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The FDA has approved aflibercept for the treatment of neovascular age-related macular degeneration.
Tarrytown, NY-The FDA has approved aflibercept (Eylea, also known as VEGF Trap-Eye, Regeneron Pharmaceuticals) for the treatment of neovascular age-related macular degeneration (AMD). The recommended dose of the drug for wet AMD is 2 mg every 4 weeks for the first 12 weeks and then 2 mg every 8 weeks.
The importance of the drug to this patient population is that not only is the efficacy of aflibercept equal to that achieved with the current gold standard anti-vascular endothelial growth factor (VEGF) drug, ranibizumab (Lucentis, Genentech), but, more importantly, the patients' treatment burden is reduced, noted Peter K. Kaiser, MD, a principal investigator in the VEGF Trap-Eye studies, and a vitreoretinal specialist at the Cole Eye Institute, Cleveland Clinic, Cleveland.
Regeneron announced the FDA decision in a prepared statement on Nov. 18, 2011.
Aflibercept is a recombinant fusion protein that works as a soluble decoy receptor that binds all isoforms of VEGF as well as placental growth factor. By so doing, the drug inhibits the activation of the VEGF family of receptors by their ligands.
"Overall, this is a very positive step in the right direction for everyone involved in the management of AMD," Dr. Kaiser said.
The FDA moved to approve aflibercept under a priority review, which the prepared statement described as a "designation that is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. This approval was based upon the results of two phase III clinical studies."
The patients who participated in these studies received aflibercept every 8 weeks after they had been treated with three initial monthly injections. The results with aflibercept were clinically equivalent to ranibizumab injections that are administered every 4 weeks over 52 weeks.
The adverse reactions that are associated with aflibercept are subconjunctival hemorrhages, ocular pain, development of cataract, vitreous detachment, vitreous floaters, and increased IOP-all of which are similar to the adverse events with ranibizumab. The drug also carries a potential risk of the occurrence of arterial thromboembolic events following use of intravitreal VEGF inhibitors (i.e., nonfatal stroke, nonfatal myocardial infarction, or vascular death, including deaths of unknown cause). The incidence of arterial thromboembolic events with the product in the clinical trials was low (1.8%), according to the manufacturer, which also noted that "serious adverse reactions related to the injection procedure have occurred in less than 0.1% of intravitreal injections with [aflibercept]." These include endophthalmitis, traumatic cataract, and increased IOP. These values were similar to those seen with ranibizumab in the study.