CAKE & PIE POST (ESCRS & ASRS 2021 Edition) - Issue 2

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ISSUE

10 | 10 | 21

HIGHLIGHTS present the latest 04 Experts in EDoF IOLs at ESCRS...

DMEK RAPID has 08 Geuder’s changed the landscape in lamellar transplantation treatments and 12 Better outcomes, on the horizon for DR ASRS 2020 Award 16 The winners, finally!

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On Spotlight at ASRS 2021

The Evolution of Diabetic Retinopathy Management and Treatment

by Brooke Herron

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W

hile currently there isn’t a cure for diabetic retinopathy (DR), researchers have been moving full steam ahead in developing new therapies to halt the progression and help manage this sight-threatening condition. Therefore, there were not one — but two — very informative sessions on the disease on Day 1 of the American Society of Retina Specialists (ASRS 2021) Scientific Meeting. Here, we’ll take a look at what was covered during the aptly named Diabetic Retinopathy Symposium 2, which focused on some emerging treatments, like gene therapy.

This session ran the better part of two hours, Cont. on Page 3 >>

GEUDER kindly invites you to a LIVE DEMO At ESCRS 2021 BOOTH NO. A42 / HALL 12 ONATEC OEX-1 Efficient Glaucoma Treatment with Suture Probe Canaloplasty Prof. Gábor B. Scharioth, MD Aurelios Augenzentrum, Recklinghausen, Germany Sunday, 10 Oct, 13:00 – 13:30

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10 October 2021 | Issue #2

Your surgical day, Just got easier.

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CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments

>> Cont. from Page 1

so unfortunately, this article serves as a “Cliffs Notes” version — so make sure to watch the full symposium on demand at your leisure. That said, let’s dive in!

Say hello to new(er) molecules Anti–vascular endothelial growth factor therapy (anti-VEGF) has been the firstline treatment for a variety of retinal conditions — and for good reason: It gets the job done. However, the treatment regimen can be burdensome, and some patients just don’t respond to the drug. So, in the quest to save sight, newer molecules, like faricimab and brolucizumab have been introduced into the potential paradigm — and we say, the more options, the better.

On faricimab was Dr. Caroline Baumal, who shared results from the YOSEMITE and RHINE trials which evaluated the efficacy, safety and durability in 1,891 diabetic macular edema patients (DME).

We’ll begin with a short description of the drug, as shared by Dr. Baumal: “Faricimab is the first bispecific antibody designed specifically for intraocular use.

It’s one molecule with two targets: It binds and neutralizes Ang-2 and VEGF-A, which are key drivers of vascular leakage, neovascularization and inflammation — and it’s this dual effect that may give rise to the potential for greater effect of vascular stability than anti-VEGF treatment alone.”

So, what did they find? According to Dr. Baumal, there were greater reductions in central subfield thickness and in faricimab-treated eyes — and more of the faricimab-treated eyes achieved absence of DME. Further — and importantly — “more faricimab patients achieved more absence of intraretinal fluid compared to aflibercept eyes at week 56, showing that there may be an additional edge of effectiveness from this bispecific unique molecule,” she added.

Indeed, the investigators found that “Faricimab was well-tolerated; intraocular inflammation event rates for faricimab were low (1.3% on average) and no cases of vasculitis or occlusive retinitis were reported.”

Next up, Dr. David Brown shared results

from the KESTREL and KITE studies, which evaluated the efficacy and safety of brolucizumab in DME. To summarize: In both studies, “brolucizumab offered robust vision gains and improved anatomical outcomes with more than 50% of DME patients maintained on a q12w treatment interval after loading through Week 52, and demonstrated an overall well-tolerated safety profile.”

Getting “gene-y” with it Gene therapy continues to create a big buzz for its potential to prolong treatment intervals and improve outcomes in certain conditions. As such, we were excited to hear about the first-time 24-week interim data from the INFINITY trial presented

by Dr. Charles Wykoff. This phase 2 study was designed to assess the durability, safety, tolerability and efficacy of a single IVT injection of ADVM-022 in patients with DME. According to Dr. Wykoff, ADVM-022 is a novel biofactory approach to gene therapy designed for continuous delivery of aflibercept following intravitreal injection. Unfortunately, not all went as planned. “INFINITY, importantly, was unmasked on May 4 due the development of a dose-limiting toxicity of hypotony necessitating surgery,” shared Dr. Wykoff, adding that this was the most unexpected, significant adverse effect.

In terms of visual acuity, he shared that improvements were observed until after week 24 — at that point, there was a downward trajectory in the high-dose population related to adverse events.

“When considering ocular adverse events, nearly all of the ADVM-022 treatment patients developed anterior IOI (intraocular inflammation), a majority developed an iris-related events, and a few had posterior IOI. “While these events were consistent with what has been reported in OPTIC, overall, the proportion of patients — and the intensity of these events — both appear to be meaningfully increased in this INFINITY dataset compared to OPTIC,” he continued, adding that there were three cases of hypotony, all in the highdose population, that required surgery.

He said that a comprehensive approach is underway to better understand these adverse events and this dose-loading toxicity. “From this interim analysis of the INFINITY study we have learned that ADVM-022 dose and disease state appear to play a very meaningful role in determining the therapeutic window to balance safety and efficacy,” said Dr. Wykoff. And due to these events, he concluded that moving forward, ADVM-022 development will focus on neovascular AMD and not DME, as well as lower doses of ADVM-022.

Short and sweet We’re low on space, but high on content — so bear with us while we summarize a few more key points.

Dr. Sophie Bakri presented data from a meta-analysis of five ranibizumab trials and asked: What is the clinical significance of improving diabetic retinopathy for vision outcomes? She reported that in “patients receiving monthly ranibizumab for DR, greater DR severity improvements were associated with better vision outcomes and reduction in CST.” Further, in these patients, greater DRSS (diabetic retinopathy severity scale) improvement was significantly associated with trends for better vision and anatomic outcomes.

