Focus on Geographic Atrophy

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Dr. Chris Wolfe: [00:00:00] Hello and welcome to the Crystal Podcast on ICU Edia. Today I had a great conversation with Dr. Nate Light Heiser. We discussed geographic atrophy and macular degeneration treatments that are now FDA approved and coming forward. We also talked about intravitreal injections, which is a ton of fun to kind of think through what the future will hold both for patients and then also for the profession.

If you haven’t heard Nate, uh, you really need to listen to him beyond just the conversations that I have with him. He is an expert in our field related to surgical management of patients with lumps and bumps and glaucoma care and postoperative cataract complications like. Uh, capsulotomies and like, uh, posterior capsular opacities, but even beyond that, he is, he is well thought out in his reasoning.

He dives deep into the literature. I always love to, to catch up with him. So please enjoy our conversation. As always, be sure to subscribe to the podcast, write a review, share it with your friends, and support [00:01:00] those who support us.

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Well, thanks for doing this. Um, no problem. I, I figured that, you know, since this was, you know, I guess it’s technically surgical because we’re discussing an intravitreal injection, um, that it was pertinent to kind of the innate light heiser surgical minute. And, uh, what I was hoping to kind of [00:04:00] discuss is, you know, I was at a, uh, a retinal conference, um, What it was is a whole bunch of retinal surgeons who are in a private equity group, they got together, they wanted insights from optometry, how to better support, referrals, et cetera.

So there were about four of us there. And, um, and it was the week or two after, um, this medication, sva, sva, do you know how to say it? I, I don’t set the plan. Peg, peg 

Dr. Nate Lighthizer: Copeland. Pce Copeland, Coplan. You know, that’s what 

Dr. Chris Wolfe: I wanted. Probably get it better than I Copeland. Yeah. Let’s over. I don’t know. Yeah, could be.

Yeah. Either way. Anyway, it’s not the best name, you know, because it is harder to, but that’s how they go, right? Yep. Um, so in any case, It had just been approved maybe the week or two before, and my impression of it was, I’m not sure exactly where it’s gonna fit. And, and actually the group, the group of retinal surgeons were like 50 50.

You know, one hand of the group was like, well, [00:05:00] anything we can do to slow down the progression of ga fine. And then the other group was, okay, well no, there’s gonna be some drawbacks. We don’t know exactly where it’s gonna fit. So that’s what I hope we, we would discuss today or what, what you think it is.

And the last thing I thought, And this is where I want to get your perspective from a surgical standpoint as well, is, um, the, these guys do are not gonna have the time to do this many injections. 

Dr. Nate Lighthizer: No, and that’s, I pulled up an article here and I’m, I’m trying to, I’m looking at where they, uh, where did they say it?

Um, Dr. Han, who’s, um, at this is a m md, uh, in Iowa. Uh, he said, Dr. Han explained that many practices are already strained with high injection burden from wet amd. I mean, they’re admitting it going, man, the burden is incredible with these intravitreal injections for wet amd. And now we’re adding another indication in here.

Um, we know, uh, [00:06:00] PAs, nurse practitioners, uh, and, and PAs are doing. I think ods are well equipped to, to start to handle this burden. So we’ll, we’ll see, uh, down the road how that, how that shakes out. But as the technology gets better and better, and we know this is the first one from app PS Iric, bio HA is a, is the next one that’s coming with another medication, uh, probably six months out.

Um, so as this gets more and more, um, you know, will this fall into ods wheelhouse potentially. . 

Dr. Chris Wolfe: Yeah, I mean, I think it’s gonna be, you’re gonna see one of two things happen because the system will absolutely break. You know, we’re talking about obviously scope of practice now, but, um, either MDs will incorporate, you know, retinal surgeons are gonna have to incorporate more, uh, PAs and nurse practitioners into their practice to do nothing but push medications.

Um, and probably even interpret whether or not, you know, a fit or standard protocol. You know, a patient is at treat and extend. Every month or [00:07:00] bimonthly injections depending on their medication that their FDA approved medication or quarterly injections. And they’re just gonna follow that protocol and just bing, bing, bing, binging.

