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Better monitoring, delivery systems needed for anti-VEGFs
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I do not personally perform intravitreal anti-VEGF injections, but I have many patients, friends and family members of friends who are being or have been treated. I have also taken the time to read the considerable literature in the field and have personally participated in many corporate medical advisory boards discussing the topic. So, I am no expert, but I have a few thoughts.
Intravitreal anti-VEGF injections for wet or exudative age-related macular degeneration are a truly disruptive, unexpected and amazing advance in our treatment of AMD. In the FDA studies, those patients who received monthly examinations and injections achieved amazing outcomes, especially when caught in the earliest stages of the disease. We are still learning how many eventually advance to untreatable geographic atrophy after years of injections as an end result, but restoration and preservation of vision in the early years with 100% compliance to monthly injections have been extremely good.
Unfortunately, in the real world, only about one in three of my patients, friends and family of friends can sustain the treatment regimen, and this number seems universal. The significant time commitment required by the patient and family, the meaningful cost and the mild pain associated with the injections cause many patients to tire of and eventually decline monthly injections. The so-called “real-world” outcomes reported in the literature and at meetings are far inferior to the early company studies, mainly because of poor compliance with a significant decrease in the frequency of injections.
It takes most patients three monthly injections to get a good response. The frequency of treatment required after that is different for each patient, and that has led to the so-called “treat-and-extend” approach, which can be customized for each patient. The challenge is that patients still ideally need a macular OCT and a good fundus examination on a monthly basis to determine whether or not an injection is indicated.
We comprehensive ophthalmologists and our optometric colleagues can help with some patients who live in rural environments to reduce the travel burden on family and friends, but many patients live far from any provider, and even monthly examinations closer to home are a meaningful burden. The Notal Vision ForeseeHome screening device using preferential hyperacuity perimetry to screen for recurrences of wet AMD is promising and will allow some patients to monitor themselves, as would a home OCT, which is in development.
We have the safe, effective and disruptive treatment for wet AMD, anti-VEGF placed intravitreally, but now we also need a cost- and time-efficient disruptive care delivery system. Extended-release drugs are an exciting option to reduce the patient and physician burden, but I suspect patients on extended-release drugs will still need careful examination at least every 3 months. If we are going to see patients every 3 months for a clinical examination, an extended-release drug with a 3-month duration would to me represent an adequate advance in therapy. It may not be necessary to develop extended-release anti-VEGF products with 1 or more years’ release of drug. Three months looks like a good initial target to me.
It is especially sad when we have a safe and effective treatment regimen to have it sabotaged by an inadequate care delivery system or poor patient compliance. Of course, this is common to us clinicians and familiar to every comprehensive ophthalmologist who treats glaucoma. However, in glaucoma, we can offer the noncompliant patient with progressive nerve damage a laser or surgical alternative. We need a similar procedural option for the patient with wet AMD, and one or another extended-release drug delivery system may provide it. It is always rewarding to develop the next slightly more effective drug, but I believe what we need most today in the anti-VEGF field is a better way to monitor our patients close to home and a better delivery system for our current drugs, which are already quite safe and effective.
Disclosure: Lindstrom reports he is a consultant for Novartis, Notal Vision and Ocular Therapeutix.