Telemedicine has been increasing in use, and now, along with the development of artificial intelligence (AI), this combination could result in improved outcomes. On this topic, Dr. Andrew Barkmeier shared real world telemedicine outcomes for DR screening with AIbased image analysis, reflex dilation and image overread protocol in a primary care setting. While they found that most patients over 60-years-old require dilation for successful image interpretation, the main conclusion was this: “Combining AI-based image analysis with a formal reflex dilation protocol and manual overread of positive results may allow for safe and efficient DR screening — while minimizing follow-up clinic visits.”

For more on these topics — as well as the ones we just couldn’t fit in this space — make sure to check out the symposium on-demand.

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10 October 2021 | Issue #2

Boosting Range of Vision with the Latest in EDoF IOLs

by Hazlin Hassan

A

wide range of intraocular lenses (IOLs) and the latest in extended depth of focus (EDoF) IOLs were highlighted during the Industry Satellite Symposium sponsored by Teleon Surgical (Spankeren, The Netherlands) on Day 2 of the 39th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2021).

The past and the present of IOL technologies EDoF is a new technology that has recently emerged in presbyopia correction. In contrast to multifocal IOLs used in presbyopia treatment, EDoF lenses work by creating a single elongated focal point to enhance the range of vision or depth of focus.

Ramin Khoramnia, associate professor at the University of Heidelberg in Germany,

shared that historical options for presbyopia correction include monofocal IOLs, which provide full range of vision but can cause loss of depth perception, while the intermediate visual acuity is not optimal.

Multifocal IOLs are capable of creating multiple focal planes that allow for a fuller range of vision. But on the other hand, there is an increased chance for visual disturbances and reduced contrast sensitivity.

“These days, we have a very big variety of optical technologies that are available to create an extended depth of focus.

We can achieve this by diffractive technology, refractive technology or other approches and also the small aperture principle,” emphasized Prof.

Khoramnia.

For example, the TECNIS Symfony IOL

(Johnson & Johnson Vision, Santa Ana, California, USA), is one of the first EDoF lenses on the market and is based on a diffractive technology that extends focus.

“We are all aware that in terms of visual acuity results in far and intermediate distance, very good results can be achieved, but we are also aware of the fact that this diffractive technology goes along with an increased rate of visual disturbances, when compared to monofocal intraocular lenses,” Prof.

Khoramnia explained.

Further, he shared a paper in which one eye received the TECNIS Symfony IOL, and the other one, a bifocal IOL. The results were compared with patients who received trifocal IOLs. “The mix-and-match approach was a good option for patients with high demands in near and intermediate

CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments

distance, while trifocal IOLs provided a better option for patients with high demands for near distance,” reported Prof. Khoramnia.

“These days, we have a very big variety of optical technologies that are available to create an extended depth of focus.

We can achieve this by diffractive technology, refractive technology or other approches and also the small aperture principle.”

On refractive technology, he said that Teleon Surgical’s LENTIS Comfort offered excellent image quality, especially in the fine intermediate distance, and at the same time, functional vision can still be achieved in the near distance.

“We also assessed this lens in a clinical study, and you can see the excellent results are achieved in distance and in intermediate distance, and at the same time, functional visual acuity results are also achieved in the near distance,” he added.

Teleon also offers the Acunex Vario as a hydrophobic version of LENTIS Comfort, with the same optic technology. One of its advantages is the hydrophobic glisteningfree material that is used.

“In our laboratory, we have very often assessed the problem of glistenings.

And in this paper, we have been able to show that glistenings do go along with an increase in straylight. Therefore, in my opinion, I do not want to see anymore glistenings with monofocal lenses, and I certainly don’t want to see glistenings in lenses when patients pay a lot of extra money to get rid of their spectacles,” shared Prof. Khoramnia.

Another option, the AcuFocus IC-8 IOL (Irvine, California, USA) employs an opaque mask to create a small central aperture. In terms of the visual disturbance profile, very good results have been published, along with other advantages that can mask up to 1.5 diopters of astigmatism, but there are also some drawbacks to the lenses.

One drawback is the fact that quite a large 3.5mm incision is required. And there is also reduced mesopic contrast sensitivity, although this is partly mitigated by the monocular implantation.

Meanwhile even with an exhaustive list of IOLs, there is even more to look forward to in the future.

Talking about the new segment of enhanced monofocal IOLs, Prof.

Khoramnia said they achieve the good visual acuity results in intermediate distance but not as good as, for example, the Comfort EDoF lenses.

“If you look at the defocus curves, you can see that enhanced monofocal is able to provide about one line more visual acuity in comparison to monofocal intraocular lenses. What is very interesting about this enhanced monofocal class approach is that you are basically not losing any vision at the far distance, and that there are no photic phenomena. By virtue of that, this segment will more or less rapidly push all the monofocal lenses away from the market, and I think that in the near future we will only see enhanced monofocal lenses instead.” he noted.

“We are currently at the beginning of a very interesting phase in refractive surgery, certainly an excellent time to be a cataract and refractive surgeon, because we have so many options available. With enhanced monofocal technology, I really think that in the near future, we will not use traditional monofocal intraocular lenses. And with all the great presbyopia correcting options that we have available, I’m quite sure that we will see many more patients getting these lenses in the future,” Prof.

Khoramnia added.

A quantum leap for standard monofocal cataract surgery Teleon’s new LENTIS Quantum just launched at ESCRS is an enhanced monofocal IOL that offers significantly better vision in the intermediate area.

The lens is free from undesirable side effects and ensures the best contrast vision comparable with a conventional monofocal IOL. Dr. Detlev Breyer, lead surgeon of Breyer, Kaymak und Klabe Augenchirurgie, Dusseldorf, Germany, spoke about this latest innovation in the LENTIS IOL family.

“It may be a very good bridge product, to get more and more cataract surgeons toward premium IOL surgery because the risk of implanting a lens like this is very, very low. You don’t have any photopic phenomena, you only have advantages,” he said.

The basic Quantum EDoF principle is to create a single elongated focal point to enhance depth of focus. Teleon applies slope constraint Q-type asphericity for a progressive power profile neutral to spherical aberration in the eye, not adding spherical aberration, in contrast to other IOLs. “I do think that the Quantum really has an enhanced monofocal effect and the quality of vision is also excellent, it’s better than a standard monofocal IOL in all regards,” Dr. Breyer shared.

