Regeneron Pharmaceuticals Inc. (REGN) announced Friday that the U.S. Food and Drug Administration or FDA has approved Eylea (aflibercept) Injection for the treatment of Macular Edema following Central Retinal Vein Occlusion or CRVO. The recommended dose for EYLEA is 2 milligrams (mg) every 4 weeks or monthly.
The company said that the approval of Eylea for Macular Edema following CRVO was based on data from the Phase 3 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.
The company stated that results from week 24 through 52 of the Copernicus and galileo studies have not yet been reviewed by the FDA.
In the United States, Eylea (aflibercept) Injection is indicated for the treatment of patients with neovascular (Wet) Age-related Macular Degeneration (AMD). The recommended dose for Eylea is 2 mg administered by intravitreal injection every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months).
Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated when Eylea was dosed every 4 weeks compared to every 8 weeks, the company said.
The most common adverse reactions (5% or more) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.
Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with Eylea including endophthalmitis, traumatic cataract, increased intraocular pressure, and vitreous detachment.
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