What the data shows on myopia management
Gretchyn Bailey, NCLC, FAAO: Hi, everyone. I am Gretchyn Bailey. I am with Optometry Times®,and today I have the pleasure of being joined by Noel Brennan, research fellow at Johnson & Johnson Vision. Noel, thank you so much for taking the time to talk with me today.
Noel Brennan, BOptom, MScOptom, PhD, FAAO: Hi, Gretchyn. Thank you for speaking with me.
Bailey: Well, we are going to talk a bit about myopia, myopia control, myopia management. But before we do that, I wanted to ask you about your title, which is research fellow. Can you tell me a little bit about what that means?
Brennan: Sure. So, research fellow is essentially somebody who follows the academic path or the technical path as opposed to the managerial path. So, my talented colleague, Jacqueline Hernandez, is now leading the platform, which essentially is the D part, the development part of R&D. And I am doing the R part. So, concentrating on the science of myopia control.
Bailey: Excellent. So, you get to play in the lab and sit there and figure it all out and think about how we are going to solve this problem that is facing the world.
Brennan: Yes, I do not spend too much time in the lab. Mostly what I do is spend a lot of time on my computer. My research is largely in silico, rather than in vitro or in vivo.
Bailey: Got it. So, let’s talk a bit about myopia control versus myopia management. Some people are calling it myopia management, some are calling it myopia control, and management seems to be a slightly newer term. Is there a difference in your thinking, and does it matter?
Brennan: I think myopia management is a term that has been brought up to be all encompassing. So, it includes a situation where you might only correct myopia, for example, or even if you are treating binocular vision problems, things like that. And perhaps some companies are choosing to use that term because it avoids getting complex with off-label indications for product.
Brennan: To me, myopia control is about reducing myopia progression in an existing myope—that is the term that I use. And to be honest, it is my preferred term.
Bailey: That is interesting because I am hearing less and less myopia control and more and more myopia management. So, I am glad that I asked that.
Brennan: As well, I guess the myopia management is intended to be a very broad part of what is being done. So, perhaps more holistic, whereas myopia control is specifically about "let's slow down the progression rate."
Bailey: Got it. So, I know that Johnson & Johnson is doing a lot with myopia control, and you are behind a lot of that. Can we talk a little bit about where the company is and what you are looking to do?
Brennan: Johnson & Johnson Vision wants to bring a healthy lifestyle to all people within its reach. Our myopia platform is directed at this very thing. We are looking at numerous opportunities. We are conducting clinical trials. We have conducted clinical trials in the past, there will be more in future. And we are generally looking to create a fairly broad portfolio of products going forward. The company is investing heavily in basic research. We certainly want to lead with the science. And to that extent, we have this partnership with Singapore Eye Research Institute that has been running for over a year now. That is a $26+ million partnership that we have there. And it is looking at a range of different things. But a lot of it is basic research, trying to work out the mechanisms behind myopia, trying to come up with predictive analytics, looking at the disease state and what we can do with that, as well as looking at new product opportunities.
Bailey: Are you looking beyond contact lenses? Or is that the focus of where you are thinking we are for corrective opportunities?
Brennan: So, the thing that we say and we will continue to say is, "We are looking at anything that will work."
Bailey: That is a very good answer in many ways. One, of course, obviously, nobody wants to share what is going on before you are ready to share it. But, on the other hand, something has got to work. And if it is a combination of contact lens, or a spectacle lens at some point, or atropine, or what what can we do? Whatever will work, I think is where we need to go. Because there are so many people who are seeing myopia progress. And in different areas of the world, it is becoming a bigger and bigger problem. And something has got to be done.
Brennan: Well, that is right. Part of what we do is get an estimate of what is going to happen to people as time goes on. So, we have done a lot of work looking at the disease state. The picture that we see is pretty dire. One of the huge issues there is the public, many practitioners, and in some cases governments, etc, are so unaware of the negative effects going forward that we are going to have with myopia, because one of the things we say Johnson & Johnson is that this is the biggest eye health threat of the 21st century. We really mean that, because the escalation in the amount of disease that we see coming forward over the next few decades, it is going to be quite problematic. And that is putting it mildly, particularly for Southeast Asian countries.