Doesn’t matter. We’re gonna look at their scans really quickly. Inject, inject, and, and so, um, or you know, obviously it’s gonna have to be done in the hands of optometry and you and I know that there’s nobody better trained to do that. Um, and you know it’s gonna have to happen. It’s just how tightly they’re gonna hold onto that, to that little grip of.

Yeah. Or a major 

Dr. Nate Lighthizer: grip of power. Yeah. As you know, it’s a slippery slope. And that’s their argument in many states is we can’t let you do this cuz then you’re gonna wanna do that. But you know, again, I I, I agree with you. The system is going to break at some point and we ju they can’t handle the load of this.

And, um, I, I think it’s time for optometry. I mean, know I have an interest, I know of other faculty members that go, man, we could be well equipped. To help these patients get more local treatment, more timely treatment. Um, so I, I think it, you know, who would’ve thought 50 years [00:08:00] ago, optometry would be doing what we’re doing today?

So may, it may be tough for most of us, I think you and my me maybe excluded, but many of us, maybe even us as well, it may be tough going, man, are we gonna be doing in intravitreal injections? That may be tough to imagine today, but it was tough to imagine laser procedures 40, 50 years ago, and now look where it’s.

Um, so I think it’s evolving and, um, who knows where we’ll be in 5, 10, 15 years, if not sooner. 

Dr. Chris Wolfe: Yeah, I agree. I I mean, I think, you know, to your point, it, it’s, you know, you and I would, might be considered cowboys to some, but, but the reality is, is that. Um, you know, when I think about doing an in intravitreal injection, there would be a lot of stuff I, I’d want to go over a ton of cases with a guy right next to me.

I mean, just, just thinking about what, you know, what are the, what are the risks? Okay. What, how do I place it there? What if I place it there? You know what I mean? Like, you just get more comfortable with it. But, but certainly it’s, it’s at that, that threshold of, of something that technically optometrists can perform and ought [00:09:00] to, if the, the training is.

Dr. Nate Lighthizer: Well, you and I both know that we as a profession, and I think you and I included, we are a conservative bunch. We’re not gonna be just jump, Hey, gimme a needle. I’m gonna start, you know, shoving into people’s eyes. We would want to be incredibly well trained. Oh yeah. Before we would jump into this, just like the things that we do now, I mean our.

Our 32 hour advanced procedures course is so above and beyond what any ophthalmologists get in terms of formal training for this. Um, you know, as they added these new procedures. Well, I’ve had so many tell me they just got kind of thrown in. There’s the SLT laser, there’s the YAG cap. Figure it out. Um, yeah, read the book night before we, we had an ophthalmologist that attended our course when we gave it in London, in the uk and said this was the best laser training that I’ve ever seen before.

I wish we had had. when we, when I got trained on lasers, way back when. But so we know that if this were to ever come about down the road, whether it’s 25 years or five years, that we would be incredibly well [00:10:00] trained, we probably would involve ophthalmology in this. Um, you know, I know, you know, Leo scoring, I did a four month rotation with him, and that was my first experience into intravitreal injections.

uh, watching him do these and it was fascinating. This is back in 2008 and he was doing a bunch of these then. So, uh, yeah. The, the training evolves and we would certainly, uh, be well trained on that, uh, before this would ever happen if it were to happen down the road. 

Dr. Chris Wolfe: Yeah. Well, I, so let’s, let’s, uh, let’s pause that cuz we could, uh, go on and on.

Sure. Um, but for the, for Sephora, sva, Sephora, Sephora, , um, the. Tell me your impression. So when I look at this study, you know, if I remember correctly, it is a 27% reduction in geographic atrophy size. Um, or, or, or actually, what was it? It was 27% of patients had a reduct, a slowing of their progression. Of ga, correct.

Am I remembering this correctly? It was a few weeks ago that I read 

Dr. Nate Lighthizer: this. Yeah. [00:11:00] It didn’t reverse anything. It, it didn’t, um, you. Uh, it, it slowed the progression. You know, it didn’t stop it, it didn’t halt it there, it depended on whether it was monthly or every other month that, you know, they did multiple studies, the Derby and the Oak study.

