Bayer’s Eylea 8 mg has officially been approved for third retinal indication in the EU

Bayer announces that the European Commission has granted marketing authorization in the EU for Eylea 8 mg for the treatment of patients with visual impairment due to macular edema following retinal vein occlusion including branch, central and hemiretinal vein occlusion. RVO is the third indication for Eylea 8 mg.

“Retinal vein occlusion often presents with sudden vision loss and affects older people who are still of working age. Early diagnosis and treatment are essential to help prevent irreversible vision loss; however, the treatment burden of frequent injections can be challenging for patients. In the Phase III clinical trial QUASAR, Eylea 8 mg demonstrated in the key secondary endpoint that it can meaningfully reduce the number of injections while maintaining visual acuity and providing a favorable safety profile,” said Richard Gale, Professor of Ophthalmology Hull York Medical School, University of York, and Consultant Medical Ophthalmologist, and one of the trial investigators.

“Eylea 8 mg represents a new treatment option for patients with macular edema due to retinal vein occlusion, addressing the demand for more durable therapies. The recent approval in the European Union expands the range of retinal indications for Eylea 8 mg – now encompassing wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.

Note that the study has met its primary endpoint at week 36, demonstrating that patients receiving Eylea 8 mg every 2 months achieved non-inferior visual acuity gains and robust fluid control compared to those receiving Eylea 2 mg monthly. Additional submitted data show that visual acuity was maintained with Eylea 8 mg, and unparalleled durability was demonstrated through the end of the study at week 64.

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Bayer, Eylea, third retinal indication