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Heidelberg Engineering: Enhancing the Patient Journey

Clinical

1rem

DSAEK will soon replace conventional PK surgery for the treatment of endothelial decompensation

Stripping corneal surgery of complications

I was delighted with the results. My patient's subsequent visits at 12 and 18 months post surgery were equally encouraging as endothelial cell count and corrected vision remained unchanged

Is there hope for patients unable to receive a donor cornea?

This procedure has distinct advantages over conventional surgery for keratoconus and may eventually supersede it

New techniques for the surgical treatment of keratoconus

Remaining questions about DED pertain to geographic considerations, prevalence measures for DED in children and the design of future studies to determine risk factors in patients under 40

Interdisciplinary report illuminates demographic, systemic health factors of dry eye disease

Cabozantinib, a vascular endothelial growth factor receptor tyrosine kinase inhibitor, has previously been associated with hepatic and dermatologic adverse effects

Case report examines corneal perforation associated with tyrosine kinase inhibitor

Research findings from the multicentre clinical study were presented at the European Society of Ophthalmology (SOE) meeting in Lisbon, Portugal

New dry eye disease study compares two preservative-free artificial tear drops

The investigational device, ETX-4143, was the focus of a study involving 31 patients with COSP in Australia

EyeCool Therapeutics announces results from pilot study of novel chronic ocular surface pain treatment

Ultraviolet light’s potential in ocular care extends beyond structural reinforcement to antimicrobial applications, especially for microbial keratitis

The future of microbial keratitis treatment is bright

Rayaz Malik, MBChB, PhD, a professor of medicine at Weill Cornell Medicine - Qatar, spoke with Ophthalmology Times Europe about his presentation. It's titled "An eye on neurodegenerative diseases: Challenging the dogma" at the International SPECTRALIS Sympsoium

The 21st International SPECTRALIS Symposium (ISS) brought industry leaders to Heidelberg, Germany, in mid-June. During the two-day meeting, a scientific programme covered topics including oculomics, biomarkers, neurodegeneration and more.

Rayaz Malik, MBChB, PhD, a professor of medicine at Weill Cornell Medicine Qatar, sat down for an interview with 

 He provided background on his presentation, titled "An eye on neurodegenerative diseases: Challenging the dogma." 

, Prof Malik demonstrated why the cornea is a particularly viable source of biomarkers. In this video, he talks about the origins of artificial intelligence (AI) and corneal confocal microscopy (CCM), the applicability of AI in analysing corneal images and what to expect from the next decade of ocular biomarkers in neurodegeneration.

Videos

In the second of two video interviews from the International SPECTRALIS Symposium, Prof Malik emphasises the importance of corneal imaging

Rayaz Malik, MBChB, PhD: The bold future of imaging lies in the anterior segment

Rayaz Malik, MBChB, PhD, shares his presentation, titled An eye on neurodegenerative diseases: Challenging the dogma, at this year's International SPECTRALIS Symposium

During the second weekend of June, Heidelberg Engineering will open its new Heidelberg Congress Center for the 21st International SPECTRALIS Symposium (ISS). The meeting in Heidelberg, Germany, begins on Friday, 13 June with a scientific programme including topics like oculomics, age-related macular degeneration and distributed care models.

Rayaz Malik, MBChB, PhD, a professor of medicine at Weill Cornell Medicine - Qatar, spoke with 

 about his presentation. It's titled "An eye on neurodegenerative diseases: Challenging the dogma." During his lecture, Prof Malik demonstrated the potential of corneal confocal microscopy as an effective diagnostic tool for patients with markers of neurodegenerative disease.

In the first of two video interviews, Prof Malik explained why the cornea is a particularly viable source of biomarkers and described the unique anatomical features of the anterior segment which are the focus of his research. Watch the full video to hear what he shared at the ISS.

Prof Malik shared his presentation, titled "An eye on neurodegenerative diseases:
Challenging the dogma," at this year's International SPECTRALIS Symposium 

The cornea is the unsung hero of diagnosing neurodegeneration, says Rayaz Malik, MBChB, PhD

Elizabeth Cohen, MD, discusses the Zoster Eye Disease study at the 2024 AAO meeting

At this year's American Academy of Ophthalmology congress, Elizabeth Cohen, MD, discussed recent findings from the Zoster Eye Disease study. Here are her highlights from the research, which focused on suppressive valacyclovir use and results for patients with keratitis and iritis.

