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At ARVO 2025, in Salt Lake City, Utah, Ferhina Ali, MD, MPH, talked about her presentation on the early real-world use of aflibercept 8 mg in treatment-naive patients with neovascular age-related macular degeneration
Video Transcript:
Editor’s note: The below transcript has been lightly edited for clarity.
Ferhina Ali, MD, MPH:
Alright well, good afternoon. I’m here at the ARVO meeting in Salt Lake City from New York Medical College and West Chester Medical Center. I’m a retina specialist. And I’m here presenting for the first time real-world early data on the use of aflibercept 8mg. So we looked at patients in this real-world cohort using the IRIS registry as well as the Vestrum database. And these were patients that received the very first treatments in August of 2023 out to June and July of 2024 for those two cohorts.
And the size of the cohorts were quite high in terms of this early study. So the size of the cohorts were impressive, in almost 3000 eyes receiving injections from the IRIS database, and for the Vestrum, almost 1300 eyes. And so what we looked at in this again, these were patients that were treatment naive, treated for neovascular AMD, we saw some improvements that we might expect. So patients that had vision of 20/50, or worse, we saw meaningful improvements in their vision as captured through the database. And then, of course, we’re going to be very interested in durability.
Particularly, we saw with the PULSAR clinical trial data, really impressive durability with a aflibercept 8mg in terms of kind of the defined criteria allowable through those clinical trials, and the pretty significant extension in treatment intervals seen in the trials. But our question, of course, will be, what are we seeing in the real world, and is it similar to what was seen in the trials? And so we were able to look at, again, a small cohort, since the product has not been available for that long, and our cohort is still small. But we looked at an initial dosing period. So the index date, that first injection, followed by either 3 injections or 90 days within that early period, that was our initial dosing phase.
And then we looked at the follow up cohort as well. And so we’re looking primarily at what sort of interval are we seeing at the end of the cohort? And what we found is that, on average, we saw an interval at about 10 weeks, as measured by this database. So meaning the potential for extension and durability up to that point based on how we’re following this cohort at this time. It is still early, and the data will continue to mature, and we’ll be able to look at this data set in a more timeline based approach as well. But for now, we were able to split it up into the initial dosing and the latter period, and those are the results that we saw.
So we excited about it. We certainly know that this treatment is both efficacious and safe based on the clinical trial data. And we’re seeing efficacy that we might expect in terms of stability of vision for those folks that had good vision on presentation, and for those folks with less good vision, we see good improvement, as we might expect. With time, we’ll have a longer term cohort, and we’ll really be able to understand that durability component, that is the number of weeks that patients can go between their 8mg aflibercept treatment as compared to the 2mg and other treatments that are available today, so it’s exciting, and we look forward to more data from this cohort and more presentation.
So we’re always interested in validating what we see in the clinical trial setting. We know that clinical trials are a very specific cohort, and those patients are sort of very strictly followed, and they adhere to various aspects of a protocol that really allows us to understand a potential therapeutic and allows us to then use it in the clinic, but we’re always going to be interested in real world data to see if it mirrors what was seen in the clinical trials, and then that helps us inform our decision making for kind of what treatment intervals may be possible for the patient. For example, once we have the drug commercially available.
So that is one thing, and then secondarily, we’re always going to be interested in real world safety. The patients that are included in clinical trials do have to meet strict criteria in terms of their allowability, and that may influence kind of, I would say, the, you know, maybe the specificity of the safety that we see in the trials, but once the product is available for everyone to use, for any patient, then we kind of really can know what the range of the safety can be. We haven’t yet explored that with this cohort, but we plan to, and then we’ll be able to kind of offer that information for providers and patients to know in the real world setting.
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