“With the LENTIS Quantum, we achieve a very high independence from glasses for intermediate distances, with a high safety level, and a high comfort level for the patients. What I like in comparison to diffractive IOLs, is that you have multiple treatment options,” he added.

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10 October 2021 | Issue #2

All About Advanced IOLs

by Tan Sher Lynn

T

he variety of intraocular lenses (IOLs) available today means that surgeons are more equipped to help their patients obtain the best option for their visual needs. Experts in cataract surgery talked about advanced IOLs and preoperative assessment considerations on the second day of the 39th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2021).

Innovations in preoperative assessment Dr. Arthur Cummings from Ireland noted that the past 18 months have seen dramatic changes where consumers and patients are spending discretionary income on themselves; healthcare and well-being have moved up the priority list; mask-wearing has driven demand for refractive surgery and refractive cataract surgery; and advanced technology intraocular lenses (AT-IOLs) are increasing at a pace never seen before.

According to him, three methods that can help the patient select the best option are having a lengthy interview/discussion, using the Dell questionnaire and objective visual data.

“Objective visual data is collected over a 36-hour minimum timeframe in the patient’s house and/or workspace and measures more than an interview, history or questionaire can provide. Subjective assessment such as interviews and questionnaires can be replaced by objective data obtained by devices, like the visual behavior monitor, worn at the spectacles which measures working distances, ambient lighting and head position,” he said.

An example is the Vivior Monitor which objectively measures patient behavior and matches it to the performance properties of a range of IOLs to compare monofocal, bifocal, extended depth of focus (EDoF) and trifocal IOLs to see how each of the modalities adds functionality

to the baseline.

“To further prepare for success, we need to make sure that the ocular surface is pristine; exclude poor topographic and tomographic cases; ensure that the macula and optic nerve are normal in optical coherence tomography (OCT); the vitreous is healthy; and the peripheral retina is normal. We can increase the odds of success with meticulous planning and execution of procedures; appropriate patient selection; appropriate IOL power and IOL design selection; opting for the procedure best suited to the patient; and under-promising and over-delivering (to surprise the patient positively),” he said.

IOL selection considerations “The evolution of multifocal lenses started in the early ‘80s when two IOLs of different power were sliced and parts of them were glued together in order to have a segmented, bifocal, refractive lens.

CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments

Today, we have over 100 different high performance IOLs in the market,” said the next speaker, Dr. Michael Amon from Vienna, Austria.

He stressed the importance of knowing the terminology for high performance IOLs in order to help patients select the best option. “EDoF IOLs are small aperture lenses only; increased range of focus (IRoF) IOLs utilize higher order aberrations with single focus point (which is reminiscent of “old school” aspheric IOLs); hybrid IOLs actively combine different optical principles with more than one focus point; and multifocal IOLs have the highest level of distance independent visual ability (DIVA),” he said.

“Positive or negative dysphotopsia may occur with any high performance IOL. All IOLs using more than one focus point create halos. The higher the level of DIVA, the higher the chance of photic phenomena. The level of DIVA also influences susceptibility on tilt, centration and contrast,” said Dr. Amon.

He noted that optical bench data are helpful in the understanding of optical IOL performance. “IOL manufacturers should provide standardized and precise technical information. And surgeons need to have profound knowledge of IOL optics for individual IOL selection while considering functional vision and patients’ needs,” he commented.

decades, are not optimal anymore as intermediate and near vision has become increasingly important. “EDoF technology increases spectacle independence by improving intermediate vision with minimal impact on the quality of distance vision, creating a visual zone instead of a focal point, and reducing halos and glare compared to trifocal IOLs.

Meanwhile, Dr. Pavel Stodulka from Czech Republic, noted that cataract patients are generally concerned over three things when selecting their IOL: the distance they can see, vision quality, and the risk of dysphotopsia.

“Having said that, EDoF lenses also have some dysphotopsia, which requires neural adaptation. Adaptation can happen sooner or later, which is individual and this needs to be conveyed to the patients upfront,” said Dr. Stodulka.

“Typically, monofocal lenses provide distance vision; EDoF/IRoF lenses cover distance and intermediate vision; bifocal lenses cover distance and near vision; while trifocal lenses cover all three distances, but at a high risk of dysphotopsia,” he said.

He stressed that proper IOL power calculation is mandatory to achieve emmetropia in at least one eye. “Also, the use of a capsular tension ring (CTR) can improve long-term IOL centration.

Besides, societies like the ESCRS should propose comparison criteria and proper terminology for EDoF, IRoF and other advanced monofocal IOLs,” he suggested.

He noted that monofocal lenses, which have served as the standard for many

Aye, Robot: The AI Hype

by Elisa DeMartino

A

rtificial intelligence (AI) continues to be an increasingly hyped topic worldwide. While we haven’t quite made it to the sci-fi-esque sentient robot stage yet, as depicted in the famed 2004 film starring Will Smith — and aren’t totally sure we ever want to be there, either — we benefit immensely in our daily lives from things like navigation systems, facial recognition and automated translators, which AI has hugely improved for everyday use.

When it comes to functions improved by intelligent technology, the healthcare industry is no exception.

The mainstream use of AI and machine learning in healthcare delivery has started to emerge, as more and more health practitioners recognize the potential of harnessing advanced technology to improve prevention, diagnosis and treatment; to extract more data from clinical trials; and to cut business costs.

Looking to jump on the AI bandwagon but not sure how? Zepplinq BV (Almelo, Overijssel, The Netherlands) is hanging around at the Amsterdam RAI this weekend to help tentative techies get started.

Their new service connects healthcare consumers, doctors, healthcare clinics, artificial intelligence providers and businesses together so that they get the most out of new technology. The platform lets doctors easily link with patients online with agenda and Zoom functionalities, apply the AI of their choice, and even boasts a freeof-charge anterior and posterior grading tool — ultimately meaning more revenue for their practice.

Prof. Dr. Kai Januschowski, ophthalmologist at Mount St. Peter Eye Clinic Trier/University

of Tuebingen, appreciates the datacentric edge Zepplinq gives him in his practice. “As an ophthalmologist it’s great that besides my manual reading of medical images based on my experience and anamnesis of the patient, I now have a choice of various AI suppliers with Zepplinq. This gives me just that little extra care when I make my conclusion.”

