro re nata or as needed) regimens are typically used in clinics.” On aflibercept, he said that its dual mechanism of action and strong binding affinity made it suitable for proactive extended dosing. “Aflibercept is known to bind VEGF-A with a higher affinity than its native receptors, ranibizumab, or bevacizumab,” he said. In individual patients with nAMD, aflibercept was shown to have an intraocular VEGF-A suppression time of around twice that of ranibizumab. Citing an ongoing 4-year study known as RAINBOW, which assesses real-world outcomes with aflibercept to treat nAMD in routine clinical practice across 55 centers in France, he said that treatment-naive patients receiving proactive q8 aflibercept achieved significantly greater visual acuity gains at Month 12 than those receiving irregular dosing. Similarly, another ongoing 2-year study called PERSEUS across 66 centers in Germany, also saw the same result, he said. “Further real-world studies are providing evidence to support the comparative effectiveness of proactive dosing with aflibercept.” Bayer is currently funding multiple studies assessing the real-world effectiveness and safety of aflibercept in more than 20,000 patients. Professor Paul Mitchell, professor of clinical ophthalmology and eye health at the University of Sydney Westmead Clinical School in Australia, was also present and took part during the panel discussion.

Prof. Adnan Tufail

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22 September 2018 | Vienna, Austria

Brazilian Ophthalmologists

Highlight Developing World Issues

Affecting Eye Health by John Butcher

iagnosing and treating ocular disease poses particular problems in developing countries, ophthalmologists told delegates at the 18th EURETINA Congress in Vienna, yesterday (September 21). Speaking at a morning session, experts from the Brazilian study group of retinal inflammatory diseases highlighted complications including the prevalence of diseases that can look like ocular problems, in particular syphilis which is a growing issue globally, and diagnosing rare diseases that are specific to certain regions. Diagnosing infectious white dot syndrome is particularly complex in developing countries, according to Dr. Raul Vianna, a professor from the Universidade Federal Fluminense in Brazil.

He presented the case study of a thirty-four-year-old dentist who appeared to have multi-evanescent white dot syndrome (MEWDS). His age, symptoms, clinical picture and ocular complimentary exams suggested MEWDS, but the bilaterality, inflammation and evolution of the disease did not, noted Dr. Vianna, leaving him unconvinced of the original diagnosis. Laboratory results later showed the man had both syphilis and was HIV-positive, which were the cause of the symptoms rather than MEWDS. The result was “not a surprise because I live in a developing country,” where syphilis is a major and growing problem, said Dr. Vianna.

In developing countries it is important to be aware of diseases that look like white dot syndrome, which aside from syphilis include diffuse unilateral subacute neuroretinitis and Cryptococcus neoformans, he added. According to Dr. Vianna, tuberculosis, which is still prevalent in many developing countries, including Brazil, where there are 17,000 new cases a year, can also mimic white dot syndrome syndromes. The similarity in ocular symptoms between white dot syndrome and syphilis is a particular and growing issue, he added, with sexually transmitted diseases on the rise worldwide. He presented a slide showing a dramatic increase in syphilis among pregnant women in Brazil, reaching 24,000 confirmed cases in 2016 according to data from the Brazil Ministry of Health. Dr. Luis Lima, from the department of ophthalmology and visual science at Paulista School of Medicine at the Federal University of Sao Paulo in Brazil, confirmed that ocular problems caused by syphilis – which affects around 11 million adults worldwide, with 90% of cases in developing countries – are increasing. Eye involvement occurs in five to eight percent of syphilis cases, he added, and has been reported at all stages of the disease although this develops more frequently during the secondary and tertiary stages. Ocular manifestations of syphilis include uveitis, interstitial keratitis, iritis, vitritis, chorioretinitis, serous retinal detachment and papillitis. Posterior uveitis is the most frequent complication, and chorioretinitis is the most common posterior segment lesion, he added. Brazilian ophthalmologist Dr. Fernanda Porto spoke about the complications of identifying retinal vasculitis, which she said was usually caused by systemic problems. The disease may behave like syphilis or multiple sclerosis, she said, making it difficult to diagnose. Dr. Vasco Bravo Filho, an ophthalmologist