Editor's note: The below transcript has been lightly edited for clarity.

 My name is Elizabeth Cohen, and I am Professor and Vice Chair of the Department of Ophthalmology at NYU Grossman School of Medicine, NYU Langone Health. So the Zoster Eye Disease study has just come out with its results, and the main takeaways are that if we treat patients or study participants who have shingles in the eye and have eye involvement, and we put them on a low dose of valacyclovir, 1000 milligrams daily for a year, we will reduce the likelihood of flare ups of their keratitis or iritis, statistically significant at 18 months. In addition, at both 12 and 18 months, we prevent people from having multiple flare ups of keratitis or iritis, which is very important, because those people can go on to chronic and recurrent disease and loss of vision. 

The other take home point is that we look to see the benefit for this treatment with regard to post-herpetic neuralgia of chronic pain syndrome, as well as pain-related shingles, and we found very significantly that treatment with low dose of valacyclovir reduces the need for neuropathic pain medicine, which are very poorly tolerated. They make people tired, and valacyclovir is much better tolerated. There also were other benefits with regard to the amount of pain, the duration of pain, and the prevalence of postherpetic neurology in some groups, but overall, the biggest benefit with regard to pain was reducing the need for these pain medicines. So we really hope that ophthalmologists will lead the way and that their doctors will evaluate the use of suppressive valacyclovir to reduce pain related to Zoster in other locations. 

...This study was modeled after the Herpetic Eye Disease Study, [an] acyclovir prevention trial that looked at low-dose acyclovir for reducing recurrences of herpes simplex virus disease, and we use the same approach to study herpes zoster caused by a different herpes virus, the varicella zoster virus. And in the head study on HSV disease, there was benefit at 12 months, but not at 18 months. And here we saw a greater benefit at 18 months, both regarding the eye as well as regarding the pain. So that was a little surprising, in how much—the difference in benefit for the eye wasn't that great, but enough of a difference to be between statistically significant and not significantly significant. So we still think there's benefit, period, for the eye manifestations, with regard to the post herpetic neuralgia and the pain, 12 and 18 months were equal endpoints, whereas for the eye problem, 12 months was the primary endpoint. So with regard to the pain, I think the greater benefit at 18 months may be because it takes nerves that are injured and inflamed time to heal. And when I'm asking myself, "Why do we have greater benefit with the eye disease," the benefit wasn't that much greater, but it also we had a lot of a number of early endpoints around 3 months into the study, and it may take more time for the suppressive treatment to kick in its benefits.

Research indicates suppressive valacyclovir could help patients avoid keratitis and iritis flare-ups

AAO 2024: Main takeaways from the Zoster Eye Disease study

ARVO 2024: Andrew D. Pucker, OD, PhD on measuring meibomian gland morphology with increased accuracy

At this year's ARVO meeting, the Eye Care Network spoke with Andrew D. Pucker, OD, PhD, executive director of clinical and medical science at Lexitas Pharma Services Inc. He shared key takeaways from a recent study  regarding meibomobian gland morphology, comparing data measured with a Visante OCT versus an OCULUS Keratograph 5M. The study was also published in 

: Hello, my name is Andrew Pucker. I am the executive director of clinical and medical sciences at Lexitas Pharma services, and today I'm excited to talk about my recent paper that was published in 

In this study, what we did was we compared people who were analysed with a Visante OCT, which has a long wavelength of light, which is around 310 nanometers, to people who were analysed with an OCULUS Keratograph 5M, which has an 880 nanometer wavelength. So with these two instruments, what we did is we looked at their eyelids, we looked at their meibomian gland morphology, and what we found was that with the OCT, they had longer eyelid glands compared to the chronograph.

So why is that important? So about 3 or 4 years ago, I was reading in the literature, and I found that post-treatment, the meibomian glands got longer, which doesn't really make sense. Typically, we think of a gland once it's gone. It's atrophied. You can't get it back. But what happened is, there's several studies that found it was longer post-treatment. So what I think my data suggests is that on OCT, you can just image deeper into the eyelid and see these glands that are always there that are probably being missed with the Keratograph. So post-treatment, what might be happening is that the glands are becoming healthier, thicker, and become more visible on meibography, which is why there's being shown as longer post-treatments. So really, I think the glands are there. They're just not healthy. And what we can do now is use this technology to hopefully better design trials to see how treatment changes occur over time.

