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Yesterday, the drug EYLEA (aflibercept), an anti-vascular endothelial growth factor (VEGF) antibody, was approved by the FDA to treat macular edema associated with central retinal vein occlusion (CRVO).
A central retinal vein occlusion results when the main vein that drains blood from the retina gets blocked by a blood clot and blood backs up inside the retina — leading to hemorrhages and tortuous blood vessels.
If old blood cannot get out of the eye, then new blood cannot get into the eye and the retina becomes starved for oxygen. This state of hypoxia and ischemia leads to increased expression of VEGF. One of the actions of VEGF is to cause leakage of fluid from capillaries and the consequent macular edema (swelling of the retina) in CRVO.
Macular edema is the principal cause of vision loss in CRVO
EYLEA (Regeneron, NASDAQ: REGN), and other anti-VEGF medications, Lucentis (ranibizumab) and Avastin (bevacizumab) (Genetech, NYSE: DNA), reduce macular edema by acting as antibodies (or antagonists) to the VEGF molecule. In essence, EYLEA, Lucentis, and Avastin block the action of the circulating VEGF molecules in the eye, reducing macular edema and preventing vision loss.
In their press release, Regeneron reports that a 2 mg injection of EYLEA in the eye every 4 weeks has been approved by the FDA to treat macular edema in CRVO. This came after review of two pivotal Phase III clinical trials, COPERNICUS and GALILEO, that enrolled 358 patients from multiple sites throughout the world. 56-60% of patients who received EYLEA gained at least 3 lines of vision (that’s a doubling of the visual angle on the eye chart), compared to 12-22% of patients who received a sham injection. EYLEA was not compared head-to-head with other anti-VEGF medications like Lucentis and Avastin, so we have no scientific data to support if one is better or safer than the other.
What this means
For us retina specialists out there, the approval of EYLEA gives us another weapon for the treatment of macular edema in CRVO. Given it’s higher binding affinity for VEGF than Lucentis and Avastin, EYLEA may help our patients with edema that does not respond well to the other drugs. Some may also choose it as a first line agent.
How will you use EYLEA in your practice?
(Disclosure: In the past year, I have served as an educational consultant to Regeneron. I have no financial relationship to Genentech.)