from Hope Eye Hospital in the Recife region of Brazil, talked about ocular signs of the Zika virus, which is a particularly prevalent in Brazil. The clinical features of Congenital Zika Syndrome include microcephaly and other brain malformations, skeletal abnormalities, hearing problems and ocular findings, shared Dr. Filho. There have been a broad spectrum of ocular findings, he told the audience, including vascular abnormalities, retina issues and optic disc problems. Other common findings include iris coloboma, lens subluxation, glaucoma, cataract and microftalmia. And retinal vascular findings included hemorrhages, vascular attenuation and capillary changes. The combined issues faced by children with Congenital Zika Syndrome means they require therapy for life, ideally from as early an age as possible in order to aid neuroplasticity (the brain’s ability to change) including environmental stimuli. The process of treatment is “worth it” he said, but it is important to begin it from the time of diagnosis. Dr. Maria Frazao, director of the department of ophthalmology at Santa Casa de Sao Paulo, spoke on ocular toxoplasmosis, of which there are high levels in Brazil. Between 25 percent and 30 percent of the global population is infected with Toxoplasma gondii, she said, which is a leading infectious cause of posterior uveitis. In high Toxoplasma gondii areas, ocular toxoplasmosis is the most frequent cause of posterior uveitis, she added, and in Brazil toxoplasmosis is responsible for 43.1 percent of all uveitis and 80 percent of posterior uveitis. She concluded that in countries with endemic toxoplasmosis, such as Brazil, serology, the scientific study or diagnostic examination of blood serum, should be performed systematically in women considering pregnancy, adding that diagnosis should always be double checked.

PIE Magazine’s Daily Congress News on the

Posterior Segment

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Prof. Jose Garcia Arumi

The system also requires lower light intensity, at just 20% to 30 % of the light of conventional microscopy surgery, thereby posing a lower risk of phototoxicity to patients. Such systems are invaluable for education as observers, assistants, fellows and residents are able to see what the surgeon is exactly doing and seeing, and in 3D. Surgeons may also add information onto the screen such as vitrectomy machine parameters and endoscopic images. High image amplification and digital filtration help the surgeon to see better, and highlight ocular structures and tissue layers. However, Prof. Arumi noted some cons to the technology. “While you are working, you are looking to the side, and not to the front, and you may distract yourself by seeing things you don’t need to see. It may also be more difficult for the assistant who have to turn the head in the opposite direction of the visual field.” The screen also has to be placed in the proper position to obtain perfect 3D pictures and to avoid double images. “We believe that artificial intelligencebased analysis of imaging will clearly be one of the major breakthroughs in ophthalmology, particularly in retina,” said Professor Ursula Schmidt-Erfurth, from

the Department of Ophthalmology of the Medical University of Vienna, Austria. Some 90% of treatment decisions are based on imaging, she noted, adding that AI is able to recognize certain anomalies such as intraretinal cysts, subretinal fluid, and disease patterns out of large samples, and at an extremely fast speed, often in seconds. “By using artificial intelligence, we are able to look at all the major diseases that cause fluid-related problems,” she said. “I think that you will all agree with me that it’s impossible for us as human beings [seeing hundreds of patients], to really count cysts but the instrument can do it very nicely.” An AI algorithm is also able to recognize age, gender, smoking status, and so on, which even an experienced doctor will never be able to extract, she added. Furthermore, there are at present many new drugs in the pipeline, including potentially better anti-VEGF treatments (i.e. conbercept, brolucizumab), according to Pravin Dugel, MD, Managing Partner, Retinal Consultants of Arizona, United States. “We are in the midst of an extraordinarily exciting time, there are lots and lots of drugs in development, there are lots and lots of drugs that will change our

We believe that artificial “intelligence-based analysis of imaging will clearly be one of the major breakthroughs in ophthalmology, particularly in retina.

”

- Prof. Ursula Schmidt-Erfurth, Department of Ophthalmology of the Medical University of Vienna, Austria

lives, change our patient’s life, and I can’t imagine being in a better time in retina than now…so very exciting times ahead,” he concluded. On the other hand, Stephane Wolf, Worldwide Head of Digital Solutions, Ophthalmology, Novartis Pharma AG, Basel, Switzerland, introduced the FocalView Apple Research Kit, a freely available app by Novartis. It is designed to modernize ophthalmic clinical trials, making them more accessible and flexible. This is particularly useful for those with limited mobility, he said, noting that the recruitment and retention of elderly patients into clinical trials often prove a significant challenge. “FocalView will allow patients to participate in clinical trials from their own home, potentially overcoming recruitment and drop out issues.” The app contains near vision acuity tests, contrast sensitivity tests, mood tests as well as a daily step count. Cell therapy, while having great potential in ophthalmology to treat untreatable diseases in the retinal field, is a lot like “Dr. Jekyll and Mr. Hyde,” often having two sides to the treatment, both the good and the bad, said Dr. Adiel Barak, Head of Retinal and Vitreous Unit, Tel Aviv Sourasky Medical Center, Israel, who presented about human trials of cell therapy for retinal disease. There have been several cases where commercialization of unproven stem cell therapies, worth an estimated $2.4 billion, and sometimes costing each patient up to $40,000 per treatment, has resulted in vision loss and tumors. He noted however that his center conducted a clinical study of human embryonic stem cells to treat dry AMD (age-related macular degeneration). Following subretinal transplantation there is rapid healing of the injection site, and visual acuity remains stable throughout the study with a follow-up for two years in some subjects. There are also potential early signs indicative of improved retinal structure in the treated areas in several cases, he concluded.

