Anti-VEGF and Gene Therapy Impacting Wet AMD and DME Treatment Landscapes

Dr Sheth discusses his insights on anti-VEGF therapy that he has noticed in the treatment of wet AMD over the last decade, and Caesar Luo, MD, FASRS, FACS shares his insight on new treatment options and their impact on patient access and cost considerations.

Jim Kenney, RPh, MBA:Dr Coney, a question for you. As Dr Luo mentioned, the anti-VEGF [vascular endothelial growth factor] agents came out around 2006. Within the last year, there have been a number of new treatment options added to the clinician’s armamentarium. How will the addition of the new agents to this class impact the overall treatment landscape of wet AMD [age-related macular degeneration?

Joseph Coney, MD, FASRS, FACS: Jim, I think that’s an excellent question. The landscape has really changed in 2006. I remember when I was training; we really didn’t have great trials. I started training in 2006, so I actually launched with the first biologic treatment for wet macular degeneration. I remember before then not having good options for patients and patients just losing more and more vision. The first time I saw the data on these medications, it really was eye-opening. I think all of us have found drastic ways to improve an individual’s quality of life and even stabilized the diseases over the past 15 years. With that being said, all the early registry trials looked at fixed and frequent dosing and these individuals had intensive therapy in these trials for up to 8 weeks. We found that those individuals had really good efficacious vision gains. They were maintained for 2 and sometimes 3 years. As this became on-label dosing, we were able to make significant…strides. Over time we tried different things. We tried PRN [pro re nata] dosing, for example, through the PRONTO trial, and we found that the PRN dosing didn’t do as well as those that had frequent dosing because it’s very hard to have those patients come in because they had to be monitored quite frequently, which is very difficult. In our more recent trials, I think that what it gives us is the ability to maybe customize or individualize therapy. Before we had fixed dosing that went up to 8 weeks. Now we’re seeing medications that we can customize from every 4 weeks to actually up to 16 weeks depending on the different biologics. I think the things that we’re developing, as Dr Luo talked about, are actually increasing the durability of our drugs where individuals may not have as many frequent injections in order to keep those eyes more stable.

Jim Kenney, RPh, MBA: Thank you. Dr Sheth, anything else we’ve learned about using anti-VEGF agents for the treatment of wet AMD over the past decade?

Veeral Sheth, MD, MBA, FACS, FASRS: There are a couple of things. I think the biggest thing we learned is that anti-VEGFs are extremely effective. I think the study that Dr Coney is citing from 2006 set the bar very high. After 10, 15 years of research and development, we have still not found anything better than those initial anti-VEGFs, so I think we’ve been fortunate that those early findings for us were really quite groundbreaking, and many, many patients have benefited from that. I think that’s one thing we’ve learned. I think the second thing we’ve learned is that with these treatments, the more frequently you treat a patient, generally, the better they do. I think if you take the flip side of that, what we’re really looking for now are treatments that last longer so we can pull back and we can say, hey, instead of treating this patient every month or 2, I would love to be able to treat them every 3 or 4 months. I think we’re starting to finally find our footing in that area where we’re starting to see treatments come through that are more durable, that are lasting longer without sacrificing those vision gains that we’re getting early on in treatments. I think we’ve learned. Again, we’ve set the bar high. It’s hard to beat that, but we’re finding ways now to kind of get moved beyond these frequent therapies.

Jim Kenney, RPh, MBA: That’s certainly something from a payer perspective that we’ve been hoping for, that we would be able to see an extended dosing interval, which lowers the cost. On that note, Dr Luo, how do these additional treatment options for wet AMD impact the treatment access but also the cost considerations?

Caesar Luo, MD, FASRS, FACS: It’s a tricky landscape. It is an exciting time for us because, again, we have an expanded armamentarium that we can offer our patients. We know the data as well with Avastin, or bevacizumab. As we know this is non–FDA [the US Food and Drug Administration]-approved medication that many payers actually insist that we use first as part of step therapy. I see the reasons for that. I think that it is such a low-cost medication, and if we’re looking at the other side of the coin, besides effective durable therapies, some of these patients are uninsured that we see. Sometimes, patients have a lot of difficulties being able to get to the office. How do we provide them with the most optimal care? I think one of the new things that have crept up that’s an interesting conversation for us potentially today is biosimilars, which might be able to position themselves as a relatively durable therapy [that’s] FDA approved and might be a lower-cost alternative for treatment therapy. Our gold standard, and [what] I think what we should continue to strive for as a community, is durable effective therapies. The flip side of that is being able to offer that to everyone. Some of these newer therapies might make it difficult in terms of access to care, especially if they don’t have the right insurance or have no insurance. These are certainly considerations that we have to have as a community.

Transcript edited for clarity.

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