Um, some of ’em were every month. Some of ’em were every other month. Um, and it ranged between about 17% up to 32. A slowing of progression depending on what time period they looked at. And depending on whether it was every month or every other month, uh, the highest percentage that I saw was a 36% reduction in the rate of progression.

If they had it every month, if the injection was every month. And the biggest benefit was between 18 and 24 month point time period. So I think one of the take home points is this is not an A one time injection, or you get it every month for three months or six. It was, uh, this is gonna take a year to two years to see the maximum benefit, at least based on the trial.

Uh, so much [00:12:00] to be learned still on this, but we haven’t had anything before this, and now we have something for GA that at least slows the progression in 

Dr. Chris Wolfe: some. And so, you know, to, to think about that. I mean, certainly this is gonna be. I mean, I, I don’t hate to speculate on how expensive the medication is gonna be, but it’s gonna be expensive for sure.

Which means, you know, you’re gonna have, and you probably already looked at that, so you probably have, I can tell you how expensive it’s 

Dr. Nate Lighthizer: gonna be. I found the 

Dr. Chris Wolfe: glass. Yeah. How expensive is it gonna be? Um, 

Dr. Nate Lighthizer: it will be market under the brand name Siff over what, however we pronounced that, and it’ll be priced at $2,190 per vial.

The company announced on Friday, so 2190, uh, so nearly, so 2200. . 

Dr. Chris Wolfe: Yep. For two years. Every month. That’s 50 grand basically. 

Dr. Nate Lighthizer: Yeah. And then again, they will tailor it. You know, I read one thing where it said, okay, it’s gonna take six to eight vials to start to see the best effect. So maybe they do it monthly for a while and then every other month.

But even at eight vials, at [00:13:00] $2,200, you’re still approaching 20 grand, uh, for a treatment. So certainly that there’s gonna be a, a cost factor in this.

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You know, my clinical, so, so then the downside is, as I recall, that there is about. 13% of patients that transferred to wet macular degeneration are converted to wet. But in the, in the placebo group, there was like, I don’t know, 5% or seven. So the difference was maybe a 7% difference. So it’s a number needed to harm from dry to wet of something like one in 12, uh, if I remember correct.

Is [00:16:00] that, am I thinking about that 

Dr. Nate Lighthizer: right? that that’s what, what I remember as well is, yeah, there’s a slight uptick in conversion to, you know, wet macular degeneration. So obviously, you know, we’ll have to decide as clinicians, if the patient is wet in one eye and has geographic atrophy in the other, will that be an indication or not?

Because you certainly wouldn’t want their one remaining if they have extra foveal ga. And likely still have pretty good vision then, you know, would we want them to be one of that seven or 8% that then converts into wet when the other eye’s already gone from wet. So those are the questions I think we’re gonna have to figure out, uh, going forward, since it’s only been approved for, you know, two to three weeks at this point.

Dr. Chris Wolfe: Yeah. Yeah. I think in the last question is in the, in, you know, You might have some other points that, that you’ve thought through, but you know, as I’m thinking clinically about this, the conversion from dry to wet is, is a major one. The other one is, you know, it probably makes sense if you’ve got patients that have central, you know, subfoveal, geographic atrophy, um, and you know, [00:17:00] they’re 2030 to 2040.

And they have still really good, you know, para foveal, uh, or, or um, eccentric viewing capabilities where they can get some usable vision. You know, these are really rare cases as you know, you know, it probably makes some sense. Not a lot of downside to that in the sense of like if that patient converts to wet, they convert to wet, they had no central vision anyway.

But if you’ve got. And we can, we know we can get that better. You know? We can know. We can shrink that up for sure. So even if they go from 2050 to 2100 cuz of wet or 2200, we could probably get ’em close to 2050 again. So probably not a lot of downside. My thought is those other patients that might longer term be more beneficial to use this medication are those patients that have non subfoveal geographic atrophy, because you don’t want that non subfoveal ga to kind of invade into the subfoveal space.