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YAMANE

22 September 2018 | Vienna, Austria

Aflibercept Receives Approval for

Proactive Treat-and-Extend Regimen

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ayer (Leverkusen, Germany) announced the big news during its lunch symposium at the 18th EURETINA Congress on September 21: As of July 20, 2018, aflibercept (EYLEA) has been approved in Europe and elsewhere for use with a proactive treat-and-extend (T&E) regimen starting in the first year of treatment in neovascular age-related macular degeneration (nAMD). This new posology allows for an extension of treatment in twoor four-weekly increments in year one at the discretion of the physician. Currently, a variety of treatment regimens are used in clinical practice for treatment of nAMD. These include the reactive PRN and treat-to-target and the proactive fixed dosing and T&E. During the symposium, Drs. Peter Kaiser (USA), Gemmy Cheung (Singapore) and Paul Mitchell (Australia) discussed aflibercept in terms of a T&E regimen. In T&E, patients are injected at scheduled visits, regardless of visual acuity (VA) or anatomic status – treatment is initiated with loading doses until the disease is stable. Then, from there, treatment intervals are extended until sub-retinal fluid recurs or visual acuity (VA) declines. Multiple studies have shown that aflibercept is effective in a proactive T&E regimen. In the VIEW study, the mean number of injections patients received in year one was 7.5 and in year two, this was reduced to 4.2. Not only was there a reduction in injections, 48% of patients who received aflibercept 2Q8 in year one maintained VA gains in year two, with injection intervals of 12 weeks – and the VIEW 1 extension shows that those vision gains were maintained for more than four years with continued proactive aflibercept treatment.

The PLANET study produced similar results. Patients with PCV received q8 aflibercept and mean injections from year one to two dropped from 8.1 to 4.6, respectively. Plus, they gained >10 letters and maintained VA gains to week 96 with optional T&E. This data shows that good visual outcomes can be achieved with a proactive aflibercept regimen in real-world clinical practice. “Other studies have used this idea of starting q8 week fixed dosing after a loading dose and switching to treat and extend after one year,” said Dr. Kaiser. He notes that in the PLANET study, VA results were great and polyp regression rates were also excellent. “The important thing to note, is that in that second year of the study they switched to treat-and-extend and there was a dramatic reduction in the need for injections while maintaining visual acuity gains – and that’s really what we want for our patients,” he said. The VIEW and PLANET studies are joined by mounting evidence from additional real-world studies of proactive Q8 and T&E aflibercept dosing. “Studies from all over the world are showing similar visual acuity results between the real-world studies and the randomized clinical studies of VIEW and PLANET,” said Dr. Kaiser, Professor of Ophthalmology, Cleveland Clinic College of Medicine, Cleveland, Ohio, USA. “But we’re also seeing real world studies using treat-and-extend, which is something we’re seeing more and more worldwide. And results in these real-world studies, using treat-and-extend is similar again to the to the studies using fixed dosing in terms of VIEW and ALTAIR.”

PIE Magazine’s Daily Congress News on the

In 2016, Epstein et al. published a retrospective study of 85 patients with nAMD who received intravitreal q8 aflibercept to month 12, followed by a proactive T&E regimen to month 18. They found that VA gains achieved with q8 aflibercept in year one (7.7 mean number of injections in months 0-12) were maintained to with proactive T&E to month 18 (2.2 mean injections from months 12-18). Other studies (Eleftheriadou et al. 2018; Hosokawa et al. 2018) found similar results: VA was maintained and the number of injections was reduced. Other than less injections and better visual acuity (VA), this treatment method offers additional benefits to both patients and caregivers. In a 2017 study, Hanemoto et al. found that a proactive T&E regimen was associated with a reduced burden on patients and caregivers compared with PRN, reducing the mean number of visits in one year to 7.9 (T&E) from 14.0 (PRN).

The ALTAIR Study ALTAIR is a Phase IV study designed to evaluate the efficacy of aflibercept with two different T&E dosing regimens in patients with nAMD. The primary objective was to assess the efficacy of aflibercept with two different treatment regimens in nAMD over two years. The secondary objective assessed the safety. This was a multi-center,

