The Challenges of Drug Delivery for Retinal Diseases - Episode 10
Ophthalmologists highlight recent treatment advances in diabetic macular edema and wet age-related macular degeneration.
Albert J. Augustin, MD: I would like to move forward to the next topic of our conversation, the pipeline and future outlook of drug and device therapy. Let’s start with some recent advances. Dr Peto, can you comment on the Yutiq [fluocinolone acetonide] intravitreal implant?
Tunde Peto, MD: Steroids have been used in diabetic eye care and uveitis care for a very long time. What we would like to achieve is that we dampen the inflammatory component of the eye disease as well. We do know there are patients who did not respond to anti-VEGF [therapy] well, then they respond to steroids perfectly. They regain vision, their diabetic macular edema does not come back for an extended period, and they don’t necessarily need to have their injections, at least for a while. Sometimes patients still need a few rescue injections later. With the long-term implants, we’d like to achieve that you can have a stable macular edema, or the macular edema completely goes away, and there is no seesawing of the retinal thickness. Also, these drugs can be given to patients where anti-VEGF [therapy] might not be an option. As we all know, you cannot give anti-VEGF to people with strokes and heart attack for about 12 weeks; unfortunately, people with diabetes do have a lot of other comorbidities and they sometimes struggle to get their required number of injections because of them. These steroid implants can be very beneficial for those who cannot have anti-VEGF, choose not to have anti-VEGF, or if a very long term is required with the fewest number of injections that we can have.
Albert Augustin, MD: Thank you. One word on fluocinolone and IOP [intraocular pressure]?
Tunde Peto, MD: It does need to be monitored regularly. We probably do not have to be quite as worried as we were some years ago, because we have had quite a lot of people with steroid implants in between. We usually can manage the vast majority of the IOP rise that we have seen. Some patients will progress to requiring surgery, but usually with good monitoring they do not necessarily lose sight.
Albert Augustin, MD: Dr Korobelnik, would you like to say a few words about brolucizumab for the treatment of wet AMD [age-related macular degeneration]? This drug was FDA approved in 2019, and EMA [European Medicines Agency] approved in 2020.
Jean-Franҫois Korobelnik, MD: Yes. It is a very interesting situation for brolucizumab; on one hand it is extremely effective to dry the retina, and on the other hand, for visual acuity in the trials so far, it is similar to the comparator. Recently we had the results of the trials on DME [diabetic macular edema], and the retina is drying very well with brolucizumab; this is very positive on the anatomic side. We may have a drug that is more effective to dry and that may last longer. However, maybe the trials are not designed to fully explore durability. What is very interesting is that there are safety issues; once the drug was approved and available for the physicians to treat patients, we discovered some inflammatory reaction, intraocular inflammation, vitritis, and in some cases of vasculitis. Some of them are limited, some of them are severe. On one hand we have a drug that has a very strong dying effect, and on the other hand we have a drug that is exposing the patients to some risk that we are not used to. Of course, that risk is uncommon; it may be something around 5%, maybe a little more. Some countries have approved and covered the brolucizumab, some countries have not approved or not covered. That’s the situation in France at the moment: the drug is approved by the European Medicines Agency, but the French authorities refused to cover brolucizumab because the visual acuity result is the same as the comparator. It is a very interesting drug, however, we still need to understand why there is inflammation in some cases, and how do we address this inflammation so that we can use it more commonly because of its excellent drying effect?
Transcript edited for clarity.