So the next step is, I think, to potentially optimise our existing meibographers. So the Keratograph 5M is just one example. That's what we used, but it has this shorter wavelength than the Vistante OCT, which is not used typically for analyzing the meibomian glands. So what we can potentially do is have manufacturers take this information, optimise the wavelengths, so maybe you're catching all the glands instead of just more the superficial gland.

At the 2024 ARVO meeting, Andrew D. Pucker, OD, PhD, presented a paper on measuring meibomian gland morphology

ARVO 2024: Trial design and increased accuracy of meibomian gland morphology measurements

Elias Kahan on his poster, "Contact Specular Microscopy Reliably Images the Same Endothelial Location"

At this year's ARVO meeting, the Eye Care Network spoke with Elias Kahan, MD, a clinical research fellow in the Department of Ophthalmology at the New York University Grossman School of Medicine. He spoke about his poster on contact specular microscopy and its implications for future corneal endothelial research.

Hi, my name is Elias Kahan. I'm a clinical research fellow and incoming PGY1 resident at NYU. I'm here to talk about my poster, "Contact specular microscopy reliably images the same location of the corneal epithelium." In my poster, we discuss the use of a wide-field contact slit scanning specular microscope recently developed by Konan Medical. And what makes this device unique is that it allows us to image the far periphery of the endothelium. So, conventional, noncontact devices image the central and paracentral, so a few millimeters from the central, of the endothelium. This device allows the imaging all the way to the limbus in all directions. 

In the course of imaging a number of individuals, we found that applanating the cornea, applying pressure, creates physical distortions in the endothelium. You can think of them as wrinkles, or, as we call them, undulations. Over the course of imaging, we found that, as we moved the lens across the endothelium, these, these distortions, these anatomic landmarks, were static, and they didn't change. So we wanted to understand whether we could use them to map the endothelium and return to the same location over time. So we created a pilot study where we imaged 20 eyes, and we had them come back a week or 2 later, and we tried to identify the same location that we found in the first visit. So out of the hundreds of thousands of cells in the endothelium, we were able to pinpoint individual, unique cells weeks apart using these physical distortions, or as we call them, anatomic landmarks, as a map. So we imaged about twenty individuals. In fifteen of them, we were able to find the same exact cell. We analyzed the morphologic metrics of the endothelium and found very high intraclass correlation coefficients, which made us feel confident that this was repeatable. 

Looking long-term, we believe that we could use this to better track the progression and the impact of medical or surgical interventions in patients with corneal disease. So in patients with Fuchs, for example, we can't really study the far periphery using conventional microscopes. So using this device, we can image the far periphery and understand behavior of cells near the limbus. And, using this methodology, we could identify individual cells and then track their progression over time. So, if a patient were to receive a ROCK [Rho Kinase] inhibitor or Descemet stripping only, we would [be] able to use, theoretically, use this methodology to see how those cells behave. As of now, we've only imaged in healthy individuals, but the next step of this project is to increase our sample size in healthy individuals and image patients with corneal disease to validate it and hopefully integrate it moving forward.

Elias Kahan speaks about his ARVO poster, "Contact specular microscopy reliably images the same location of the corneal epithelium"

ARVO 2024: Reliability of contact specular microscopy in the corneal endothelium

Neda Gioia, OD, sat down to discuss a poster from this year's ARVO meeting held in Seattle, Washington

Ahead of this year's ARVO meeting in Seattle, Washington, the Eye Care Network met with Neda Gioia, OD. She discussed a poster presentation from the meeting, focusing on a multi-ingredient oral supplement for dry eye symptoms and tear volume.

- This transcript has been edited for clarity.

I'm David Hutton of Ophthalmology Times. The Association for Research in Vision and Ophthalmology is holding its annual meeting in Seattle. Dr Neda Gioia is joining me today to discuss her presentation at the meeting, titled "Clinical evaluation of a multi-ingredient oral supplement on dry eye symptoms and tear volume." Thank you so much for being here. Tell us about your presentation.

Thank you so much, David, for having me here today. It's very exciting to be presenting at ARVO for these posters and talking about this very unique new oral supplement that is going to be in the hands of our doctors and patients soon.

