A new study, published “online first” on May 23, 2013 in the American Journal of Ophthalmology, concludes that Eylea therapy appears to be beneficial in a specific group of patients with wet age-related macular degeneration (AMD) whose symptoms are not responsive to either Lucentis or Avastin injections. The American Journal of Ophthalmology is a peer-reviewed, scientific journal that has been published monthly since 1884. The Journal publishes original research directed to ophthalmologists and visual science specialists that “describes clinical investigations, clinical observations, and clinically relevant laboratory investigations.”
About the Research
The study, entitled Aflibercept [Eylea] Therapy for Exudative [Wet] Age-related Macular Degeneration Resistant to Bevacizumab [Avastin] and Ranibizumab [Lucentis], was authored by Benjamin Bakall; James C. Folk; H. Culver Boldt; Elliott H. Sohn; Edwin M. Stone; Stephen R. Russell; and Vinit B. Mahajan, who represent the University of Iowa Carver College of Medicine.
Here is more information about the study, excerpted from the article abstract:
Purpose: To evaluate the outcome of intravitreal injection of [Eylea] in cases with exudative [wet] age-related macular degeneration (AMD), resistant to injections of bevacizumab [Avastin] or ranibizumab [Lucentis].
Methods: A retrospective chart review [i.e., collecting data from past records] … was conducted to identify patients with exudative [wet] AMD and choroidal neovascularization in one or both eyes resistant to treatment with [Lucentis] and [Avastin] who were switched to treatment with at least three monthly injections of [Eylea]. In total, 36 eyes from 31 patients were included.
Results: The mean patient age was 79 years (range 60-88). There were 13 male and 18 female patients. The number of prior injections with either [Avastin] or [Lucentis] ranged from 6-74. After three monthly injections of [Eylea], there was a reduction of either subretinal or intraretinal fluid in 18 of 36 (50.0%) of the treated eyes; the amount of fluid remained stable in 15 eyes (41.7%) and worsened in three eyes (8.3%).
About Age-Related Macular Degeneration (AMD)
In wet macular degeneration, the choroid (a part of the eye containing blood vessels that nourish the retina) begins to sprout abnormal vessels that develop into a cluster under the macula (called choroidal neovascularization).
The macula is the part of the retina that provides the clearest central vision. Because these new blood vessels are abnormal, they tend to break, bleed, and leak fluid under the macula, causing it to lift up and pull away from its base. This damages the fragile photoreceptor cells, which sense and receive light, resulting in a rapid and severe loss of central vision.
Eylea, Lucentis, Avastin, and Anti-Angiogenic Drugs
Angiogenesis is a term used to describe the growth of new blood vessels and plays a crucial role in the normal development of body organs and tissue. Sometimes, however, excessive and abnormal blood vessel development can occur in diseases such as cancer (tumor growth) and AMD (retinal and macular bleeding).
Substances that stop the growth of these excessive blood vessels are called anti-angiogenic (anti=against; angio=vessel; genic=development), and anti-neovascular (anti=against; neo=new; vascular=blood vessels).
The focus of current anti-angiogenic drug treatments for wet AMD is to reduce the level of a particular protein (vascular endothelial growth factor, or VEGF) that stimulates abnormal blood vessel growth in the retina and macula; thus, these drugs, including Lucentis, Avastin, and Eylea, are classified as anti-VEGF treatments. These drugs are administered by injection directly into the eye after the surface has been numbed. (Note: Avastin is a drug that is FDA-approved since 2004 for intravenous use in colorectal cancer. It is used on an “off-label” basis [i.e., via eye injection] to treat wet AMD.)
At present, these anti-VEGF drugs require monthly injections or a pro re nata [i.e., “as needed”] (PRN) regimen, with monthly controls and injections for recurrent or persistent macular bleeding.
More about the Study
From a study summary in Science Codex, entitled Research shows new drug could help people with AMD:
…for some AMD patients, [Lucentis and Avastin] either don’t work for long or fail to work at all. It’s a dead end for treatment, or so it seemed.
Now, a team of ophthalmologists at the University of Iowa (UI) has shown that a third drug, Eylea, can ease leaking and vision problems for wet AMD patients. In a study involving 31 AMD patients at the UI Hospitals and Clinics, researchers report that half of the eyes treated with Eylea had reduced fluid after three monthly injections. Moreover, in some cases subsequent bimonthly injections with Eylea were deemed as effective as monthly injections of Avastin and Lucentis over a similar time period, meaning fewer visits by patients and less cost.
“The challenge has been treating patients who are not very responsive to the first two drugs (Avastin and Lucentis). It was assumed that they would not respond to anything,” says Vinit Mahajan, assistant professor in the Department of Ophthalmology and Visual Sciences at the UI and the corresponding [study] author. We are among the first to show that this drug can be effective in patients that were resistant to the first two drugs.”
The patients who tried out Eylea were 79 years old on average. All had undergone eye injections with Avastin and Lucentis, some dozens of times. After three monthly injections of Eylea, half of the eyes treated (18) had less fluid in or around the retina. One in five of those patients also had improved vision after the initial rounds of treatment, according to the researchers, and nearly one in three had improved vision after six months of treatment.
The UI study was a pilot, designed to test Eylea’s effectiveness in a small cohort for six months. Dr. Mahajan is quick to point out further studies are needed to fully evaluate the new drug’s efficacy, and he would like to see a trial directly comparing the drugs. Until then, there is another option for [people with AMD].
VisionAware will continue to provide updates for this ongoing macular degeneration research as they become available.