September 21, 2012 — The US Food and Drug Administration (FDA) has approved aflibercept injection (Eylea, Regeneron Pharmaceuticals) for treating macular edema following central retinal vein occlusion (CRVO), the manufacturer announced today.
The decision expands the use of aflibercept injection, which won FDA approval in November 2011 for neovascular (wet) age-related macular degeneration In August, the agency greenlighted another form of aflibercept (Zaltrap, Regeneron/Sanofi) for metastatic colorectal cancer.
An angiogenesis inhibitor, aflibercept neutralizes vascular endothelial growth factor (VEGF) types A and B and placental growth factor, and therefore acts more broadly than other antiangiogenic agents such as bevacizumab (Avastin, Genentech).
The FDA approved aflibercept injection for macular edema following CRVO on the basis of the phase 3 COPERNICUS and GALILEO studies. Patients treated with aflibercept experienced a higher degree of improved sight at 24 weeks compared with a sham control group.
The recommended dose is 2 mg by intravitreal injection every 4 weeks. Patients should report any symptoms suggesting endophthalmitis or retinal detachment — complications of intravitreal injections in general — without delay. Aflibercept and other intravitreal VEGF inhibitors come with a potential risk for arterial thromboembolic events, according to Regeneron.
Aflibercept is contraindicated for individuals with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to the agent or its excipients.
The most common adverse reactions are eye pain, conjunctival hemorrhage, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.
More information about the expanded indication for aflibercept is available on Regeneron’s Web site