So the posters, really there's two posters, but I'm going to talk about 1 more extensively, and that's the one about the multi-ingredient oral supplement on dry eye symptoms and tear volume. So the poster reflects a need right now, in terms of our dry eye toolbox and that's because over 150 million Americans are suffering from dry eye syndrome, if not more, and the incidence of this is increasing globally, not just in the US. And we can connect this to many different things: lifestyle factors, general health factors, digital use, etc. So we really need more expansion in terms of our options for our patients and it's nice to have something that is a prospective, randomised, double-blind, placebo-controlled study that features this oral supplementation as used to improve dry eye symptomology and improve dry eye tear volume.

So speaking about the poster, the objective is really to test the efficacy and the safety of this novel supplement. Now, just to kind of backtrack, what is the supplement made of? It's a proprietary blend of 20 milligrams of lutein, 4 milligrams of zeaxanthin isomers, alongside curcuminoids 200 milligrams, and vitamin D3 at 600 IUs, and this proprietary blend is tested against a placebo of 600 milligrams of soybean oil. So the eligibility criteria in these patients are roughly aged 18 to 65 and it's a four-center test in the United States, with 116 subjects roughly split evenly between the placebo and the supplement group of neutral tears. And ultimately, the way that they accepted, the investigators, these subjects into the dry eye category is they assessed the OSDI scores, and a score of between 12 to 40, alongside a Schirmer's tear volume tests, which was assessed at less than an equal to 10 millimeters by a licensed optometrist really put everyone into that eligibility category to clinically say that these patients had mild to moderate dry eye. Now, these, the subjects were tested baseline and then at day 14, day 28, and day 56.

The primary endpoint of the OSDI as well as the Schirmer's tests were pretty remarkable. The OSDI scores at day 14 start to show statistically significant improvement, which is really, really amazing, knowing how nutraceuticals work, and that's going back to the formulation most likely and the bioavailability of that formulation. And that kept improving into day 56. Alongside that the tear volume also improved around day 28, again statistically significant. Now there were secondary endpoints that all showed improvement except for 1 which was not plus or minus, it was just the same and that was the artificial tear use. And those types of tests include MMP scores, TBUT scores, corneal and conjunctival staining, SPEED scores, again another subjective point for the test subjects. And these all showed improvement as well, statistically significant around that day 56. So in 2 months, we saw so many points of improvement in tear quality, tear volume. And even more importantly, the patient's report, right, because dry eye's also something alongside quality of life. So we see those quality of life scores improve.

And really the bottom line was this NutriTears formulation, this LCD formulation that we saw tested by these investigators, it really improved dry symptom relief, again, seen as little as 2 to 4 weeks. And the clinical data just really just shows the efficacy and the safety of this proprietary blend of the lutein, zeaxanthin isomers, curcumin, and vitamin D3 as a daily supplement to help with the signs and symptoms of dry eye. So having this therapeutic potential in a supplement form to help address the signs and symptoms of dry eyes in all these patients that we're seeing is going to really give us a lot of confidence to help add to our toolbox of treatments.

Now, the second poster emphasises how the India study, which also was done a few years prior to the USA study, showed really similar results. Now the subject number was slightly smaller. Actually, if anything, the artificial tears usage, which seemed to be used less, as early as day 14 as well, again with statistical significance. It was a 1 center study, but in conjunction with the USA study, I think we really have 2 nice, solidified ways to show that this new novel, multi-ingredient oral supplement can help with dry eye symptoms and tear volume.

Well, what's wonderful is that this proprietary blend has also been investigated to come straight to the shelves, to basically be applicable to doctors to help recommend and also patients to basically use to help improve their dry symptomology. So, long story short, it's going to be accessible, most likely in the second half of this year.

At this year's ARVO meeting, Neda Gioia, OD, discussed the increasing patient burden of dry eye disease

ARVO 2024: Exploring multi-ingredient oral supplements for alleviating symptoms of dry eye disease

Eric Donnenfeld, MD, sat down to discuss his presentation ahead of this year's ARVO meeting 

Eric Donnenfeld, MD, a corneal, cataract and refractive surgeon at Ophthalmic Consultants of Connecticut, discussed his research with the Eye Care Network ahead of this year's Association for Research in Vision and Ophthalmology (ARVO) meeting. His presentations on the novel new artificial tear, Blink Triple Care, focus on its efficacy in a non-controlled trial, as well as comparison to the Classic Blink.

 The Association for Research in Vision and Ophthalmology is holding its annual meeting in Seattle. At that meeting, Dr Eric Donnenfeld presented "Clinical evaluation of a novel lipid-containing eye drop." Thank you so much for joining us today. Tell us about your presentation.