The challenge there is those patients could be 20, 25, 20 20, you know, uh, they’re certainly not functioning normally, but they could have a really [00:18:00] robust central. and now all of a sudden we have a bigger risk. So, but then at the same time, you know, they could benefit because you don’t want that GA to spread.

So that is, I don’t know if you’ve thought more about that, but that’s kind of the uncertainties in all of this, where it’s not just an easy gut referral, you 

Dr. Nate Lighthizer: know? Correct. Yeah. And I think it’s all gonna be, we all have different risk tolerances. What’s our risk threshold? I mean, if it, this was your parent or my parent, and they had that exact situation that you just.

you know, they have extrafoveal ga, their vision’s pretty darn good. But we’ve all had patients that went from pretty darn good vision to there, went the ga and over the course of a number of visits, now they’ve got central. And they went from what, 20 25, 20 30 to now they’re worse than 2100. Correct.

You’ve had that patient? Yep, yep. I’ve had that. Could this help? Yes. You’re going to have that same risk of Yep. We injected them. They were one of the small [00:19:00] percentages that converted to wet. If it was me and my parent, I would say that’s worth the risk because I, if you go to 2,400 with central ga, we ain’t getting that back at this point.

Right. Versus if you go. , we at least have Avastin, Lucentis, Eylea. That can bring you back, hopefully a little bit. So I would lean more towards the, towards the injection and we’ll deal with the complication. But again, that, that’s all depends on our risk tolerance and, and the individual patient. 

Dr. Chris Wolfe: Yeah, I, I think that’s, I mean, that’s the, that is the, um, that’s gonna be where we find out how this works.

And then, you know, down the road we also have the, the capabilities I. Wait, were they in phase three yet? Or just, just finishing up phase two. But we have some light-based therapies, uh, that is, that are being explored for, uh, four category three. I can’t remember if GA was involved in it. I’ve gotta go back and look.

But anyway, you know, I 

think 

Dr. Nate Lighthizer: legal was. . Yeah. It’s a company called [00:20:00] Luma Thera studying lura. Yep. And they are finished with phase three, so they’re Yeah. That, that actually has been submitted to the FDA at this point. It’s not FDA approved, but using photobiomodulation for Dry AM MD Inclu, I believe, including geographic atrophy.

So there’s another potential treatment down the road, um, to help these patients. Yep. Yeah, 

Dr. Chris Wolfe: I think the company thinks they’re gonna get. Which is a whole other conversation to have, but I think they think they’re getting, they think they’re getting approval and um, so they must know that the results are probably pretty powerful in that case.

You know, as long as, I can’t imagine there’s a ton of downside. I don’t know if, I haven’t seen much downside being reported just yet, but, um, you know, I think the ultimate, the thing is, you know, macular degeneration, our abilities for intervention are continuing to evolve and it’s pretty exciting. 

Dr. Nate Lighthizer: Oh, absolutely.

I mean, I, I wonder if we will look back 20 years from now and, and think, you know, we think back 30 years ago in glaucoma [00:21:00] when there was no SLT and there was no migs and there was no prostaglandins, you know, way back when you’re treat with pylocarpine and now we go, well look how it’s evolved. And I wonder if that’s what we’ll look at 20, 30 years from now when it comes to macular degeneration going, remember when we just had to give ’em eye vitamins and that was, that was it.

And we watched them lose vision. Uh, hopefully that’s the case 20 years from now is, is we can look back and go, man, we’re glad we don’t have to do it like we did it back then and we got much better options. And I think that’s where we’re probably 

Dr. Chris Wolfe: going. Yeah, agreed. So, Dr. Light heiser, this is an awesome surgical minute.

I wanna be respectful of your time. Tell everybody as always where they can check you out and find 

Dr. Nate Lighthizer: you. Yeah, I’m at, uh, the Oklahoma College of Optometry, uh, here in Taliqua, Oklahoma. I am on LinkedIn, um, and available, uh, via that or, um, any other means. 

Dr. Chris Wolfe: Awesome. Thanks Nate. Appreciate it.[00:22:00] 

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