Aflibercept a viable regimen

March 1, 2012
Cheryl Guttman Krader, BS, Pharm

Results from an integrated analysis of data from 12 months of follow-up in the two similarly designed prospective, randomized studies comparing aflibercept and ranibizumab indicate that intravitreal injection of aflibercept every 2 months is safe, predictably effective therapy for neovascular age-related macular degeneration and comparable to monthly ranibizumab 0.5 mg.

Orlando, FL-Results from an integrated analysis of data from 12 months of follow-up in the two similarly designed prospective, randomized studies comparing aflibercept (Eylea, also known as VEGF Trap-Eye; Regeneron Pharmaceuticals/Bayer HealthCare) and ranibizumab (Lucentis, Genentech) indicate that intravitreal injection of aflibercept every 2 months is safe, predictably effective therapy for neovascular age-related macular degeneration (AMD) and comparable to monthly ranibizumab 0.5 mg, said Ursula M. Schmidt-Erfurth, MD, at the annual meeting of the American Academy of Ophthalmology.

Dr. Schmidt-Erfurth presented functional, anatomic, and safety data from the Vascular Endothelial Growth Factor (VEGF) Trap–Eye: Investigation of Efficacy and Safety in Wet AMD 1 (VIEW 1) and VIEW 2 studies. She is professor and chairwoman, Department of Ophthalmology, Medical University of Vienna, Austria.

Together, the trials randomly assigned nearly 2,500 patients with active subfoveal neovascular AMD into four equal groups to receive ranibizumab 0.5 mg monthly, aflibercept 0.5 mg monthly, aflibercept 2 mg monthly, or aflibercept 2 mg every 2 months after 3 initial monthly doses.

The integrated analysis showed all aflibercept groups were noninferior to monthly ranibizumab for maintenance of visual acuity as well as with respect to the proportion of patients achieving a significant gain in ETDRS BCVA. In all study arms, about 95% of patients maintained BCVA and about one-third gained 15 or more letters from baseline. At study completion, the aflibercept 2 mg every 2 months group had the lowest central retinal thickness and the highest proportion of patients with a completely dry retina.

Aflibercept was generally well-tolerated at all doses and regimens and was not associated with any systemic safety concerns, Dr. Schmidt-Erfurth noted.

"This is the largest clinical trial ever undertaken in neovascular AMD, and the results show the efficacy of [aflibercept] with dosing every 2 months is clinically equivalent to monthly dosing of ran i bizu mab," she said. "This practical strategy with [aflibercept] involving reduced frequency of treatment and need for monitoring provides an opportunity for optimal vision benefit with less of a burden to patients,their families, and clinicians, and it also lowers cumulative risk for injection-related side effects."

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