FDA approves Eylea (Regeneron) for Macular Oedema following Central Retinal Vein Occlusion - 25-Sep-2012

The FDA has approved Eylea (aflibercept) Injection, from Regeneron, for the treatment of Macular Oedema following Central Retinal Vein Occlusion (CRVO). The recommended dose for Eylea is 2 milligrams (mg) every 4 weeks (monthly). The approval of Eylea for Macular Oedema following CRVO was based on data from the Phase III COPERNICUS and GALILEO studies.

In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters of Best Corrected Visual Acuity (BCVA) at 24 weeks compared to baseline as measured by ETDRS. Results for the Eylea 2 mg monthly group were superior to those for the sham control group for the primary endpoint. Eylea is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in Eylea. Results from week 24 through 52 of the COPERNICUS and GALILEO studies have not yet been reviewed by the FDA.