Regeneron Pharmaceuticals has received good news from regulators on both sides of the Atlantic concerning its eye drug Eylea.
First up, the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion on Eylea (aflibercept) as a treatment for wet age-related macular degeneration. The drug is partnered with Bayer outside the USA and the European Commission is expected to grant approval in the fourth quarter.
The US Food and Drug Administration approved Eylea in November 2011 for wet AMD, the leading cause of blindness for people over the age of 65, and it is selling very well. Regeneron expects US sales to be in the region of $700-$750 million.
Approval in USA for new indication
That figure could be boosted by the news that the FDA has now approved Eylea for another indication, the treatment of macular oedema following central retinal vein occlusion (CRVO).
Regeneron chief scientific officer George Yancopoulos noted that in Phase III studies, Eylea has been shown to significantly improve visual outcomes in a disease characterised by high VEGF levels. Bayer plans to submit the drug in this indication in Europe shortly and Phase III trials are currently underway with Eylea for diabetic macular oedema and macular oedema following branch retinal vein occlusion (BRVO).