Bayer submits Eylea for use in BRVO

Bayer has submitted Eylea for European approval for use in macular oedema following branch retinal vein occlusion (BRVO).

The injectable biologic is competing with Novartis’ rival Lucentis in the therapy area, where Lucentis is already approved for retinal vein occlusion (RVO).

The drug is co-marketed by Bayer and Regeneron, with Regeneron retaining the US revenues and licensing out marketing to Bayer in the rest of the world.

Earlier this year Regeneron said it expects Eylea to reach global sales of $1.7-$1.8 billion this year, thanks to expanding use and indications.

Eylea was first approved in 2011 for age-related macular degeneration (AMD) and for macular oedema following Central Retinal Vein Occlusion (CRVO) in 2012, and has been building sales rapidly.

RVO is the second most common retinal vascular disorder and is a significant cause of visual impairment, with BRVO being the most common. In BRVO, a blockage occurs in the blood vessels branching from the main vein draining the retina, resulting in the release of vascular endothelial growth factor and consequent retinal oedema.

Bayer’s submission is based on the positive Phase 3 VIBRANT trial, a double-masked, randomised, active-controlled study of patients with macular oedema following BRVO. In the VIBRANT study, 53 percent of patients who received EYLEA 2 milligram (mg) monthly gained at least 15 letters (equivalent to three lines) in best-corrected visual acuity (BCVA) from baseline at week 24, the primary endpoint of the study, compared to 27 percent of patients who received laser, a standard of care treatment.

In addition, EYLEA met a key secondary endpoint, achieving a 17.0 letter mean improvement over baseline in BCVA compared to a 6.9 letter mean improvement in patients who received laser.

Regulatory submissions have also been made in the US for Eylea for macula oedema following BRVO, and in the US and EU for the treatment of Diabetic Macular Edema (DME).

Eylea is usually given every 4 weeks (monthly) for the first three months, and then once every eight weeks after that.

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