Regeneron has announced that detailed one-year results from the VIEW 1 and VIEW 2 phase 3 studies of Aflibercept ( Eylea ) injection, published in the journal Ophthalmology.
Eylea, for the treatment of patients with neovascular ( wet ) age-related macular degeneration ( wet AMD ) has been approved by the Food and Drug Administration ( FDA ) and by the European Commission.
The approval has been based upon the results of two phase 3 clinical studies, VIEW 1 and VIEW 2. In these studies, EYLEA dosed every eight weeks, following three initial monthly injections, was shown to be clinically equivalent to Ranibizumab ( Lucentis ) dosed every four weeks, as measured by the primary endpoint of maintenance of best-corrected visual acuity ( less than 15 letters of vision loss on an eye chart as measured on an ETDRS scale ) over 52 weeks.
The safety and efficacy of Aflibercept were assessed in two randomized, multi-center, double-masked, active-controlled studies in patients with wet AMD. A total of 2412 patients were treated and evaluable for efficacy ( 1817 with Aflibercept ) in the two studies ( VIEW 1 and VIEW 2 ). In each study, patients were randomly assigned in a 1:1:1:1 ratio to one of four dosing regimens: 1) Aflibercept administered 2 mg every eight weeks following three initial monthly doses ( Aflibercept 2Q8 ); 2) Aflibercept administered 2 mg every four weeks ( Aflibercept 2Q4 ); 3) Aflibercept 0.5 mg administered every four weeks ( Aflibercept 0.5Q4 ); and 4) Ranibizumab administered 0.5 mg every four weeks ( Ranibizumab 0.5Q4 ).
Patient ages ranged from 49 to 99 years with a mean of 76 years.
In both studies, the primary efficacy endpoint was the proportion of patients who maintained vision, defined as losing fewer than 15 letters of best-corrected visual acuity at week 52 compared to baseline. Both the Aflibercept injection 2Q8 and 2Q4 dosing groups were shown to have efficacy that was clinically equivalent to the Ranibizumab 0.5Q4 group for the primary endpoint.
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 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.
In the United States, Eylea was also approved for the treatment of macular edema following central retinal vein occlusion ( CRVO ) in September 2012. Phase 3 trials are currently underway with EYLEA for the treatment of diabetic macular edema ( DME ) and macular edema following branch retinal vein occlusion ( BRVO ).
Eylea is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients.
The most common adverse reactions ( frequency of 5% or more ) reported in wet AMD patients receiving Eylea were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure. ( Xagena )
Source: Regeneron, 2012