Clinical Trial Evidence in Geographic Atrophy

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Veeral Sheth, MD, MBA, discusses the clinical trial data that led to FDA approval of SYFOVRE and IZERVAY for geographic atrophy.

Veeral Sheth, MD, MBA: I'll take a second just to dive into some of the clinical trial evidence that allowed these treatments to get to us with the FDA approvals. And so for the first drug SYFOVRE, we had mentioned OAKS and DERBY. OAKS and DERBY were the big phase 3 studies that really looked at patients with both central and non-central geographic atrophy. And what we saw in both of those studies is a significant reduction in GA lesion growth and we saw that in one of the studies, we saw a significant P value, and in the other one we did not, not at the one-year mark.

But the good news is that at 24 months, we seem to find that the divide between the patients that aren't treated and the patients that are treated, continues to grow. What does that mean? So in the two-year data, we saw that in the OAKS study, for example, there was a 22% reduction in GA lesion growth versus the sham. And in DERBY, we saw a 19% reduction. But what we see is that the delta between those two groups, the study treatment group, and the sham group continues to separate over time.

The way I think about that, and the way I talk to my patients about that is with treatment, we're going to shift the course of your disease. And so what I tell people is, there's a likely chance that a year from now after starting treatment, or two years from now, that we've potentially allowed you to have less vision loss, less spread of that atrophy, then if we were to not have treated you. That’s the way I positioned kind of the treatments and the benefits of these treatments. And so that's the SYFOVRE data.

If we talk about the IZERVAY data that came from two studies, the GATHER1 and GATHER2 study, in the GATHER1 study, we saw that there was a 35% reduction in the treatment group versus sham. In the GATHER2 study, we saw about 17.7%, that's 12-month data, we should be finding out about the data beyond that pretty soon. And this study was a little different. This looked at patients who did not have central GA lesions and so there is a difference there. I think one thing that is very important to note with both of these clinical trials, is not only the efficacy but the safety, right? Safety is so important and again, is really an important bullet point that we talk to our patients about. In both of these studies, we sign an increased risk of choroidal neovascularization (CNV) rates when you treat patients with these agents. I do counsel my patients about that, in fact, I have patients in the clinic who do some research on this, and then come to me and ask me specifically about this increased CNV rate that we see with treatment. And I do tell them look, there is a chance that if we do start treatment for your geographic atrophy you may develop wet macular degeneration. Now, we know that that can happen without treatment because there is an increased risk in patients with GA to develop CNV, but there's potentially a slightly higher risk with these treatments and so again, that is something that I counsel patients about.

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