randomized open-label study in treatmentnaïve patients with nAMD (≥50 years old; BCVA of 25-73 ETDRS letters [~20/40 to 20/320] in the study eye). All patients received aflibercept treatment (3 x Q4) and were randomized (1:1) at week 16 to either receive a 2-week interval adjustment (n=124) or 4-week (n=123). At week 52 (the primary endpoint) there was a mandatory visit to note changes in best corrected visual acuity (BCVA) from baseline. At week 96, the endpoint was studied. Adjustment of T&E treatment intervals was guided by specific criteria. Intervals were extended if there was no sub-retinal fluid and no loss of ≥5 ETDRS letters, no increase of CRT of ≥100 µm, no new neovascularization and no new macular hemorrhage. Intervals were shortened if new fluid was present, or there was persistent unchanged or increased fluid, along with any of the following: loss of ≥5 ETDRS letters, increase in CRT of ≥100 µm, new neovascularization or new macular hemorrhage. Intervals were maintained if there was residual but decreased sub-retinal fluid, along with the same criteria of the extended treatment regimen. From weeks 16 to 96, the minimum interval was 8 weeks, while the maximum interval was 16 weeks. “We have experienced that there is a proportion of eyes that just cannot dry up completely, but their vision is stable, they don’t have new fluid, or new hemorrhage,”

Posterior Segment

said Dr. Gemmy Cheung, Senior Consultant Ophthalmologist at the Singapore National Eye Centre (SNEC) and a Clinician Investigator at the Singapore Eye Research Institute (SERI). “There might be a bit of residual fluid, but this is actually decreasing and vision is stable, there are no other signs of activity.” At the primary endpoint (52 weeks) rapid vision gains were achieved in both treatment groups, and mean injections were similar (7.2 in 2-week group and 6.9 in 4-week group). These vision gains were maintained until week 96, while the number of injections continued to drop (3.6 in 2-week group and 3.7 in 4-week group). Around 30% of patients gained ≥15 ETDRS (3 lines of vision) in both treatment groups at week 52 and week 96. Fifty-seven to 60% of patients were maintained with injection intervals of 12 weeks or beyond at week 96. “Over 40% percent of patients, those who do very, very well reach the maximum retreatment level of 16 weeks,” said Dr. Cheung. “Data from ALTAIR underlines the efficacy of proactive T&E with aflibercept Cont. on Page 10 >>

ESCRS Satellite Symposium

SPEAKERS

Optimizing Your Clinical Practice With OCT and OCT Angiography Sunday, September 23, 2018 from 1pm - 2pm Reed Messe Congress Center, Room: Lehar 2 Lunch Boxes Provided

Vincent Borderie, MD, PhD France - Moderator

Maria Cristina Savastano, MD Italy

Frank Goes Jr., MD Belgium

Luca Di Antonio, MD, PhD Italy

Discover Optovue’s latest technology at EURETINA & ESCRS stand N° B203 To register for this event: www.optovue.com/escrs-symposium

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22 September 2018 | Vienna, Austria

Alternative Treatments to Inhibit VEGF in Age-related Choroidal Neovascularization

Update from the 5-year

IVAN! A great name for a successful bodybuilder, or a trial.

by John Butcher

n day two of the 18th EURETINA Congress in Vienna (September 21), congress attendees were given an update on the Inhibition of VEGF in Age-related choroidal Neovascularisation (IVAN) trial, which compared the effectiveness of bevacizumab and ranibizumab with different regimens in treating age-related macular degeneration (AMD). The original trial ran from 2008 to 2012 in the United Kingdom, Dr. Usha Chakravarthy, professor of ophthalmology at Queen’s University of Belfast, Royal Victoria Hospital, Belfast, Northern Ireland, told the audience. The said study looked at alternative treatments to inhibit VEGF in age-related choroidal neovascularisation (CNV), she added, comparing the drugs bevacizumab and ranibizumab, both with continuous and intermittent treatment. After patients exited the trial in 2012, the IVAN trial was allowed to continue collecting data on any patients who did not explicitly request to leave the trial

until 2017, she said. That included 199 who actively remained part of the trial via follow-up check-ups and a further 333 who did not actively engage with the trial but did not opt out. The trial was allowed to collect data from those patients passively, via the UK National Health Service (NHS) clinics they attended. The main aims of the extended trial, according to Dr. Chakravarthy, were to explore the effects of drug and treatment allocation on long term visual acuity, high related quality of life and mortality, describe long term management of patients receiving anti-VEGF therapy and explore the influence of visual acuity within the study. The initial IVAN grading had limitations, she told the audience. With no distinction between true geographic atrophy and regions occupied by atrophic neovascular lesions, and retinal angiomatous proliferation phenotype not separated. Subsequently, the grading system was revised to solve these issues. The follow-up study came to a number of conclusions, according to Dr. Chakravarthy. The IVAN trial’s treatment drug assignment and frequency did not influence visual acuity outcomes in the longer term. Also, half of all the study eyes were not on active treatment by the end of five years of follow-up. Risk factors for cessation of monitoring were age and lower

IVAN Trial best corrected visual acuity, she added. Visual acuity of study eyes dropped by around two lines during the extended followup, shared Dr. Chakravarthy. And the drop in visual acuity was similar in all visual acuity categories of the IVAN trial exit, she added. Three-quarters of all classifiable study eyes had internal limiting membrane (ILM) detected during the follow-up and this was not affected by treatment frequency, emphasized Dr. Chakravarthy. Study eyes with ILM had reduced limbload asymmetry (LLA) compared to those without ILM, she continued. The take home from the follow up study for ophthalmologists were several she continued. It demonstrated slow progress of vision loss in eyes with neovascular AMD on long term anti-VEGF treatments. Treatment cessation occurs in around half of those who started treatment within seven years, she added.