Zepplinq gives doctors, like Prof.

Januschowski, the control to deliver effective and transparent healthcare via validated AI-algorithms backed by medical professionals. If you’re at ESCRS, pop over to their booth at A9 to find out more!

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10 October 2021 | Issue #2

Forward to the DMEK FastFuture of Lamellar RAPID Transplants

by Elisa DeMartino

B

ack in May when ESCRS announced that its 2021 session would, unlike last year, be held in person, Geuder AG was one of the first companies to commit to a fully equipped booth as they had always done in the pre-COVID days of yore. This year though is special, because this Heidelberg-based German group celebrates its 70th anniversary of bringing surgical instruments to the table. A long-established sweetheart of the international ophthalmic community, Geuder offers more than 3,000 products in over 100 countries — so it’s no wonder why they have such an impressive and thorough booth at this esteemed event.

Geuder is gracing the 39th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2021) audience with three live demos this weekend and not a single one is worth

missing. Their first presentation on Saturday morning hosted a fascinating presentation by Prof. Peter Szurman of the Augenklinik in Sulzbach, Germany and the K. Heimann Eye Research Institute on the Advantages of Preloaded Descemet Membrane and Implantation Techniques.

Prof. Szurman cooperated with Geuder and the German Society for Tissue Transplantation to develop the DMEK RAPID, the first CE-certified DMEK preloading system. Prof. Szurman didn’t simply brief his audience on the nitty gritty of a procedure; he gave an up close and personal live viewing of what the enhanced operation would look like using Geuder’s system — carried out on a porcine eye, of course (while the expo is exciting, it’s not quite spicy enough for live surgeries).

While it’s quite a tough feat to duplicate in writing the excitement of the demo and the buzz of the small crowd that gathered to watch, Media MICE always delivers: We’ll be releasing a video on the informative demonstration a little later on. Our cameraman was positively chuffed to be tinkering with his brand new lens, so the video will boast some neat close-up shots that’ll make you feel like you were there, too!

The RAPID revolution Following Prof. Szurman’s demo, our journalist stuck around hoping to get a few extra words of wisdom from the expert himself and he didn’t disappoint in telling us how the system revolutionizes ophthalmology.

CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments

“In my opinion, it’s really a revolution because while implantation is very quickly learned from experience for anterior segment surgeons, the preparation still poses a problem. A problem with transplant loss, when the patient is already prepared for surgery and the transplant is lost, then you have to cancel everything. But now they have put all the preparation process in a clean room where specialized personnel are pre-stripping and pre-loading the lamellae into a patented implantation cartridge. And the surgeon can only take it out of the package and the lamellae is already ready to use and you can directly implant [it].”

“The old technique was not really a minimally invasive technique; it had a long healing time. Now with DMEK, we have the chance to heal and to cure corneal patients within a few minutes.”

Corneal transplantation has existed as a tricky operation since the early 1800s, and for the first time it’s evolved into a streamlined process that’s easier for both the surgeon and the patient. By loading the lamellae into a single-use transportation cartridge, Geuder eliminates the need for preoperative preparation of the membrane while providing a no-touch handling process that maximizes endothelial cell

count. The RAPID system, which stands for “Revolutionary Advanced Preloading Injection Device,” also includes two plugs, a transportation holder for the cartridge, and a connection for loading it.

“Now the unclear process of preparation is put to the specialized personnel and the surgeon can concentrate only on his main business: the implantation. So the DMEK turns into a 10-minute quick procedure.” As goes the rule, less time in the OR means less opportunities for complications and also an easier workload for the surgeon.

Prof. Szurman went on to highlight how his collaborative system evolved from the traditional corneal transplant. “Full transplant surgery has been done less and less and it turns out that DMEK surgery is usable in 90% of cornea transplantation surgeries,” he explained, “The old technique was not really a minimally invasive technique; it had a long healing time. Now with DMEK, we have the chance to heal and to cure corneal patients within a few minutes.”

Yet it isn’t just about how this neat equipment helps surgeons. Eye banks benefit too, with improved workflow, a new level of standardization, the same no-touch method and, perhaps most importantly, by granting these facilities the ability to respond to increasing demand for pre-cut tissues.

RAPID lets eye banks support surgeons with high quality, ready-to-use grafts.

“We need to establish specialized tissue banks in all countries that prepare the tissue and that can be

distributed to every corneal surgeon, or even anterior segment surgeon, in the world.” Prof. Szurman commented on the importance of the role of eye banks in optimizing the preloading system. “In Germany we finished.

It’s validated and it has taken about a year. In every country we need such a validation process, but the tissue banks are specialized in these admission processes.” The expert says Geuder has rolled out in Germany, the Netherlands and Italy, but hopes to soon take the DMEK RAPID to the rest of the world.

In addition to hosting a second demo on Saturday afternoon with Prof.

Michael Amon from the Krankenhaus der Barmherzigen Brüder in Vienna, speaking on Simplifying Intrascleral IOL Fixation with 2-in-1 Forceps Needle, Geuder will showcase one more product on Sunday: Prof.

Gábor B. Scharioth from Aurelios Augenzentrum, Recklinghausen, Germany will talk about efficient glaucoma treatment with suture probe canaloplasty using the Onatec OEX-1.

“We need to establish specialized tissue banks in all countries that prepare the tissue and that can be distributed to every corneal surgeon, or even anterior segment surgeon, in the world.”

It’s exciting to once again witness Geuder’s innovative products showcased at an ophthalmology conference, and Prof. Szurman is no exception to the sentiment. “I think we are all incredibly happy that at the end, we can meet each other. An online congress of course helps, but we were all eager to communicate again.” So be sure to take advantage and check out Geuder’s platform before ESCRS concludes!

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10 October 2021 | Issue #2

Individualized Cross-Linking Room for Improvement

by Sam McCommon

functionality many other devices don’t.

For example, it has an eye tracker that allows the user to draw on the screen where they’d like to adjust energy use and the treatment zone diameter, create shapes, and more.

Dr. Behndig pointed out that the Dresden protocol, first published in 2003, is a fairly old treatment, and nothing is so good that it can’t be updated.

