PUBLICATION EXCLUSIVE: New options under study, but for now anti-VEGF monotherapy remains gold standard for wet AMD
Anti-VEGF-A therapy will never completely go away for the treatment of neovascular age-related macular degeneration, but new therapies that improve the efficacy and durability of treatment are needed to help bridge the results between clinical data and real-life results for patients.
VEGF-A suppression will not be abandoned, but researchers and ophthalmologists need to find a new way to increase efficacy and the durability of treatment to better serve patients diagnosed with wet AMD, OSN Retina/Vitreous Board Member Pravin U. Dugel, MD, said.
“I do think it’s important to recognize that VEGF-A suppression will never go away. It will always be the crux of our treatment strategy. If the Ophthotech study and the Regeneron study teach us anything, they teach us what a very high hurdle we must overcome to do better than anti-VEGF-A monotherapy. ... I think there is great opportunity to add on another agent for combination therapy that will either get us a greater durability or greater efficacy, and either of those two, but particularly both of those two, will help us close the delta,” Dugel said.
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Image: Dugel PU
A treatment delta exists
The gap between real-world results and pristine clinical data has never been larger than it is now, Dugel said.
When there is such a difference between how patients are treated in a trial and how patients are actually treated in the real world, the treatment gap becomes “bigger and bigger, and that is a dangerous sign for our community and in our field,” Dugel said.
The delta exists in two “silos,” Dugel said, a logistical silo and a physiological silo.
Clinical trials, for instance, suggest patients diagnosed with wet AMD should be given an anti-VEGF-A drug once a month, or every 4 weeks.
“In real life, and we know this in the U.S. from the Medicare database, we are actually treating approximately half as frequently as we should. We know also that as the years go on, the number of injections become less and less and less frequent. This happens for many reasons. Patients drop off, the treatment is not sustainable, and the logistic delta is enormous. We know that for a fact based on real-life data. Almost all the clinical trials are based on a treatment plan that is simply not sustainable,” he said.
The second silo is physiological, Dugel said. When patients are first diagnosed with wet AMD and started on a treatment, they typically have another 15 to 20 years to live.
“But think about this. There is not a single study that I know of that goes past 4 years with anti-VEGF-A monotherapy that improved the patient’s vision above their original baseline. Just think about that. It’s not that the 4 years is not valuable — it certainly is, and anti-VEGF-A monotherapy has changed many, many lives, hundreds of thousands of lives — but it’s important to also understand the limitations. After 4 years, it appears that patients end up where they had begun because vision gradually deteriorates. Patients have many more years to live after that,” he said.
• Click here to read the full publication exclusive, Cover Story, published in Ocular Surgery News U.S. Edition, February 25, 2017.