Dr. Usha Chakravarthy

In addition, macular atrophy is common in eyes receiving anti-VEGF, according to the study’s findings she said. And functional deficits are greater in eyes with neovascular AMD with macular atrophy compared to eyes without macula atrophy. When asked about what the correct response to patients who ask what to expect from AMD in the coming years, she said, in terms of long term counselling regarding treatment with anti-VEGF, they should be told they will have a better vision with it, than without it. But they should also be told they will not be able to continue driving or reading in the long term, she added. “They will have navigational functions,” she said, “Shopping, catching a bus, they will be able to do. But they will not retain the functions you need for fine tasks.”

PIE Magazine’s Daily Congress News on the

Posterior Segment

The Kreissig Award Lecture:

Dr. Antonia M. Joussen

by Brooke Herron

main highlight of any congress are the prestigious award lectures. At the EURETINA 2018 Congress, the Kreissig Award is given for outstanding contributions in the understanding and treatment of retinal diseases. This year, Antonia M. Joussen, MD, PhD, was the recipient of the award and presented her research on “Diabetic Retinopathy: A neuroinflammatory disorder?”. Dr. Joussen is a professor of ophthalmology and director of the Department of Ophthalmology, Charité University Medicine Berlin and Berlin Institute of Health in Germany. With a focus on ocular angiogenesis and a major interest in diabetic retinopathy, she has been recognized for her contributions to the field. In her presentation, she asks: Is inflammation in the diabetic retina causal or an epiphenomenon? To determine this, Dr. Joussen begins with what we know thus far. First, she says pericyte loss is an early

Insights into Inflammation in Diabetic Retinopathy event in diabetic retinopathy and that this pericyte depletion (platelet-derived growth factor or PDGF antibody) directly induces inflammatory responses in endothelial cells (ECs) and infiltration of macrophages. Hyperfluorescent dots and foci in diabetic retinopathy create a bit of controversy, as they do not disappear early after vascular endothelial growth factor (VEGF) inhibition. “This is the beginning of what we know – the first sign is the loss of pericytes,” said Dr. Joussen. “If you lose pericytes endothelial cells can proliferate.” Leukocytes also play a role: “These leukocytes that are inside the vessels and do the damage . . . these are the ones that produce the VEGF,” she added. Microglia cells should also be noted, as Dr. Joussen says that in diabetes there are different stages of activation of these cells. “We have the privileged stage where cells are just starting to become activated. Then you have the comprised stage that leads to chronic inflammation,” she continued. Her program delved deeply into the science behind the disease, covering

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different diabetic models in mice and rats, as well as prescribed methods to investigate inflammation. But perhaps what’s most interesting centers around what she describes as “tasks for the future.” One task described by Dr. Joussen is investigating the relationship between diabetes in the retina, in relation to fat tissue, the brain and kidneys. And what she disclosed was the gene expression of inflammation in the retina is similar compared to inflammation in the kidneys. “If you discuss diabetes, you’re aware the kidneys should be affected. You can see the diabetic mice have some damage, while that may not be of interest to ophthalmologists at first, we see that the gene expression of inflammation in the kidney and retina are similar,” she said. So, is this inflammation a friend or foe? A little bit of both, according to Dr. Joussen. “Initially there is some beneficial inflammation, later when it becomes excessive it becomes destructive. You need some inflammation to get rid of exudation,” she concluded.

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22 September 2018 | Vienna, Austria

Cont. from Page 7 >>

over two years of treatment in patients with nAMD. It has demonstrated considerable visual gains at the end of the first year, which is well maintained at the end of the second year, at the same time with a significant reduction in the number of injections, particularly seen in the second year.” In addition, the safety profile of intravitreal aflibercept in ALTAIR is consistent with results in previous studies.