Hi, I'm Eric Donnenfeld, and I'd like to tell you about two different presentations that we're doing here at ARVO. These involve a novel new artificial tear called Blink Triple Care. Blink Triple Care is the first and only artificial tear that contains not only polyethylene glycolate as a lubricant, but also contains hyaluronic acid and has a nanoemulsion of lipid. It's transiently preserved. 

The first study just looked at the efficacy of this medication in a non-controlled trial, in which 77 subjects were enrolled, and of these, 75 completed the trial. We looked at baseline comfort and quality of vision, and we saw a statistically significant improvement in quality of vision at 7 days and again at 3 months later. Tear breakup time, from a breakup, was 8.8 seconds originally and 10.1 seconds on the third visit. The slit lamp findings showed a significant reduction in corneal staining. 

We follow this up with a second trial in which we compared Blink Triple Care to the Classic Blink, which was the first hyaluronic acid-based tear used in the United States. What we found was a non-inferiority to Blink. What we looked at in this study was 158 participants enrolled, 130 completed the trial. We compared overall comfort scores from baseline to the 30-day follow-up. We show that this novel lipid-containing eye drop was similar to the Blink, but was actually better in this non-inferiority comparison, looking at ocular comfort. There were no significant adverse events in the trial, and basically, the take home message from these two different studies are that this novel, new Blink Triple Care, which combines hyaluronic acid with nanotechnology lipid, is a very effective therapy in the management of dry eye disease. Thank you very much.

Eric Donnenfeld, MD, discusses the clinical evaluation of Blink Triple Care artificial tears ahead of the 2024 ARVO meeting

ARVO 2024: Evaluating a lipid-containing eye drop for dry eye disease

John D Sheppard, MD, MSc, FACs, discusses the GOBI and MOJAVE trials

ARVO 2024: Post-hoc analysis of GOBI and MOJAVE trials for perfluorohexyloctane

Ahead of this year's ARVO meeting in Seattle, Washington, the Eye Care Network sat down with John Sheppard, MD, MSc, FACs, who is the president of Virginia Eye Consultants. He discussed post-hoc analysis of two FDA registration trials for perfluorohexyloctane, GOBI and MOJAVE, and what the results mean for practitioners in a real-world clinical setting.

- This transcript has been lightly edited for clarity.

 The Association for Research in Vision and Ophthalmology is holding its annual meeting in Seattle. Dr John Sheppard is joining us today to discuss his presentation at the meeting. Thanks for being here. Tell us about your presentation.

: I'm here in Norfolk, Virginia, and very happy to share our data from a post-hoc analysis of two FDA registration trials for perfluorohexyloctane, or PFHO, an ophthalmic solution for patients with dry eye disease and meibomian gland dysfunction. The studies were called GOBI and MOJAVE. They were sponsored by both Novaliq of Heidelberg [Germany] and Bausch and Lomb in the United States. These were prospective, randomised, multicentre clinical trials, and they looked at four-time-a-day drops compared to a placebo of hypotonic saline. Now, the drops don't have an API, or active pharmaceutical ingredient. Because the drops are the vehicle and the vehicle are the drops, it's 100% PFHO. This is a unique, semi-fluorinated alkane. It's used in retinal detachment surgery and blood product preservation and over large reservoirs of water coating the surface to prevent evaporation. Because of its biochemistry, these drops have a size of only 11 microliters. So there's no slop or overflow, and they have at least a 6-hour surface adhesion time to preserve evaporative tear loss to allow the osmolarity and the inflammatory processes on the surface of the eye to normalise, creating homeostasis, as all of the drops produced and retained and all of the tears produced by the patient are maximised. 

So in this trial, we looked of course at the registration data, and this met both sign and symptom endpoints in both trials, truly remarkable. In the post-hoc analysis that we're looking at at ARVO, we looked at baseline MGD score divided that into two groups: moderate and mild. We looked at the baseline total corneal fluorescein staining score and divided that into mild and moderate down the middle. We finally looked at the baseline, Schirmer's 1 test, and divided that below 10 millimeters and equal to or above 10 millimeters, that is moderate and mild dry eye. We looked at the forest plot, and we looked at responder rate analysis. We found, from top to bottom, both the mild and the moderate of all three groups responded equally well statistically significantly to the medication compared to the vehicle. 