Before treatment begins, Dr. Behndig retrieves data from the Pentacam HR® (Oculus Optikgeräte GmbH, Wetzlar, Germany). The treatment zone size and location are determined by the size, form and location of the keratoconus cone.

In terms of energy use, the worse the keratoconus, the more energy needs to be used — anywhere from 7.2-15.0 Joules/ cm², which are quite high levels.

How well do you reckon this fella can see through the fence?

D

ay 2 of the 39th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2021) featured a discussion on advances in corneal cross-linking that delved into advances in the field. As approximately 1 in 2000 individuals are diagnosed with keratoconus, treating the condition with corneal cross-linking is clearly a crucial treatment. Even with current success rates upwards of 90%, there’s still always room for improvement.

Here, we’ll cover a talk by one of the hosts of the symposium on how customizing cross-linking (CXL) can improve outcomes and just how to go about it.

Customized CXL Because no two eyes are alike, and no two keratoconus cases are alike, individualized treatment makes good sense. This is the argument brought to

us by Dr. Anders Behndig, professor of ophthalmology and clinical science at the University of Umea in Sweden.

As Dr. Behndig pointed out, keratoconus is an individual disease — so individual treatments make sense. For example, some patients come quite late for keratoconus treatment, so they’ll need a different treatment regime than someone whose condition was caught early in its development. These individualized treatments can be guided by topography and tomography, with the aim of controlling and enhancing the refractive improvement seen after CXL. Dr. Behndig informed us that, while there are many devices available for CXL, the only device that’s capable of handling individualized treatments is the Mosaic® device by Glaukos (San Clemente, California, USA). It’s a hefty device — “a monster of a machine” as described

by Dr. Behndig — because it has

But individualized CXL shows refractive advantages over conventional CXL in keratoconus, said Dr. Behndig. A higher energy level makes for a deeper treatment and more crosslinks as well as a stiffer cornea. Higher treatment also gives a deeper demarcation line, likely meaning more crosslinks in the deeper part of the cornea and more stabilization and flattening in the cornea. In addition to the effects of riboflavin concentration, other factors may be at play in the effects of the CXL treatment.

One of those other factors is certainly oxygen. The chemical reaction behind CXL is oxygen-dependent, as oxygen is a rate limiting factor in the in vivo reaction.

While using room-level air may not produce adequate effects, flushing extra oxygen around the cornea improves the effects. Simply put, more oxygen gives more cross-linking, especially in epi-on treatment.

Patients of Dr. Behndig’s regimen showed lower pain scores than with an epi-off treatment, as well as improved visual acuity across the board.

In short, as Dr. Behndig summarized, CXL is a promising approach with more improvement in both corrected and uncorrected visual acuity. Additionally, a high-oxygen, epi-on protocol may comprise an additional improvement on cross-linking, in general. Isn’t it nice when we make measured, controlled steps in the right direction?

CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments

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ForeseeHome is a registered trademark, and the ForeseeHome AMD Monitoring Program and logo and the Notal Vision logo are trademarks of Notal Vision. © 2021 Notal Vision, Inc. All rights reserved.

References: 1. Ho AC, Kleinman DM, Lum FC, et al. Baseline Visual Acuity at Wet AMD Diagnosis Predicts Long-Term Vision Outcomes: An Analysis of the IRIS Registry. Ophthalmic Surg Lasers Imaging Retina.

2020;51:633-639. 2. Real-World Performance of a Self-Operated Home Monitoring System for Early Detection of Neovascular AMD (ForeseeHome device), presented by Allen Ho, American Society of Retina Specialist Meeting 2020.

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10 October 2021 | Issue #2

Dexamethasone may improve outcomes for DME Early treatment with dexamethasone appears to improve visual and anatomic outcomes in real world patients with suboptimal response to anti-VEGF for diabetic macular edema, said Dr. Shawn Kavoussi, retinal surgeon and founder of the Texas Retina Center.

This was a multicenter, retrospective series that included 58 consecutive treatment-naïve patients with a < 200µm reduction in central retinal thickness (CRT) and/or < 5 ETDRS letters gain after 1-3 intravitreal bevacizumab or aflibercept; these patients were then switched to dexamethasone with ≥ 6 weeks subsequent follow-up.

New Findings in DR Could Unlock the Key to Better Treatments and Outcomes

by Hazlin Hassan

R

esults from some of the latest studies on diabetic retinopathy (DR) were presented during a symposium on Day 1 of the American Society of Retina Specialists (ASRS 2021) Scientific Meeting on October 9.

High number of patients skip follow-ups Many patients with proliferative diabetic retinopathy (PDR) who are treated with anti-VEGF therapy and/or panretinal photocoagulation (PRP) in the United States are skipping their follow-up treatments. And when patients are lost to follow-up, the ideal care is not delivered and patients likely suffer irreversible vision loss, said Rahul Khurana, clinical associate professor in ophthalmology at the UCSF Medical Center, USA. To illustrate this point, Prof. Khurana shared the results of a study aimed at determining the incidence of loss to follow-up in patients with PDR who were treated with anti-VEGF injections and/ or PRP in the U.S. The retrospective

cohort analysis involved 102,867 eyes of patients with PDR identified from the national IRIS Registry. These patients were newly diagnosed between January 1, 2013 and December 31, 2015 and treated with anti-VEGF therapy and/ or PRP between January 1, 2013 and December 31, 2018. Loss to follow-up (LTFU) was defined as an interval greater than 12 months from the last treatment.

Results showed that for PDR patients treated with anti-VEGF therapy alone, 10.7% of patients were LTFU. For PDR patients treated with PRP alone, 9.5% of patients were LTFU. For PDR treated with anti-VEGF and PRP, 9.8% of patients were LTFU. This shows a significant rate of LTFU after anti-VEGF injections and PRP among patients with PDR. Identified risk factors include: increasing age, male sex, African American and Hispanic ethnicity, unilateral involvement and private insurance.

“Improving treatment adherence and follow-up is critical to prevent vision loss in PDR,” concluded Prof. Khurana.