The ARIES Study ARIES is a Phase IIIb/IV study designed to investigate the efficacy of aflibercept with early (initiated after the first 8-week treatment interval) versus late initiation (at year one) of a T&E dosing regimen in patients with nAMD. This was a multi-center, open-label, active-controlled, parallel group, Phase V study in treatment-naïve patients with nAMD. Patients were randomized at week 16 into either “early start” aflibercept 2mg with a two-week interval extension, or “late

start” aflibercept 2 mg Q8 regimen. At 52 weeks, a mandatory visit was required and the late start group began a two-week interval extension. The study found that rapid vision gains were maintained to week 52 and were similar in both groups. The mean change in BCVA from baseline to week 52 was +6.8 letters in the early start group and +8.4 in the late start group. These results were parallel and the difference in BCVA was attributed to baseline characteristics rather than the treatment regimen. Professor Paul Mitchell, University of Sydney, Australia,

notes that any changes in CRT were also due to differences in baseline characteristics. Additionally, around 98% of patients maintained vision from baseline in ARIES, which is consistent with aflibercept-treated patients in the VIEW trials. “In summary, preliminary data from ARIES corroborates existing evidence supporting the suitability of aflibercept for early proactive treat and extend regimen, with 52-week analysis the visual and anatomic outcomes were similar in patients in both early start and late start,” concluded Prof. Mitchell. Overall, the dual mechanism of action and high binding affinity of aflibercept, and its sustained suppression of intraocular VEGF, make it suitable for a proactive T&E dosing regimen in nAMD. In addition, in clinical practice, proactive T&E dosing with aflibercept starting in year one is associated with rapid vision gains that are maintained thereafter with a reduced treatment burden.

Ophthalmic Industry Partners Unite at the 18th EURETINA Congress

PIE Magazine’s Daily Congress News on the

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Announcing a Symphony of Surgical Instrument Innovation by Brooke Herron

evelopment in ophthalmic instruments has grown exponentially in recent years. The posterior segment arena of the ophthalmic word has benefited tremendously from the resulting byproduct of such growth: innovation. Dr. David Chow, assistant professor, Ophthalmology and Vision Sciences, University of Toronto, presented attendees at the 18th EURETINA Congress in Vienna with a truly informative technological update covering these new tools.

Cutters The Ultravit 10K Bevel High Speed Probe from Alcon: This 10,000 cpm high speed probe with a dual pneumatic drive features bevel tip design which allows the cutting port to get closer to the retina. The Two Dimensional Cutter by DORC can double cut and double aspirate with each cycle. This makes it more efficient (its 92% duty cycle creates constant aspiration flow independent cut speed) and safer (reduced traction on surrounding tissue with double cuts and no surges turbulence). Plus, the aspiration flow is three times higher than the standard cutter. The Bi-Blade Dual Port Vitrectomy Cutter from Bausch & Lomb has innovative dual blade design which allows for two cuts per duty cycle, 15,000 cpm, consistent flow rates, reduced retinal traction. In addition, it’s available in 25- and 27-gauge. The Hypervit Dual Blade Vitrectomy Probe from Alcon features dual blade and bevel tip design for two cuts per duty cycle, 20,000 cpm, consistent flow rates and reduced retinal traction. Twenty-five and 27-gauge variations are available. The Vitesse Hypersonic Vitrectomy from Bausch & Lomb brings a new cutting concept with a needle mounted to a piezoelectric US tranducer which vibrates harmonically for 1.7 million cuts per minute. The instrument provides tissue liquefaction

at the edge of the port, control and precision (the vitreous is aspirated through the open port) and constant flow (the vitreous is aspirated up the unobstructed lumen).

Illumination Enhanced 27G Light Fibres from DORC will increase light output by 65% (compared to current 27G fibers) and includes a transscleral illuminated depressor option and shielded, focal and total view fibers. The Laser Light Source from Vitreq brings multiple innovations. It has three laser light diodes and high power output capability (80 lumens). It also includes capabilities for smaller light fibers and tunable color.

Accessory Lines Another new device from Vitreq is the Retractable Tissue Manipulator. Its brush tip is designed for atraumatic brushing of the retinal surface, with a unique “rib structure” to manipulate the retina. It creates no diamond dust and has a retractable design for valved cannulas. Katalyst brings its Maeno-Awh Super Manipulator for ILM flaps, featuring atraumatic rubber sphere at the end of a soft silicone tip to push and hold ILM in macular holes. Plus, its sliding T tube technology adds ease of insertion in valved cannulas. The Disposable Backflush is another development from DORC. It has blunt, soft

brush tips, reduced actuation force and slimline design for less interference BIOM. Bausch & Lomb introduces its High Flow VFI Cannulas which will decrease silicone oil injection time. It’s available in 20-, 23- and 25-gauge, and the 23- and 25-gauge versions fit into the standard trocar/cannulas for the same gauge.

Scleral Depressors The Scleral Depressor Marker by Lyubomyr Lytvynchuk is indicated for retinal detachment surgery. It allows for simultaneous indentation and marking of the desired area during scleral buckling surgery, while its squeeze handle exposes the inner tube with a serrated surface that is coated with a skin marker. There is also an illumination option using 23-29G chandelier fiber, which allows more precise marking of breaks. Gary Ganiban won the ASRS Winning Pitch Competition in 2018 for his “Ganihand” Hands Free Scleral Depressor. It features hands-free scleral depression with three components: semi-hemispherical scleral depressor element that matches the radius curvature of the globe; a vertical arm to place it in the Fornix; and a bendable superior arm for an assistant to hold, or to attach to the lid speculum. These are, of course, just a sample of what’s new in ophthalmic instrumentation – innovations that make surgery safer for patients, and better for doctors.

