Bayer, Regeneron’s Eylea gets additional EU indication
The European Commission has granted a fifth indication to Bayer and Regeneron’s eye drug Eylea (aflibercept injection), which is now also approved for the treatment of visual impairment due to myopic choroidal neovascularisation (myopic CNV), a retinal disease associated with high degrees of near-sightedness.
Myopic CNV frequently affects people of working age who are severely myopic and have pathological changes in the back of the eye. The disease is characterised by abnormal elongation of the eye with a physical stretching of the sclera, choroid and retina, resulting in degenerative and progressive changes.
Eylea is already approved in the EU for the treatment of patients with neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, and visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO).
Bayer and Regeneron are collaborating on the global development of Eylea, with Regeneron maintaining exclusive US rights to the drug and Bayer outside of the United States, where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales. Eylea is already approved for myopic CNV in Japan.
Bayer said it is planning immediate introduction of Eylea to the market for this new indication, with Germany being one of the first launch countries in Europe.
The drug has already been a sales success for the company, which last week announced Eylea revenues rose 67% for Q3.
"The results of the Phase III study were very encouraging, with the majority of patients experiencing a significant two-line improvement in visual acuity on a standard eye chart with aflibercept solution for injection”, says Dr Joerg Moeller, a member of the Bayer HealthCare Executive Committee and head of global development. “A treatment option that could not only prevent permanent vision loss, but also improve visual acuity could have great benefits for patients with myopic CNV.”
Published on 02/11/15