In this cohort, patients with DME who had a limited visual and anatomic response to 1-3 monthly doses of either intravitreal bevacizumab or aflibercept demonstrated significant improvements after subsequent treatment with the dexamethasone 0.7 mg implant. “Earlier intervention with dexamethasone for treating DME may result in more rapid visual and anatomic gains compared to AVF monotherapy in certain patients,” said Dr. Kavoussi.

Oral drug APX3330 safe for DR and DME APX3330, a novel oral drug in development for the treatment of DR, has demonstrated a favorable safety and tolerability profile in eleven phase 1 and 2 studies, said Dr. Michael Allingham, retinal specialist, Duke Eye Center, United States.

APX3330 has an anti-angiogenic and anti-inflammatory mechanism relevant to the treatment of retinal disease. Safety data for the drug were collected from over 300 subjects receiving oral APX3330 in support of ZETA-1, an ongoing, randomized, placebo-controlled clinical trial evaluating the efficacy of 600mg/ day APX3330 for the treatment of DR and DME. “Currently, approved therapies targeting DR at the earlier stages require intravitreal injection, and thus, early non-invasive interventions targeting DR represent a clinical unmet need,” said Dr. Allingham. “APX3330 is a candidate to fill this niche.”

CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments

Walking the Tightrope Between Treatment and Ocular Toxicity

by Olawale Salami

Small molecules and the suprachoroidal space According to Dr. James C. Major, assistant professor of clinical ophthalmology at Houston Methodist, The suprachoroidal space has several interesting features, making it a very attractive target for drug delivery.

“We are all now familiar with the suprachoroidal space and the microinjector that goes with it, whereby drugs and small molecules zipper around the eye when injected interiorly,” he said.

However, key questions remain unanswered: how do drugs navigate this space and how is the durability of injected therapies ensured?

Dr. Major and his colleagues conducted experiments aiming to answer these questions.

T

he Pharmacology Symposium On Day 1 of the American Society of Retina Specialists (ASRS 2021) Scientific Meeting on October 9, highlighted the pros and cons of popular medical treatments in some eye threatening conditions. Below are some of the highlights during the session...

On PPS and interstitial cystitis Long term pentosan polysulfate use in the treatment of interstitial cystitis medication is associated with visionthreatening maculopathy.

“We always have to weigh the risks of vision loss from maculopathy against the potential benefits in interstitial cystitis,” said Dr . Nieraj Jain of the Emory University Eye Centre, (Georgia, USA).

“Given that it is the only FDA approved treatment for interstitial cystitis, thousands of patients are at risk and prospective data are needed regarding the long term visual impact of this condition,” said Dr. Jain.

“In my experience with these patients, even though they can read the eye charts, they’re really struggling,” he added.

During his presentation, Dr. Jain shared a prospective study in which 13 patients with PPS maculopathy were followed prospectively with multimodal assessments of retinal structure and function. Functional testing endpoints include: BCVA, microperimetry (MP) mean and percent reduced thresholds.

Structural endpoints included: subfoveal choroidal thickness (SFCT), central subfield retinal thickness (CST), and geographic atrophy area. Baseline and Year 1 outcomes were compared.

On study results, Dr. Jain reported: “We observed that patients stopped PPS use a median of 9.9 months prior to baseline.

Median change in BCVA during the study period was -3 letters (IQR -4.75 – 1.5) We also found significant reductions in microperimetry CST and SFCT over the 1 year period”.

According to Dr. Jain, this study demonstrates continued evolution of PPS maculopathy even after drug cessation.

“Geographic atrophy enlarged in all eyes that manifested atrophy at baseline and new atrophy can start after drug cessation. Retina specialists screening patients for PPS maculopathy should be aware of the potential long term visual impact of this condition,” he said.

“We evaluated the suprachoroidal space as an efficient delivery pathway for a variety of small molecule suspensions.

Using a single bilateral injection to rabbits, we explored the suprachoroidal delivery of various small molecule therapeutic agents,” noted Dr. Major.

Agents tested included suspensions of tyrosine kinase inhibitor axitinib, complement factor D inhibitor A01017, and plasma kallikrein inhibitor BCX4161.

Drug levels were assessed in retinal pigment epithelium (RPE)/choroid/sclera (RCS), retina, vitreous humor, aqueous humor and plasma over a period of 3 months.

“Suprachoroidal delivery of small molecule suspensions of axitinib, A01017, and BCX4161 demonstrated greater concentration of those agents in the posterior segment tissues than in anterior segment tissues, vitreous humor or plasma. At 3 months, drug depot levels in the RCS remained above IC50 levels,” he reported.

Based on these results, Dr. Major concluded that suprachoroidal delivery of small molecule suspensions demonstrate prolonged therapeutic levels with potential for sustained release and high bioavailability, while showing compartmentalization to ocular posterior tissues.

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14

10 October 2021 | Issue #2

MIGS and Trabeculectomy Evidence, Costs and Options

by Sam McCommon

M

inimally-invasive glaucoma surgery — MIGS — has been a hot topic lately, so one could fully expect significant discussion of the topic at the 39th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2021). They didn’t disappoint, as Day 2 of the hybrid conference hosted a symposium on evidence-based approaches to MIGS. Glaucoma treatments of all forms abound, with trabeculectomy still ruling the roost. As one panelist noted, “You shouldn’t throw away your shoes until you have a new pair.” Translated, that means that before we move on from trabeculectomy and toward other glaucoma treatments, we should make sure these other treatments are effective, safe and cost-effective.

MIGS vs trabeculectomy: An evidence-based comparison Dr. Henny J. Beckers, from the University Eye Clinic in Maastricht, The Netherlands, led off the discussion by comparing various MIGS treatments to trabeculectomy. As she pointed

MIGS as well, as many ophthalmologists are aware. MIGS treatments offer less risk than blebforming procedures, Dr. Beckers noted, but they’re often less effective.

out, according to the 2020 guidelines of the European Glaucoma Society, trabeculectomy is still the first choice for open-angle glaucoma (OAG). Other options, like tube shunts, less invasive filtering surgery, bleb-less surgery like canaloplasty, and MIGS are available.

These options may be valuable depending on the costs involved, their availability, and the surgeon’s preference.

There are plenty of options within

But why use MIGS in the first place?

