Drs David A. Eichenbaum and Caroline Baumal discuss implications of the treat-and-extend approach with faricimab in patients with wet AMD.
David A. Eichenbaum, MD, FASRS: You mentioned clinical trials. We have a new data set of phase 3 clinical trials in macular degeneration for injectable therapies that just came out, with 2-year results over the past 6 to 12 months. If we look at those trials, 60% of patients in the clinical trial population, which was a completely treatment-naïve population in TENAYA and LUCERNE, could be treated out to every 16 weeks. About 80% of the patients could be treated at every 12 weeks or longer, decreasing the number of injections to 10 compared with 15, with those treated with aflibercept if you look over the course of those 2 years. That’s a significant reduction in burden. Granted, the aflibercept wasn’t given the same optionality for extension in the first or second year of TENAYA and LUCERNE, but this is the first study that has showed noninferiority to every-8-week aflibercept, which is an outstanding gold standard regimen with significantly longer intervals and a significantly reduced mean number of injections. What does that mean to you in a clinical practice, Caroline? How do you translate that into something that’s meaningful for patients who are having nonclinical conversations or nonscientific conversations with us, now that you know what the 2-year data for TENAYA and LUCERNE look like?
Caroline Baumal, MD: I’m really excited for this data set. The study design was very thoughtful. In the study design, patients in the faricimab arm received 4 monthly loading-dose injections. Patients were stratified based on disease activity assessments at weeks 20 and 24. Based on how they looked at that time, they were treated every 8, 12, or 16 weeks. This study identifies patients who need to have more frequent treatment. If you had disease activity at week 20, you were treated every 8 weeks. You were identified as someone who’s going to need more injections. If you didn’t have disease activity at weeks 20 and 24, you were in every-16-week arm. I thought that was very smart to do that.
At week 60, when all the first amounts of arms meet up, that’s when patients went into a PTI, a personalized treatment interval, until week 112. That makes sense because it identified the people who need more frequent treatment for the first 60 weeks. After that, they went into more treatment, a more protocol-driven treat and extend, which is probably similar to what many people do in the real-world practice. Looking at the faricimab arms, I’m very encouraged that the median number of injections was less. If we can tell our patients, based on how they respond in the beginning, where they might fall after 2 years, that will be positive encouragement for our patients.
Transcript edited for clarity