Positive Long-Term Results Reported for Aflibercept (Eylea) in Patients With Diabetic Macular Edema
Phase III trial shows improved visual acuity versus laser photocoagulation (February 10)
In a long-term phase III trial, aflibercept (Eylea, Regeneron Pharmaceuticals/Bayer Health Care) has shown sustained improvement from baseline in best corrected visual acuity (BCVA) at week 100 compared with laser photocoagulation in patients with diabetic macular edema (DME).
Patients in the VISTA-DME study were randomly assigned to receive aflibercept 2 mg dosed monthly (2Q4; n = 155); aflibercept 2 mg dosed every 2 months (after 5 initial monthly injections) (2Q8; n = 152); or the comparator treatment of laser photocoagulation (n = 154).
After 2 years of treatment, patients receiving aflibercept 2Q4 had a mean change from baseline in BCVA of 11.5 letters (12.5 letters at 52 weeks), and patients receiving aflibercept 2Q8 had a mean change from baseline in BCVA of 11.1 letters (10.7 letters at 52 weeks). In contrast, patients in the laser photocoagulation group had a mean change from baseline in BCVA of 0.9 letters (0.2 letters at 52 weeks).
Eylea (aflibercept) was approved in the U.S. for the treatment of neovascular (wet) age-related macular degeneration (AMD) in November 2011 and for macular edema following central retinal vein occlusion (CRVO) in September 2012.
In patients with DME, hyperglycemia-induced vascular dysfunction and hypoxia result in elevated intraocular levels of vascular endothelial growth factor (VEGF) and resultant blood-vessel permeability leading to macular edema, which can result in vision loss.
Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human immunoglobulin G1 and formulated as an iso-osmotic solution for intravitreal administration. Aflibercept acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF), thereby inhibiting the binding and activation of their cognate VEGF receptors.
Source: Regeneron; February 10, 2014.