Unmet Needs in AMD and DME
Drs David A. Eichenbaum and Caroline Baumal discuss unmet needs in treating AMD and DME.
David A. Eichenbaum, MD, FASRS: Caroline, we talked a lot about faricimab. One thing that still remains are unmet needs in the disease landscape for wet AMD [age-related macular degeneration] and diabetic macular edema. One of those unmet needs is improving the representation in the equity of patients in clinical trials. We have a phase 4 study called ELEVATUM, looking at faricimab in a minority population—specifically Black and brown patients—which is a wonderful thing to do. I’d like to see more representation across disease states in all clinical trials. I like that ELEVATUM is pointed, especially toward that. In addition to improving equity and getting a data set in patients that matches the actual real-world population, what do you think we need to do to meet more of these unmet needs and close these care gaps in common retinal disease? The sky’s the limit. What would you like to see?
Caroline Baumal, MD: I want to find the right balance between seeing my patients, monitoring, and doing the injection safely but seeing patients less frequently. If an agent lasted 3 to 4 months, that would be ideal. I still want to see my patients. I want to check their retina. I want to make sure they don’t have any other coexisting diseases. I feel that it’s important to match the examination with the injection. It’s important to maybe have home OCT [optical coherence tomography] to monitor them in the time that we’re not seeing them or some home monitoring, but it’s important to see the patients. I’m not sure seeing them once a year would be too long for me.
The other thing I hope that we get from the ELEVATUM study is something you mentioned before. Looking at the patients who don’t have the systemic parameters to meet clinical trial criteria or patients who can’t come in every month to be in a clinical study, how are these patients in the real world going to do? We look at all these real-world data. We know they don’t meet the clinical study data. Maybe we’ll have a better idea about why that difference is.
David A. Eichenbaum, MD, FASRS: I tend to agree with you regarding the time aspect of following your patients. Even if we had a long-lasting agent—let’s say a once-a-year agent—it’s nice to see your patients. It preserves a good relationship with them and ensures the opportunity to make sure the patients have buy-in to their ocular disease. If it’s diabetes, [they can buy-in] to the manifestation of their systemic disease. In the short term, my wish is to see ELEVATUM teach us about the underrepresented population. The disease parameters for the population allowed into ELEVATUM are more liberal than what we saw in the phase 3 clinical trials for faricimab.
Outside faricimab, a treatment that improves not only durability but also efficacy would be great. We’re probably still leaving some vision on the table, especially with patients who present with more advanced wet macular degeneration with some fibrin or some subretinal hemorrhage. I’d like to see an agent that’s not just a durability play but an efficacy play. We have some of those agents in the pipeline in clinical development, and there’s a lot of excitement for things like gene therapy, things we can do with the port-delivery system. We must remember that we’re competing with all these novel delivery techniques with extremely safe intravitreal injections. We can’t sacrifice safety. If we’re getting good durability from intravitreal injections, for something that may require somewhat less treatment but compromise the outstanding safety results we see with intravitreal injections, the dream agent would be just as safe as the stuff we’ve been using for years. It would last forever, and it would do better from an efficacy standpoint. An agent that meets all those criteria probably isn’t in the pipeline. But pie in the sky, that’s what we’d like to see. We’d like to see those data in a population that mirrors the population of the United States.
Caroline Baumal, MD: David, this has been a big year. We’ve had some new agents, we’ve had some biosimilars approved, we’ve had more things than we’ve had in the last few years, but I see it all as positive. I see it all as a way to drive more innovation, to do what you’re saying: get more longevity, to drive companies and investigators and scientists to find ways to get more vision. Diagnosing disease earlier, maybe even treat earlier, just push us to the next step in retina.
Transcript edited for clarity