There are quite a few potential reasons, Dr. Beckers pointed out. They’re valuable if used earlier in the treatment algorithm, and are valuable for those with an intolerance to IOP-lowering medications.

They’re also valuable for improving quality of life problems and managing medical adherence, and can be combined with cataract surgery and future glaucoma filtering surgeries.

Bleb-forming procedures, on the other hand, don’t combine well with cataract surgery, so cataract surgery may need to happen first.

There are lots of MIGS available, with IOP-lowering power from 15-50%. So, at least surgeons have many options available. Subconjunctival procedures are the most promising, but require

CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments

mitomycin-C to be successful. They may provide a less invasive alternative to trabeculectomy.

“MIGS treatments offer less risk than blebforming procedures, Dr. Beckers noted, but they’re often less effective.”

The XEN stent (Allergan, an AbbVie company, Dublin, Ireland) has been extensively studied and has shown robust and long-lasting reductions in IOP; however, up to 60% of patients required needling to get pressure under control, and 10-20% of patients needed reoperations. Evidence is emerging on the Preserflo MicroShunt (Santen, Osaka, Japan) with, again, robust IOP reduction — and less needling. Still, reoperation is required in about 10% of cases.

Dr. Beckers compared XEN to Preserflo in her own clinic, with similar success rates.

Both procedures have mild and mostly self-limiting complications, mostly limited to hypotony. She also noted that the XEN stent can curl because it’s soft material, whereas the MicroShunt does not.

One study underway compares XEN with trabeculectomy, which we’ll keep our eyes on for results. Another

study comparing the MicroShunt to trabeculectomy shows that trab achieves lower IOP over time, though the MicroShunt lowers IOP faster.

Additionally, the trab group required fewer medications than the MIGS group — 51.9% versus 90.3%, respectively.

There were also more IOP-related adverse events with the MicroShunt than trabs, as well. However, the MicroShunt did demonstrate a favorable safety profile, as well as a more predictable postoperative course.

Dr. Becker’s conclusions?

Trabeculectomy remains the gold standard procedure for OAG. MIGS has a lower IOP-lowering potential. Meanwhile, subconjunctival shunts with mitomycin-C lead to sustained IOP reduction. Keep your eye on this space for further developments.

Trabeculectomy vs subconjunctival draining devices: Expensive trabeculectomy?

Cost is always a question in the medical world, and the question of costs was raised by Dr. Simonetta Morselli, director of the ophthalmic unit at the San Bassiano Hospital in Italy. Rather than simply considering monetary cost, Dr. Morselli also considered the biological cost — which is a pretty clever way of considering the situation.

Trabeculectomy is still consistently used to control IOP because it’s an easy and — crucially, for this discussion — cheap procedure. However, it’s not without its complications, from early to late, including bleb scarring and cataract.

Patients must be followed up on for a long period of time after trabeculectomy.

In that regard, trabeculectomy’s costs mount in the postoperative phase.

The XEN stent also has its share of postoperative complications, but they’re fewer than trabeculectomy. As Dr. Morselli explained, XEN is more expensive, but it has fewer postoperative side effects.

“Trabeculectomy is still consistently used to control IOP because it’s an easy and — crucially, for this discussion — cheap procedure.

However, it’s not without its complications, from early to late, including bleb scarring and cataract.”

However, there are biological costs to consider as well. Trabeculectomy allows for further surgeries following the operation, but Dr. Morselli argued that it’s expensive in terms of biological costs.

Conversely, filtering devices are more expensive in terms of money, but cheaper in terms of biological costs. There’s less hospitalization required, there are fewer postoperative complications, and more options for enhancement post-surgery.

Options are a good thing, right?

There are lots of MIGS available, with IOP-lowering power from 15-50%. So, at least surgeons have many options available.

We should all be happy that options abound for glaucoma treatments these days, and we can expect more data to be released comparing MIGS to trabeculectomy in the near future.

In the meantime, taking a patient’s individual needs into account is crucial as there’s no one-size-fits-all treatment for glaucoma, since it’s a multifactorial and individualized disease. Kudos to the presenters and to the researchers for bringing us this data and all these new treatments.

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10 October 2021 | Issue #2

Giving Recognition Where it’s Due ASRS 2020 Award Winners

by Nick Eustice

B

ecause of the effects of COVID-19, last year’s ASRS Scientific Meeting was unlike any other year in its history. One significant difference was that the mostly online format made an award’s ceremony impossible. For this reason, two ceremonies will be held at this year’s conference, with Day 1 presenting the 2020 award recipients, and another to follow on Day 2 for 2021.

The Gertrude D. Pryon Award The first award presented was the Gertrude D. Pryon Award. This award is given annually by the Retina Research Foundation, in recognition of “outstanding vision scientists whose work contributes to knowledge about vitreoretinal disease.”

The 2020 recipient, Dr. Mark Humayun MD, PhD, is a major name in the field of retina research, and a past ASRS president. Having already received the National Medal of Technology and Innovation — the United States Government’s highest honor for technological achievement — Dr. Humayun is widely-known for his work developing the first FDA-approved artificial retina, the Argus II. As a prominent inventor in the biomedical

field, Dr. Humayun is a member of many esteemed engineering and medical societies, and the Pryon Award is one of many awards which he has received in recognition of his work in the field.

His lecture, entitled Advanced Retinal Implants, concerned itself with new developments being made in this exciting field.

“Any complex chronic diseases, such as retinal diseases, require a multi-faceted approach,” began Dr. Humayun. These facets include pharmacology, gene therapy, cell-based therapy, surgery, and of course, the subject of his talk: implants.

“We sometimes forget that the eye, as an organ, gets the most implants of anywhere in the body,” he explained.

While most of these implants take place in the front of the eye, Dr. Humayun asks that we take a page from this book and apply it to the retina.

To make use of a thoroughly worn-out cliché, when talking about progress in retinal restoration, a picture can often be worth a thousand words. Dr. Humayun showed photos taken from studies 10 years apart, from early Argus II results in 2008 allowing a patient with vision loss to see a single letter taking up an entire screen, to being able to navigate multiple

rows of an eye chart 10 years later. These were pretty striking results.

