Eylea Injection Recommended for Approval for the Treatment of Visual Impairment Due to Macular Edema Secondary to CRVO/BRVO
Regeneron Pharmaceuticals has announced that Eylea (aflibercept) Injection has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to macular edema secondary to central or branch retinal vein occlusion (CRVO/BRVO).
The European Union (EU) submission is based on the previously-approved indication for macular edema secondary to CRVO and the positive data from the Phase III VIBRANT study.
Eylea is approved in the US for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), which includes both CRVO and BRVO, and Diabetic Macular Edema (DME). EYLEA has also been approved in the EU and other markets for use in wet AMD and DME.
Bayer HealthCare and Regeneron are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to Eylea in the US. Bayer HealthCare licensed the exclusive marketing rights outside the US, where the companies share equally the profits from sales of Eylea, with the exception of Japan where Regeneron receives a percentage of net sales.
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