Bailey: I know that there are some risk factors to kids developing higher amounts of myopia. So, there is the genetic factor. There is the outdoors factor, there is a lifestyle factor. Do we have any solid data yet on the effect of digital device usage? Whether that is because you are having a lack of accommodation by looking at something for a long period of time, or by virtue of the fact that you are looking at a screen, you are not outside looking at a farther away focal point or getting some vitamin D. Do we have any data on that?
Brennan: So, there is no clear data that links digital devices and uses of digital devices to increased myopia progression or even myopia onset. There are a couple of reasons not to believe that there is a relationship. For example, the myopia problem has been around since at least the 1980s. We didn't have handheld digital devices or smartphones back then. If anything, you might look at more at laptop or desktop computers. Not that we have strong data in that regard, either.
The other thing is, there is a theory about peripheral hyperopia being a driver of myopia development. If you think about looking at a handheld digital device here, this is not peripheral hyperopia, if you are focusing here, this is peripheral myopia. So, you might even think perhaps a small area in which one is looking up close might be even protective, rather than myopigenic, per se. But clear thing is, is there is no no straightforward data.
But what we do know is that spending more time outdoors is protective One issue about this lifestyle that we live now, if children have spent a lot more time on digital devices, they are going to spend a lot less time outdoors. So, it may not be a direct relationship, it may be an indirect relationship. And you know, I think everybody just agrees the less time kids spend on digital devices, the more time they spend outdoors, the healthier as a person they are going to be.
Bailey: Which is a bit difficult given where we sit now in a global pandemic with kids spending just about the same amount of time on their devices as people like you and me, given that they might be doing school online. So, that is a challenge.
Do you think that with with this pandemic, if we fast forward a year or 2 that we might see an increase in myopia due to the fact that kids are not going out for recess? They are inside doing this school online and they seem to be more structured in front of screen at home, then they might be in a school setting.
Brennan: Well, they might be more structured on a screen at home than in a school setting, they might not as well, depends on how the adherence is, and, perhaps how involved the parents are with work and whether or not they have enough time to make sure that they are well structured. Looking at devices, you would have to say, there is a high likelihood that children will be spending less time outdoors. That may not be the case. But if that is the case, then you would almost certainly link it to a greater amount of myopia going forward.
I know our colleague Dr. Thomas Aller has said, "Well, maybe we are not seeing such a big increase here" from his experience in practice. And I am not sure sure why that might be. But certainly, it is a concern. Everything you say makes one think yeah, there is potentially a problem here.
Bailey: Let us switch gears for a minute and talk about axial length. I know that is important in taking a look at progression of myopia. But for most practitioners, if not all practitioners in a clinical setting, unless you are at a research center, you are not going to have access to measuring axial length. Is that going to be a challenge for practitioners who want to track the progression of myopia in their patients?
Brennan: It is something of a challenge. Let me say first off, though, very much that we don't think that you must have the capability of measuring axial length to undertake myopia control. You just need to be aware of what the limitations to refractive error measurement are. Ideally, everybody is able to measure axial length and axial elongation. And with optical biometry as the preferred technique because of its high accuracy, we think down the track that that is going to become more of a standard of care, as time goes on.
But certainly you shouldn't not do myopia control if you can't measure axial length. The key elements here are that optical biometry on a relative basis is so much more accurate than refractive error measurement. Optic axial length has been linked more closely to the development of disease than has refractive error.
For example, orthokeratology, your refractions are not going to be great if you have bent the cornea, essentially to correct myopia. So, axial length is clearly superior under that circumstance. Even with atropine, where we see differences that are unresolved between refractive change and axial elongation, axial elongation is going to be a better way to go there. So, that is the preference.
With refractive error, you need to be aware that your ability to measure progression over a year or so is around about the same as the variability of the measurement system you are using. So, the signal-to-noise ratio is not wonderful; you can get a really good idea of refractive progression only over a number of years, per se. I think if people are aware of that when they are doing any myopia control, they need to be cautious about being too reactive to what they are measuring with refractive error.
Bailey: Got it. Let's talk a bit about research data. Recent research data that I know that J&J has had some recent posters, papers, presentations. What key points do you think practitioners should know about the research that is coming out of Johnson & Johnson Vision?
Brennan: So, one of the big deals that we see right now is this reporting of myopia control as percentage figures, and this is misleading. We really need to get away from it. What we find is that you get an absolute decrease across a variety of different factors, whether it be progression rate, age, even ethnicity. So that, on average, your fast progressor is getting the same reduction in axial elongation as your slow progressor. It is not working as a percentage. And the percentage is a group mean—it doesn't help you work out what is going to happen with an individual.
