Jonathan Jonisch, MD

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Something that’s coming up here pretty imminently, I believe the FDA has a PDUFA [Prescription Drug User Fee Act] date for high-dose aflibercept sometime next month. Jon, you want to lead us through the PULSAR and PHOTON [trials]? What were the high-level points here, and are you having this discussion with patients?

We’re all familiar with 2 mg of aflibercept, and Regeneron [Pharmaceuticals Inc] is now testing 4 times that dose, 8 mg, across patients with DME [diabetic macular edema] and wet AMD [age-related macular degeneration]. Similar to faricimab, we have almost exceeded our expectations in terms of the durability. You start talking about well into the upper 80% [level], approaching 90% of patients who are able to get out to 3 months, and a significant number of patients able to get out to 4 months in a fairly short amount of time. It [usually] takes a while to get out to 4 months. To be able to do that in year 1, and then an even a higher percentage in the second year, I think is eliciting excitement within our community.

The idea of really bending that curve, most of us were talking about 7 or 8 weeks, if that could start going above 12 weeks, that [would be] a monumental shift. We know a lot of the disease won’t allow for that, but again, I think Ali made a great point, a patient segment that we really don’t spend a lot of time at our meetings talking about are the boring patients who are at 8 weeks. No one talks about them. Some of these newer medicines, it’s going to be interesting to see how much they can give those guys a boost to go to potentially 3 or 4 months, 10 weeks, 12 weeks, maybe 16 weeks from that point they’ve been stuck at, 8 or 9 weeks. Again, it’s going to be hopefully in our armamentarium sometime in the middle of the year. My patients, some of them ask, “What other options am I going to have?” So for some suboptimal responders, raising the dose is going to be beneficial for them.

We touched base earlier on when these newer medications come out, how do you have these conversations with patients about potentially introducing something new? I assume we’re all preliminarily having these discussions around high-dose aflibercept. Do you find that this conversation perhaps goes a little easier, Veeral?

For sure with the high-dose aflibercept, because it’s easy to tell a patient, “Hey, I’m going to give you the same drug, just a little more of it.” I think definitely a difficult conversation, or more difficult sometimes with faricimab, is when you’re talking about new mechanisms of action, and the real question is, do you even go into that part of the conversation? But I think at all these time points, I’m always mentioning when I’m switching a patient [that] this is progress. If I were treating you the same way I did 10 years ago, something’s wrong. I think at the end of the day, I frame it in the context of progress. And when I’m making that switch, presumably to faricimab, or high-dose aflibercept, or whatever comes next, that’s how I frame it.

Yes, it’s an interesting conversation because in other parts of medicine, it’s not really considered a switch. If a patient comes in, they’re on cholesterol medicine, blood pressure medicine, and the numbers aren’t great, they sometimes raise the dose. They’re not switching classes [from a] beta-blocker to a calcium channel blocker. So raising the dose, although it’s a different medicine and almost is going to be a separate brand for the manufacturer, there’s definitely less resistance. It’s a more seamless talk. Patients are going to get [that], as opposed to [when we say] we’re going to switch to a whole new medicine, a lot of times patients start hearing that it may come with a whole new set of adverse effects. So from a patient reassurance point of view, there may be less resistance and more understanding. It remains to be seen.

Experts discuss the recent PULSAR and PHOTON studies with high dose aflibercept (8mg) and how they educate patients about this treatment approach. 

Jonathan Jonisch, MD

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