ASRS 2024: FARETINA-DME Study

Theodore Leng, MD, MS, sat down to discuss his presentation on the FARETINA-DME Study at the American Society of Retina Specialists meeting held in Stockholm, Sweden.

Video Transcript:

Editor's note: The below transcript has been lightly edited for clarity.

Theodore Leng, MD, MS:

Thank you so much for having me today. I'm Ted Leng, a professor of ophthalmology in the retina division here at Stanford University. Faricimab has been out since January of 2020 in the United States, and shortly thereafter in the UK [United Kingdom]. And what we want to do is look at the real-world evidence behind the use of faricimab in diabetic macular edema patients. Of course, we have the guidance from the phase 3 pivotal trials to go off of, but as we all know, a lot of patients don't qualify for clinical trials. There's under representation of certain populations in all clinical trials, and in the hands of physicians in the real world, we often use these medications very differently than they were used in these very controlled trials.

So this [FARETINA-DME] study looked at the American Academy of Ophthalmology's IRIS Registry, which is the largest specialty specific dataset in the world. There are over 540 million de-identified patient encounters. Seventy percent of all eye care encounters in the US are captured in this registry, so it is quite representative, going back to the point I made earlier about representative data. So what we did is, we took that data set and looked at patients who had a history of treatment with faricimab, and went through an algorithm to kind of whittle it down. So we looked at 2022 through 2023, and this study that we presented was actually a 12-month of follow-up study. We found over 71,000 eyes that had faricimab during the study period, and then we excluded eyes that had diagnoses besides diabetic macular edema from that cohort, and then also kind of screened for at least 12 months of follow up after the index date through March of 2024. Those eyes also had to have at least 2 visual acuity measurements after the index date. What that came down to was about 7,700 eyes with faricimab that we were able to look at. It broke down to about 13% of them were treatment naive, and the rest were previously treated, so [the] majority were previously treated.

We were expecting to see that the utilization of the medication would go down after the initial initiation period, or switching over a period, just like we saw in the phase 3 trial data. So we wanted to see confirmation that there were extended duration intervals in the eyes that were put on to faricimab. We did see that the number of injections did go down, and the way we addressed that in this study is that we looked at the first 6 months, versus the second 6 months after switching from the previous agent to faricimab. In this study, another thing that we were anticipating that a lot of eyes were going to be on aflibercept.

In this study, 61% of the previously treated eyes were switched from aflibercept. What we did see that in the treatment [was], naive eyes, on average, in the first 6 months after switching, they got about 3.5 injections, and in the second 6 months, it went down to about two injections. So there was kind of extension that happened after the first 6 months. And in previously treated eyes, which was a majority of the eyes, about 6,700 eyes, they had about 4 injections in the first 6 months on average. And then the in the second 6 months, it went down to about 2.5 injections. So that did confirm our findings that we anticipated.

Regarding the kind of interesting and maybe potentially surprising findings, we did see specifically with the anatomic data, we had OCT data available for a subset of these eyes, and then in both the treatment naive and in the previously treated eyes, the mean CST improved by about 30 microns in both sets of eyes. And so I think the interesting finding here was that even in previously treated eyes, which most likely were getting regular treatments with other anti-VEGF agents, once they switched to faricimab, the eyes improved anatomically, which I found to be particularly interesting.

Another interesting finding was the visual acuity. So in treatment-naive eyes, we had a gain of about 4 letters from baseline of the previously-treated eyes maintained their vision, and so we would surmise that a lot of the patients that were switched from 1 agent to faricimab that were previously-treated, were either doing that with a goal of maybe, potentially, extending the duration of therapy, given the phase 3 trial data with the extended duration intervals. I love these real world data studies, because it really gives us a glimpse into what is happening with these drugs, you know, once they've been released, and after approval and the marketing has started.

I think we should all be confident to know that these drugs are one, safe. The rates of, you know, side effects, complications, infections, and so forth, were very consistent in our real-world data study compared to the phase 3 registered trials, so that's number one. I think the second thing is that, as this medication has been out now for over 2 years, there's been a lot of experience with it, and so I think [it is likely being used] as a first-line agent, I think it started to be done. We did see, again, about 13% of the patients in the real-world, being used in treatment, naive eyes, and so I think we could be competent to initiate therapy with this. And the last thing is that is that visual acuity seems to improve, and we're getting good anatomic outcomes with these, this new medication, faricimab, in the eyes for diabetic macular edema.

So, I think there was nothing, at least in my mind that would give me any pause personally. I would continue to use this agent in my patients, as well as initiating new patients with faricimab.