This tells us that the prescribing eye care provider can choose a wide variety of dry eye patients and expect excellent results as we saw in the clinical trials. This gives me confidence that these analyses of pooled data from the two Phase 3 randomised control trials show that PFHO is efficacious in the treatment of signs and symptoms of dry eye disease in patients with a wide variety of clinical presentations. Thank you.

John Sheppard, MD, MSc, FACs, discusses the unique biochemical traits of perfluorohexyloctane for eye dry disease and meibomian gland dysfunction

ARVO 2024: Dry eye patient selection following post-hoc analysis of GOBI and MOJAVE trials

ASCRS 2024: What advancements in Light Adjustable Lens technology mean for clinicians and patients

 about her presentation on the Light Adjustable Lens during an ASCRS symposia on IOL calculations.

- The following transcript has been lightly edited for clarity.

 Hi, my name is Neda Nikpoor. I am a private practice doctor—a cornea, cataract, and refractive surgeon in Honolulu, Hawaii. I have the pleasure of giving a talk in the IOL calculation section on Light Adjustable Lenses. So, how easy of a talk could I have gotten because honestly everything else in that session is all about how to do all these complex calculations, all the formulas. And my part is simple, because with the Light Adjustable Lens [RxSight Inc.], you literally just need to be within two diopters of sphere and three diopters of cylinder, and you can hit your target. But obviously, there's a little bit more to it than that.

So some of the data that's actually really pretty powerful around Light Adjustable Lens is that in the phase 4 data, well over 90% of eyes were within a half diopter for mean residual spherical equivalent, as well as residual astigmatism. And that really low amount of residual refractive error leads to better visual outcomes. And so patients had high rates close to 90% of seeing uncorrected 20/20 at distance, and over 90% of patients binocularly would see J1 or better at near.

The other thing that's really exciting with Light Adjustable Lens technology is we now have LAL+ [Light Adjustable Lens+] and LAL+ as most of you know has a little bit more extended depth of focus [EDOF] than the original LAL, which also has some EDOF built into it. And that translates into better range of vision for patients.

Now the really nice thing is we always say there's no free lunch. But honestly with this it kind of seems like there is. The only sacrifice that we've seen in distance vision across the study was 1 letter, and the improvement in near was significant. So the monocular distance corrected near mean in patients is 20/40, at near, which is really quite incredible for a monofocal lens that has some EDOF. The rates of glare, halo, dysphotopsia, or anything like that are still very, very, very low and no different from the traditional LAL.

So you can rest assured that with this lens, honestly, it seems based on the data that patients do get excellent distance and near vision and have great binocular vision and over 80% of patients in the study actually chose blended vision. So that makes IOL calculation a lot easier I think.

Dr Neda Nikpoor discusses Light Adjustable Lenses and the implications for clinicians at ASCRS 2024

ASCRS 2024: Transforming how we think about IOL calculation with Light Adjustable Lens technology

The global vice president discussed upcoming trials and commercialization for the endothelial cell therapy

ASCRS 2024: Eris Jordan, OD, talks about the near future of Aurion Biotech

At this year's ASCRS meeting in Boston, Massachusetts, Ophthalmology Times Europe caught up with Eris Jordan, OD. She talked about the big plans the Boston-based startup has for the year ahead. Watch the full video to find out what's in store for the company and its novel cell therapy in Japan, Canada and the United States in 2024.

Hi, I'm Eris Jordan, Global Vice President of Clinical and Medical Affairs at Aurion Biotech. We are here at the 2024 ASCRS in our hometown of Boston, Massachusetts. Aurion has been busy at work. And it's been an incredible year so far, with several milestones that are coming our way, one of which is soon fully enrolling our first North American trial, which happily included Canadian sites as well. As we know, there's a great demand there of patients that are waiting in the queue to be treated [for] corneal endothelial disease. So we are very proud to say that we've enrolled this trial quickly, and very humbled with the amount of support and enthusiasm that we've received from our principal investigators, from our participating sites, and just the KOLs in this space. We continue to progress also with our endeavours internationally as we plan to launch our program commercially in Japan later this year. Our top line data for the first US and Canadian trial is expected later in this year, or Q1 of next year. And we're incredibly thrilled to just inch this progress a bit closer to the patients that need it, and look forward to giving you updates as we have them in future conferences. So, we're thankful to continue to report to you guys on Aurion's important work.

At ASCRS 2024, Aurion Biotech's Global VP Eris Jordan previews upcoming clinical data from North America and Asia

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