Intraretinal hyperreflective foci, intraretinal hard exudates, and epiretinal membrane formation were lower after treatment with faricimab (Vabysmo) compared with aflibercept (Eylea) for patients with diabetic macular edema (DME), according to an analysis presented at the American Academy of Ophthalmology meeting.
In this exclusive 鶹ý video, Jennifer Lim, MD, of the University of Illinois Hospital and Health Sciences System in Chicago, discusses the findings.
Following is a transcript of her remarks:
Specifically looking at biomarkers, we showed that intraretinal hyperreflective foci, hard exudates, were markedly lower in the faricimab arms compared to the aflibercept 2-mg arms. And then also looking at ERM [epiretinal membrane] formation, which on average occurs at about 9.5% at 1 year in any anti-VEGF treated DME eye, it's quite high, as you know. In the studies, it was lower in the faricimab arms at 1 year and also at 2 years. So that lends me to think, the anti-Ang2 [angiopoietin 2] component -- which is anti-inflammatory -- really is having some sort of effect. So I look at this as the anti-Ang2 component biomarker, which is having an effect in faricimab-treated eyes with DME.
I just want to emphasize that there is a 9-month difference in the time to first drying of the retina in the faricimab-treated arms compared to the aflibercept 2-mg arms using the Kaplan-Meier analysis and looking at the 75th percentile of that achievement. So that again, tells me that there's some effect of the anti-Ang2 compared with just an anti-VEGF. And also when we look at the head-to-head analysis, both in the AMD [age-related macular degeneration] trials as well as in the DME trials, again, we see better drying in the combined anti-VEGF/anti-Ang2 with faricimab than we do with aflibercept 2 mg.
And furthermore, when we look at PHOTON and PULSAR and we look at the OCT [optical coherence tomography] data, we don't really see a difference. We don't see a difference in terms of the drying between the 2 mg and the 8 mg, although we do see durability. So again, I think that points to different mechanisms of action and a better effect that you can get when you use combined mechanisms of action.
A lot of these eyes came in with relatively reasonably good vision, and these drugs could get rid of the vast majority of the fluid. The durability effect was also an added bonus, but that little differential amount of drying doesn't really play out in terms of vision, at least at 1 and 2 years. It may further down, and it may also contribute to durability, but at this point we don't see a difference in the visual acuity.