The Australian Therapeutic Goods Administration (TGA) has approved Bayer HealthCare's Eylea (aflibercept) injection for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD).
FDA-approved Eylea injection is a recombinant fusion protein, consisting of portions of human Vascular Endothelial Growth Factor (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.
The approval is backed by the results from the two positive Phase 3 clinical studies, VIEW 1 and VIEW 2, which demonstrated that Eylea dosed every other month, following three initial monthly injections, was non-inferior to Lucentis dosed every four weeks, as measured by the primary endpoint of maintenance of visual acuity (less than 15 letters of vision loss on an eye chart) over 52 weeks.
Eylea is currently in a Phase 3 clinical study for the treatment of wet AMD in China, diabetic macular edema (DME), myopic choroidal neovascularisation (mCNV), and branch retinal vein occlusion (BRVO).
The drug has been cleared for use at a recommended dose of 2mg via intravitreal injection per month for three consecutive months, followed by 2mg via intravitreal injection every two months.
Eylea-related common adverse reactions included conjunctival hemorrhage, cataract, eye pain, vitreous detachment, vitreous floaters, and increased intraocular pressure.
Bayer HealthCare has submitted applications for marketing authorisation in Europe, Japan, and other countries for Eylea for the treatment of wet AMD in 2011, and Regeneron has filed an sBLA for Eylea in central retinal vein occlusion (CRVO) in the US.
The company is likely to introduce Eylea in Australia in the second half of this year.