But the bigger news was right around the corner. While these earlier results were achieved with the 60-electrode Argus II, a new epiretinal prosthesis, the IMEI 256, makes use of more than four times the electrodes in an implant of comparable size. This next-generation prosthesis is also implanted in only one quadrant, while the Argus II required implantation in two.

The video results which he showed moments later were quite impressive.

A patient implanted with the IMEI 256 was shown sitting in front of a computer screen. Looking at the screen, the subject was able to identify a standard-sized character, far smaller than the previous charts from 2018. The character was replaced with another, and then another, and the patient was able to identify the characters both rapidly and confidently.

It is clear that these next-generation implants represent a great leap forward.

CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments

Eugene de Juan in the early ‘90s. This innovative program produced a plethora of useful patents, among which was the early concept of PDS.

The Founders Award The next award presented was the Founders Award, presented annually by the ASRS in recognition of major contributions in vitreoretinal surgery, treatment and patient care. The 2020 award was presented to Dr. Carl Regillo, another very prominent name in virtually all areas of retinal research.

Dr. Regillo received the award specifically for his foundational work in an area of considerable buzz at the moment: that of the Port Delivery System (PDS). Dr. Regillo presented a historical lecture on this topic, describing the different stages of development and the obstacles which have been overcome in bringing this technology to its present stage, ever nearer widespread approval and release.

The advantages of the PDS are well known at this point. An implanted device which regularly delivers intravitreal doses of medications has wide-reaching applications, and clear benefits for doctors and patients. More consistent release of medication, the need for fewer office visits, and the less discomfort for patients make this device a very attractive prospect for those suffering from AMD, as well as other conditions requiring frequent care. Over 93% of study subjects indicate a preference for PDS over traditional injections.

While we get nearer to public application of PDS with each passing day, Dr. Regillo tells us about the long “journey” which this invention has been on for almost 30 years. PDS began life in the Matlab program at Johns Hopkins, led by Dr.

It was not until 2010, however, when the anti-VEGF era began, that the development of the system began to truly take shape. It was then that clinical trials revealed that only a relatively small, but regular dose of ranibizumab was necessary to show positive results. With this discovery of a practical application for PDS, research began moving into more practical clinical phases.

Many advances took place during several phases of research. Specialized equipment had to be developed, including the implant itself, as well as the unique refill exchange needle.

Additionally, surgeons needed to be trained in implanting the device. Insertion of a permanent implant such as this was (and still is) a very unique procedure to introduce.

The development period was not without setbacks. Early trials resulted in a 50% instance of hemorrhaging in patients when the first devices were implanted, which led to redevelopment of insertion of the surgical procedure. Later on, dislocations of the PDS occurred in patients, which revealed errors in the length of the incision in the initial insertion.

Once surgically corrected, these issues ceased to be major problems, and the program has moved forward with very positive results, up to and including the present FDA approval process.

Congratulations to the winners Also honored at the 2020 ceremony were several other esteemed retina professionals. Dr. Caroline Baumal received the Crystal Apple Award in recognition of her tireless work in the development of new retinal specialists.

The Packo Service Award was presented to the 3 founders of the ASRS: Dr. Jerald Bovino, Dr. Roy Levit and Dr. Allen Verne, in recognition of their many years of service to the society. Dr. Charles Wykoff received the Young Investigators Award in recognition of his many significant achievements made by a doctor under the age of 45. Finally, Dr. Jerry Shields was presented with the Retina Hall of Fame’s Lifetime Achievement Award for his years of work in research dedicated to the management of ocular tumors.

Congratulations to all of 2020’s award recipients. We’re very much looking forward to the presentation of this year’s awards, which because of our unusual schedule means waiting not a whole year, but just until tomorrow!

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18

10 October 2021 | Issue #2

The latest portable PXL Systems made in Switzerland by PESCHKE Trade The latest portable PXL Systems made in Switzerland by PESCHKE Trade

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These fully portable and ergonomically designed systems come with an adjustable table mount and a sturdy transport case.

These are open systems, i.e. no activation cards, no barcodes, no treatment fees, and the treatment Our PXL systems contain a built-in communication technology, allowing to communicate across systems protocols are included. are considered being the best high-end portable and user-friendly devices on the market according to (i.e. exportThey of generated treatment reports).

Swiss, European and global users. No other portable system comes with an eye tracker and custom treatment mode.

CXL – The Experience Our PXL systems contain a built-in communication technology, allowing to communicate across systems (i.e. export of generated treatment reports).

In recent years corneal cross-linking has become the standard procedure for treating patients with progressive

keratoconus and other ectatic corneal diseases because of its effectiveness and lack of serious side effects. A large CXL – The Experience number of major clinical studies has proven the effectiveness of CXL and the lack of serious side effects. More than 85% of the eyes treated with CXL showed a significant increase in BCVA. In recent years corneal cross-linking has become the standard procedure for treating patients with progressive keratoconus and other ectatic corneal treatment diseases because of its effectiveness and lack serious sidedisorders effects. A(such largeas CXL is the only effective non-invasive to stop progressive Keratoconus andof other ectatic number of major clinical studies has proven the effectiveness of CXL and the lack of serious side effects.

More than PMD and iatrogenic ectasia) and has a regularisation effect on corneal topography.

85% of the eyes treated with CXL showed a significant increase in BCVA. In addition to its role in treating ectatic corneal diseases, CXL has an established place in the management of CXL is the keratitis. only effective non-invasive treatment tofor stop and other ectatic disorders (suchand as infectious UV light has long been known itsprogressive ability to killKeratoconus different micro-organisms (such as bacterial PMD and iatrogenic ectasia) and has a regularisation effect on corneal topography. fungal). Since keratitis in humans is an important cause of blindness, and antibiotic resistance is an increasing problem worldwide, CXL proves to be an extremely valuable possibility to manage the condition with a satisfactory In addition to its role in treating ectatic corneal diseases, CXL has an established place in the management of Outcome. infectious keratitis. UV light has long been known for its ability to kill different micro-organisms (such as bacterial and fungal). Since keratitis in humans is an important cause of blindness, and antibiotic resistance is an increasing problem worldwide, CXL proves to be an extremely valuable possibility to manage the condition with a satisfactory Outcome.

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