Key opinion leaders emphasize important considerations when discussing the safety of anti-VEGF agents with patients and highlight unmet needs in nonproliferative diabetic retinopathy treatments.
W. Lloyd Clark, MD: Let’s shift gears for a few minutes to talk about safety. This came up earlier, we’ve been incredibly fortunate to have 2 agents come to us, in a fairly quick period of time, that have been incredibly effective and very safe for our patients, then stood the test of time for 15 years or so. Diana, are there specific considerations for your patients with diabetes as it pertains to safety? Are there factors that you discuss with them? Or do you approach them in a way similar to patients who need anti-VEGF therapy for other indications?
Diana V. Do, MD: We’ve learned over the past decade that interatrial VEGF inhibitors, such as aflibercept and ranibizumab, are extremely safe and effective. We’ve seen that across patient populations, whether it’s patients with diabetes, elderly patients with wet age-related macular degeneration [AMD], or patients with retinal vein occlusion, that the safety profile is consistent across these populations. I’m confident in recommending these treatments for patients with diabetic eye disease.
W. Lloyd Clark, MD: Let’s look forward into the future. There are a number of different agents for a variety of indications. We have biosimilars coming to the market. What’s going to be most important for you as you consider new therapeutic options in this space? Is it going to be the idea that we’re going to see dramatic improvements in efficacy? Or has safety suddenly become the No. 1 issue, given some of our recent experiences with new agents?
Joseph M. Coney, MD: I must say this has been a disappointing part of our field. We’ve had previous biologics that we looked at that were very efficacious, and because of the rates of inflammation, they did not get approved. It seems as though as we progress in our field, and we have longer-acting agents, this is something that has been a recurring thing. I’m hoping going forward our pipeline is pretty robust. We talked about the KIS-301 antibody biopolymer conjugate earlier today. We may have a PDS [port delivery system] that may be beneficial. There are other agents that may have great efficacy, and they may be a little bit more tolerable to the eye. The studies are ongoing, the preliminary data look good. If we can get the efficacy piece, and to decrease patient burden, to not have the inflammatory piece, that’s really great. It also may be true that it’s about time that we started having these discussions with patients about being comfortable with adverse effects. It’s amazing how cancer physicians prescribe all sorts of medicines, people lose their hair, they get ulcers, all these issues, and if they extend your life for 6 months, it’s a success. But we, as ophthalmologists, don’t like talking about intraocular pressure. We don’t like talking about cataracts. These are reversible, these are things that are treatable. If we’re going to try to maximize the efficacy in our patients by decreasing the unmet need, which is burden, we may have to start talking about some of the adverse effects that we often treat.
W. Lloyd Clark, MD: Joe mentioned future agents KSI-301 and the PDS implant. The common thread with those 2 is that they appear to offer the opportunity for significant reductions in treatment burden with perhaps the same clinical efficacy as monthly injections of anti-VEGF therapy. It’s all the good that we get with progressive therapy with reduced treatment burden. That’s obviously an important unmet need in our space. What else would you identify as an unmet need? Or where should we move going forward to push the ball forward in terms of treating our patients?
Ehsan Rahimy, MD: Longer term, our goals are obviously to improve efficacy. We care about vision at the end of the day. And ideally, we’d like a few therapeutic targets that we can potentially pair with our VEGF inhibitors to get improved visual acuity gains; reduced treatment burden obviously is a big thing. As far as what’s immediately on the horizon, as you alluded to, is going to be improving durability, reducing treatment burden while maintaining the same degree of vision gains. That being said, we’ve all experienced this in the last year, safety trumps everything now. That pendulum has swung to that extreme due to what we saw with brolucizumab. We saw what happened with abicipar as well. Biosimilars are right around the horizon. There are some potential theoretical and well-founded concerns about their safety in terms of the purification process of how these antibodies are made. Safety is the primary concern now. After that, hopefully, some of these new, longer-duration treatments are going to allow us to reduce injection burden. And deeper into the pipeline, when we look at some of the newer therapeutic targets, we’ll be able to even potentially improve vision further, or at least address some of these parts of the disease process, AMD atrophy for example, where we don’t have any treatment at all.
W. Lloyd Clark, MD: And Diana, how about you? What’s the future look like for us as retinal physicians, and for our patients in managing retinal disease? What do we need to take better care of our patients?
Diana V. Do, MD: The future is very optimistic and bright because of new agents that are likely going to meet the burden of treatment and reduce the frequency of injections. Having the discussion of treating diabetic retinopathy when there is no vision loss yet, being more proactive, is going to be important. Because, as retina specialists, we do have approved agents that are safe and that can turn back the hands of time and decrease the risk of vision-threatening complications. There is going to be a paradigm shift in the future, and having these discussions will help facilitate that.
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