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Veeral Sheth, MD, MBA discusses safety signals reported with the use of approved therapies for geographic atrophy and the importance of real-world datasets.
Veeral Sheth, MD, MBA: I think one of the things that's critically important to us as clinicians who want to really help our patients is that with new therapeutics, we really are vigilant and really focused not only on efficacy but on safety as well. And recently we've seen some cases of intraocular inflammation that have been reported with SYFOVRE. And I think it's an important kind of point to address, to discuss. And it’s well known enough where patients are coming in asking about it and bringing in internet articles where they've said, hey, look, I've noticed that there's inflammation about this, and this is in patients that have already been treated with SYFOVRE, and patients that have been thinking about it. And so I think it's an important thing for us to think about, address, talk about, and learn more about as clinicians because we're going to have to understand exactly what's happening. And the scale at which it's happening. At least, at this point, we think that these events are fairly uncommon, I think, one in 10,000 is the rate that's being quoted. And even that rate will be refined further, as we start to see kind of what's happening in the real world as we get a better idea of, hey, how many doses have been administered? And how many of these cases have there been? We're going to further refine what the reality of that is. But right now, like with any new treatment, we're still in that phase where we're trying to understand what's happening, so we as clinicians know where are we going to kind of use these treatments? And how are we going to counsel our patients? And if we do see a case like this, what do we do? As clinicians, I think we're really more vigilant than ever about this kind of stuff. And, and we will be really focused on it. And I think this is where real-world datasets really help. We saw with recently approved agents such as faricimab (Vabysmo), we know that there are real-world datasets coming out, left and right. Truckee was one of the first ones and from those datasets, we got to learn a lot because we started collecting data that wasn't always collected in clinical trials as well. So we're going to learn a lot about efficacy. We're going to learn a lot about safety. And I think that you know, clinicians banding together and kind of coming up with these data points is really really important for us to educate each other as a field.