Bayer HealthCare has announced that Eylea ( Aflibercept solution for injection ) has been approved by the European Commission ( EC ) for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion ( CRVO ).
The approval of Eylea was based on results from two phase 3 randomized, multicenter, double-masked, sham-controlled studies: COPERNICUS ( Controlled Phase 3 Evaluation of Repeated Intravitreal Administration of VEGF Trap-Eye In Central Retinal Vein Occlusion: Utility and Safety ) trial ( 187 patients ) and GALILEO ( General Assessment Limiting Infiltration of Exudates in Central Retinal Vein Occlusion with VEGF Trap-Eye ) trial ( 171 patients ).
Patients were randomly assigned in a 3:2 ratio to receive intravitreal injections of Aflibercept 2 mg or sham injections every 4 weeks for 6 months.
At 6 months, patients in the sham group were allowed to cross over to receive Aflibercept as needed, and those in the Aflibercept group continued to receive it as needed for the next 6 months.
The primary endpoint for both trials was the proportion of patients with improved best corrected visual acuity of at least 15 letters from baseline to 24 weeks on the Early Treatment Diabetic Retinopathy Study chart.
In the COPERNICUS trial, the primary endpoint was met by 56.1% of the patients in the Aflibercept group and 12.3% in the sham control group ( P less than 0.001 ).
At week 52, 55.3% of patients in the Aflibercept group gained 5 or more letters compared with 30.1% of those in the sham group ( P less than 0.001 ).
In the GALILEO trial, the primary endpoint was met by 60.2% in the Aflibercept group and 22.1% in the sham group ( P less than 0.001 ).
In the COPERNICUS trial at week 52, patients in the treatment group gained a mean of 16.2 letters compared with 3.8 letters for those in the sham group.
In the GALILEO trial, patients in the treatment group gained a mean of 18.0 letters compared with 3.3 letters in the sham group ( P less than 0.0001 ).
In both trials, the most common adverse events were eye pain ( 13% Aflibercept, 5% sham ), conjunctival hemorrhage ( 12% Aflibercept, 11% sham ), and increased intraocular pressure ( 8% Aflibercept, 6% sham ).
Eylea is already approved in European Union in patients suffering from wet age-related macular degeneration.
Over 66,000 people in major European countries and more than 100,000 people in the United States are estimated to suffer from CRVO.
Central retinal vein occlusion is caused by obstruction of the central retinal vein that leads to an accumulation of deoxygenated blood and fluid in the retina.
Macular edema secondary to CRVO causes retinal damage and loss of vision.
Release of vascular endothelial growth factor ( VEGF ) contributes to increased vascular permeability in the eye and macular edema. It has been shown that anti-VEGF treatment may help decrease vascular permeability and edema in the retina in patients with CRVO.
Eylea is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 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 ) and thereby can inhibit the binding and activation of these cognate VEGF receptors. ( Xagena )
Source: Bayer HealthCare, 2013