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22 September 2018 | Vienna, Austria

Drugs, Tech and Investment

Could See a New Dawn in AMD Treatment by John Butcher

Dr. Robyn Guymer

ew advances in drugs and technology could be imminent that would have a significant impact on tackling age-related macular degeneration (AMD), experts said at one of yesterday’s main sessions at the 18th EURETINA Congress in Vienna. They include anti-vascular endothelial growth factor (anti-VEGF) agents and non-destructive lasers currently under trial that could improve patient care, patient outcome and reduce costs, speakers said. The “marching death of atrophy” is the natural progression of AMD, according to Dr. Frank Holz, Chairman and Professor at the Department of Ophthalmology, University of Bonn, but the speed with which it advances is extremely variable between patients and has therefore been unpredictable. Advances are being made in identifying markers that can predict the progress of AMD though, he said, and money is being allocated towards studying the disease. They include the MACUSTAR Project, which is being jointly funded by the European Union and private companies, and will have twenty clinical sites across Europe. “The project hopes to learn new things about intermediate AMD, with the ultimate

Dr. Pravin Dugel

aim of preventing progression to the late stages of the condition,” said Dr. Holz. Dr. Robyn Guymer, a professor at the University of Melbourne, told the audience about new nanosecond laser technology that has shown positive results in treating AMD during trials. The 2RT laser can be used to treat AMD on the theory that it arises because of deficiency in the normal turnover of Bruch’s membrane extracellular matrix due to insufficient levels of active matrix metalloproteinase enzymes, shared Dr. Guymer. It aims to trigger photo-regeneration of the retinal pigment epithelium (RPE) using three second nano-pulses and a speckled beam that targets individual RPE cells. The laser is non-thermal and studies suggest there is no collateral damage from it, unlike regular clinical lasers, she told the audience. Results so far suggest the laser has the potential to reduce progression to late stage AMD, she added, although further trials are needed. “If the results are validated they will be highly clinically meaningful,” she said. Her enthusiasm for results using the laser was backed by Erica Fletcher, a professor in the Department of Anatomy and Neuroscience at The University of Melbourne, who was

involved in trials of the laser using mice and human eyes. The laser induces selective ablation of the RPE which heals over a matter of days, she said. It appears to cause changes within the RPE that reduce aging, she added, and reduces the thickness of the Bruch’s membrane without using heat. “The laser has a lot of potential for the treatment of intermediate AMD,” she said. Dr. Pravin Dugel, managing partner at Retinal Consultants of Arizona, told the congress that new and improved antiVEGF treatments are “coming down the pipeline.” They include a range of drugs that are in trials, he said, as well as new delivery systems. Trials of anti-VEGF drug brolucizumab have proved positive, and combination therapies are being developed with encouraging results, he said. New drug delivery systems that could make treatment more palatable for patients are also being developed, he added, including micro pumps that can be inserted into the eye to deliver treatment without the need to see a physician. “You have seen a taste of all the wonderful things we have in the pipeline,” Dr. Dugel told the congress delegation. “We have wonderful drugs coming and I can’t think of a better time to be in our field.”

Mozart Says

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Patients Win with Artificial Intelligence The concept that we “can take menial tasks out of our day and enhance our capabilities, I think that’s a win.

”

- Mr. Jim Mazzo, global president of ophthalmology for Carl Zeiss Meditec “Mozart” (left) and Jim Mazzo (right)

by Brooke Herron

ith EURETINA 2018 taking place in Vienna, we’ve not only thought about Mozart and what he would do as an ophthalmologist, but we’ve also posed that question to key thought leaders in the industry. One such leader is Jim Mazzo, global president of ophthalmology for Carl Zeiss Meditec, who spoke with us about Mozart, time management and artificial intelligence (AI). “One thing about Mozart is that he was very creative – he put a lot of things together to really create a masterpiece,” said Mr. Mazzo. “Today, doctors really have to create a masterpiece with technology because they don’t have the availability, they don’t have the time to see every one of the patients.” He says this is because there’s a tremendous phenomenon where there are more patients and fewer doctors. “So, if Mozart was around today, he would have all kind of music flowing at him, and the question is: Would he be able to write it all down? And if he can’t write it all down he doesn’t have a masterpiece,” he continued. However, Mr. Mazzo sees help on the horizon in the form of artificial intelligence