In addition, it myopia control efficacy decreases over time. There is a study from Japan on orthokeratology where there's a 50 percent reduction in axial elongation in the first year. By the fifth year, there was only 6 percent. On average, over the 5-year period, it was about 30 percent. So, talking in percentages is really misleading.
And you are potentially going to give false hope to parents about what can be achieved with their children. So, as an example, if you have somebody who's 6 years old, who is -1.00 D and you estimate that by the time he is 17 or 18, he might be -7.00 D or -8.00 D. If you say he is going to get a 50 percent reduction, you are going to bring him back to -4.00 D, something like that. Well, what we have observed is because of the nature of how we can achieve control, you may get only about -1.00 D. And so that is a big difference in terms of expectations. And when we look at all the data, nobody has achieved more than about 0.4 mm in any study, which is equivalent to around about -1.00 D. So, we need to get our expectations firmly under control and not promise too much.
Bailey: That is an excellent point. So 1.00 D. So, if you have parents sitting in front of you, and you are talking with them about the potential progression of their child's myopia, is 1.00 D worth the trouble, the expense? What do you say when a parent asks you that?
Brennan: That is a really good point. Because the 50 percent is kind of like promising maybe 3.00 or 4.00 D. Now, one of the good things is: most kids don't progress to become so highly myopic. So, in practice, because you don't have a control group as well, you can't tell how well you are doing in terms of reducing myopia progression. And there is a whole lot of things that are stacked in the optometrist’s favor that make them look good. Progression is going to slow down over time naturally anyway, for a start. So, often, you will get the impression that you are getting a really good effect. That seems to be reassuring, but it can actually be some something like false hope. But this 1.00D thing, I am saying that is all we able to show from an evidence base right now. You know, maybe you are getting more. And not everybody gets exactly 1.00 D—some kids will get more, some kids will get less. But that is about what we think.
The key thing is that in terms of risk of disease later in life, 1.00D makes a huge difference. So, for example, with macular degeneration, each individual diopter of myopia increase raises the risk of getting macular degeneration by 67 percent or thereabout. So, you will reduce it by 40 percent per each 1.00 D you can pull the patient back. And that is very significant and a very significant public health benefit. And certainly, under those circumstances, we also believe that the benefits outweigh the risks, if that makes sense.
Bailey: So, if we look ahead, what do you anticipate that we will see in terms of new research. new data? What should we be watching for say, ARVO time, next year's Academy? What should we keep our eyes out for?
Brennan: Lots of things. And I will be vague about some of the answers I give to this. But, look, I think as we go forward, we are going to understand more and more about what we can really achieve in terms of efficacy. And Johnson & Johnson is driving a lot of this work in consultation with Dr. Michael Moore, who is well known, as well. I think also understanding the disease processes and the benefit we will get from reducing myopia progression, that is going to be another increasing thing as well. We are spending a lot of time there.
There are some developments that we will be sharing over the next 12 months or so about our learnings, in terms of what we can do with optical treatments to slow myopia progression. And some we have been studying now for a decade or more at Johnson & Johnson. And we have learned some things. We are going to start sharing some of those things about how we can get maximal effect in terms of reducing progression without causing too much detriment in vision and vision performance. So, these are some of the things that we are looking forward to sharing over the next 12 months or so. And you will see some of this material at ARVO.
Bailey: Excellent! Something to look forward to then.
Bailey: If you could offer one takeaway to practitioners out there considering getting involved in myopia control or those who are already there, what would you tell them?
Brennan: So, one of the other things that we have learned is that the risk for young children under the age of 12 of becoming highly myopic later in life is high. So, you should recommend treatment for every child under about 12 years of age. That should be the default, not the exception. You may not treat them all, and you may have a reason for doing that. But that should be the exception rather than the rule. We believe all young myopic children deserve the opportunity to be treated.
Bailey: Do you see myopia control becoming standard of care?
Brennan: Yes, absolutely. And when we go over that place, I am not quite sure when that will be. But in my mind right now, it should be the default and the standard of care.
Bailey: Well, good advice and stuff to look forward to for our upcoming meetings at ARVO, Academy next year, more to come. So, thank you very much for talking with me today, Dr. Brennan, and I am sure we will be talking again about this soon.
Brennan: OK, my pleasure. Thank you.