Practical and Clinical Implications for a Rapidly Changing Treatment Landscape in DME and AMD


Retina specialists discuss concerns and apprehensions that both physicians and patients may feel towards newer modalities and delivery mechanisms for the treatment of AMD and DME.

Carl D. Regillo, MD, FACS: Mike, can you tell us your thoughts on how these newer therapeutic approaches—faricimab, the Port Delivery System—are going to affect patient outcomes?

Michael A. Klufas, MD: It’s great to have more treatment options. Seven years ago we had 2 or 3 treatment options. Now, for neovascular age-related macular degeneration [AMD] and diabetic macular edema, if you include clinical trials, you may have up to 10 treatment options to offer your patients. Faricimab (Vabysmo) and the Port Delivery System [PDS] or ranibizumab (Susvimo) are contributing to those options. Faricimab or Vabysmo and ranibizumab have come out around the same time, so it’s an interesting time to offer both to patients and see which option they may choose. In reality most of us are accustomed to the injection process, so integrating Vabysmo or faricimab into your clinical practice is quite easy. The Port Delivery System, or Susvimo—this is a paradigm shift and involves some training and a little bit of activation energy to offer this to our patients. For the right patient, it’s a great treatment option. I’ve heard many people say we’ll try faricimab first, and if that doesn’t work, we will go on to the Port Delivery System. In my mind, there are different types of patients, and I try to ascertain what patient may be an ideal candidate when discussing these options, because you can’t discuss everything with every single patient, and it could be quite confusing to our patient population as well. But all in all, if they are doing well on the current therapy, I will say, Hey, there is something new that may be coming out; I am considering this in the next couple of months. Here is some information, and we will make a decision in the future.

Carl D. Regillo, MD, FACS:Do you think we’re going to get better vision outcomes with these more durable approaches?

Michael A. Klufas, MD: A lot of these trials had a 1-year primary end point, and if we are thinking that we might have superiority of 1 to 3 letters per year, it’s going to take a couple of years to show that. In theory, especially with previous trials, they have shown more frequent treatment has yielded better outcomes by a couple of letters. If we follow these more continuous therapies over time, there is a potential to show that, and that would be a real advance for our patients. It’s something else to consider when offering these more durable or continuous therapies as well.

Carl D. Regillo, MD, FACS: I’m hopeful. I think it means less disease recurrence and better long-term maintenance of those vision gains we get up-front, rather than losing them as in the real world, which is typically what those studies show.

Blake, we have these new therapies. Have you encountered any apprehension or misunderstanding related to these new therapies as you’ve now started to think about them in practice or offer them to your patients?

Blake Anthony Cooper, MD, MPH: We can think about it as apprehension among physicians and then apprehension among our patients. If we drill down into some of the trial results, there is an apprehension for the risk of endophthalmitis, and it’s still a relatively low number of individuals that have had the Port Delivery System. When it comes to the risk for infection and the black box warning—at least within the retina community that I am exposed to—there is still a real concern for that risk of infection. As we continue to evolve techniques and more patients are undergoing the procedure, I think that we will be more comfortable, and I am hopeful that the endophthalmitis rate will be reduced. There is also concern about reimbursement. It’s difficult to have a surgery center or location where you can do the surgery and have reimbursement for it. Until those hurdles are lowered, we may not see the numbers that we are possibly expecting. I also think that among the patients that are currently doing well with standard of care, it’s often hard for them to want to change. I think they become dependent on coming in and seeing us and realizing that they are doing well. Oftentimes my patients are evaluating their images as much as I am, and they are discerning if they are having any increase in retinal edema. They get quite good at reading those images. They like the experience of knowing they are doing well and the reassurance of the current medications, because it is important to stress that the therapies we have are exceptionally good at helping stabilize disease processes and continue maintaining that visual improvement. As far as the next area of education, it’s important to be up-front with patients that it’s not just 1-and-done therapy. It’s important for those who have diabetes that we’re controlling their macular edema, and it is important on their end to continue to control their glucose levels. And for those with macular degeneration that we want to continue to monitor, if we're only treating 1 eye, you want to make sure that they realize that it could be a bilateral process. I really stress that.

Carl D. Regillo, MD, FACS: I’m glad you put it as apprehension broken down into among doctors versus among patients. That’s spot on. The doctor has different concerns sometimes compared with the patient. The patient as you said, is often hesitant to make a change if they are doing OK. But it’s probably going to be an easier transition to think about going from an older anti-VEGF to faricimab because that’s not as big of a change, but to go to the Port Delivery System, a patient might say, sign me up, but may not have a full understanding of all the issues involved in the potential new types of adverse events associated with them; the doctor may be perhaps a bit reluctant to offer that change. You’re right, it’s a combination of patients and doctors considering all the pros and cons, and we might have different ideas. You need to get on the same page and have a good understanding. It’s going to take a lot of effort and a lot of time in speaking to patients about making a change, especially if it means something truly different like PDS and going to the operating room.

Transcript Edited for Clarity

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