(AI) – or more specifically just “intelligence.” “I’m not sure if it’s artificial intelligence, so let’s just work with the word intelligence . . . I think the term AI is being overused today for really just having intelligent data at their hands,” he explained. “The concept of artificial intelligence is to take menial tasks out of our day-to-day – to be able to unleash our brain.” “There’s a statistic that we only use 10 to 20 percent of our brain, if we can use AI to take some of the menial tasks out of our great physician’s hands and allow them to use more of the capacity of their brain, the patient wins,” said Mr. Mazzo. It’s been said that Mozart used 30 percent of his brain, and we can agree that he was clearly a genius. So, with AI could we get him up to 40 percent if we removed the menial tasks from his day? Perhaps. “The concept that we can take menial tasks out of our day and enhance our capabilities, I think that’s a win,” explained Mr. Mazzo. “But again, that goes back to my premise, there are more patients and less doctors – they have to have information in their hand. At Zeiss we’re providing that information so that he or she can better treat the patient.” He says this is about easy access information. Whether that means it’s artificial

intelligence or just intelligence – overall, it’s simply using correct information to make the right decision. Mr. Mazzo agrees that the posterior segment is ripe for the use of AI: “Think of where your retinal physicians are, there aren’t a lot of them across the globe and in fact, it’s a very condensed environment.” “They’re challenged with a disease that really has no known cure today . . . they’re challenged by compliance,” he continued. “So, they’re constantly challenged by menial things that really reduce their effectiveness. If we can help them to be able to reduce the complexity of their position and be able to unleash that power, how much more effective could they be?” And Mozart, with his superior intelligence, would have been even more effective with the reduction of menial tasks: “Think about the type of music he would have been able to make if we could have taken the menial tasks out of his day-to-day operation.” “If we could unleash more brain capacity, or just more time in our day, to be able to really make critical decisions, who wins? The patient wins,” said Mr. Mazzo. Editor’s Note: The interview with Jim Mazzo is part of the PIE Talks series at EURETINA (coming soon).

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22 September 2018 | Vienna, Austria

Experience the Eye Like Never Before!

by Hazlin Hassan

ondering what to do in between sessions? Come and visit the Alcon booth at B201 at the 18th EURETINA Congress this year for the latest in cutting edge technologies in ophthalmology. The virtual reality experience will show you the most progressive technologies. You may put on the virtual reality (VR) headgear and choose to watch videos of surgeries or interviews with surgeons sharing their experiences using Alcon’s latest tools. Alcon’s wide range of equipment are also on display, so don’t miss the opportunity to get your first-hand experience with machines ranging from the NGENUITY 3D Visualization system to the VerifEye Lynk & VERION 3.1 Image Guided System, part of the industryleading Cataract Refractive Diagnostics Portfolio by Alcon. The booth comprises three areas: the vitreo-retinal, cataract and advanced technology, to enable surgeons to get to know the latest up-to-date technology in the Alcon portfolio. There is a 3D-elevated experience

where surgeons will answer three questions related to his surgical techniques, such as the gauge size of the cutter he is using in daily procedures, cutter speed, and visualization system. Based on his responses, he will then go through a customized 3D presentation highlighting the key benefits of Alcon’s technologies starting from the NGENUITY 3D Visualization system, and DATAFUSION software. For those wanting to check out the Finesse SHARKSKIN ILM Forceps, the booth has these on display. Carefully handmade by Alcon employees at Grieshaber, the forceps have a unique pattern on the metal tip to make it easier to grip fine membranes. Specialists can also check out the LuxOR LX3 Ophthalmic Microscope, a diagnostics machine for cataracts and to maximise patients’ visual outcome and to execute a treatment plan during and after surgery. Also on hand is the WaveLight vision correction system, which takes thorough and precise measurements of the eye and takes the guesswork out of refractive eye surgery. This helps surgeons determine personalized patient treatment paths.

For those who have yet to experience the NGENUITY 3D Visualization system, there is a demonstration video where you may don the 3D glasses and watch surgeries in all of their 3D glory. Many surgeons never want to go back once they go 3D! There are also wet labs for training in cataract and retina – designed to enhance learning by simulating ocular surgical procedures. Don’t forget to book your appointment for the wet lab. And if you are feeling a bit peckish after having tried all the activities, there is a bar serving coffee and refreshments where you can relax and unwind. “The booth is very pleasing from afar and accessible. The equipment is first class, one for the future. I find the NGENUITY 3D Visualization System interesting, that is something new, and will solve a lot of problems during surgery,” said Dr. Dennis Sibanda, a congress delegate from Zimbabwe. Dr. Charilaos Nichorlis, a delegate from Austria said: “The booth is very well-constructed. I like it very much. We use the Alcon CENTURION system, the INFINITI vision system. They are innovative and they work very well.”

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Visit Us at ESCRS-EURE TINA at Booth #C 518A