Current and Emerging Treatment Options for Age-Related Macular Degeneration - Episode 8

YOSEMITE and RHINE Trials for Patients With Diabetes and AMD

Two specialists examine the YOSEMITE and RHINE clinical trials that explored faricimab as a therapeutic option for patients with both diabetes and age-related macular degeneration.

Karl Csaky, MD, PhD: Lloyd, you’re in the diabetes belt there in South Carolina, and I’m sure you see your fair share of diabetics. Let’s talk about faricimab in diabetes because there were the comparable trials for diabetes, YOSEMITE and RHINE. Can we talk about your impressions of those trial results and your thinking in regard to faricimab for diabetes and how you are going to think about implementing it in your large diabetic practice?

Lloyd Clark, MD: The interesting thing about the faricimab trials in DME [diabetic macular edema], you think about diabetic eye disease and it’s more a purely VEGF-mediated disease, at least that’s our understanding of it. We’re adding this second mechanism of action, which we don’t completely understand all the issues related to it. You wonder is there a differential response in patients with diabetes vs AMD [age-related macular degeneration], because in AMD, although a VEGF is an important mediator, clearly it’s a multifactorial process that’s causing vision loss.

As it turns out, the phase 3 data, at least to date, have demonstrated pretty similar results with faricimab in diabetic macular edema compared to age-related macular degeneration. We see comparable visual acuity gains to on-label aflibercept, with treatment intervals out to 16 weeks. This idea that roughly 50% of patients can be extended to 16-week intervals and about 75% of patients last at least 12 weeks. They are very encouraging data in a different patient population, where they have more compliance issues, they’re busier, younger, they have a lot more on their plate in terms of their medical care than some of our patients with AMD. The idea of having a drug that has similar clinical benefits to the best drugs available for diabetic macular edema, and can be used significantly less frequently, is an attractive choice.

We’re not going to have this probably in our hands in the clinic for a little while longer. These clinical trials are longer, the approval process is a little longer in diabetic macular edema than age-related macular degeneration. But like in AMD, faricimab has tremendous promise as a great drug for more severe cases of diabetic macular edema, but also as an agent to manage disease chronically, with a reduced treatment burden.

Karl Csaky, MD, PhD: We’re going to peer inside Nancy’s brain for a second. I’m curious about your thoughts on YOSEMITE and RHINE, also in the context, the data we’ve seen are that there are a group of patients who don’t respond within the first 3 injections, 4 injections of anti-VEGF in the diabetes world. Thinking about the complexity and how the faricimab data struck you in terms of the overall, again, we only have 1-year data, but in terms of how you treat those patients, what is your decision-making, how quickly do you change, all that kind of thinking?

Nancy M. Holekamp, MD: What impressed me about YOSEMITE and RHINE is I thought the anatomical results were more favorable than I was expecting, and there was a bigger difference between the aflibercept group and the faricimab group looking at the anatomy. I thought there was better drying. I’m thinking to myself that this may be validation in our clinics that targeting a second pathway may be helpful for our patients with diabetes. I look forward to the year-2 data, which may tell us more and create a bigger difference between the 2 agents as we collect the data.

This transcript has been edited for clarity.