

Bayer reported Tuesday the filing of a marketing application seeking
European approval of the experimental agent VEGF Trap-Eye (aflibercept) for the treatment of wet age-related macular degeneration (AMD).
The company, along with partner Regeneron Pharmaceuticals, said the submission was based on data from two Phase III trials, results of which were announced in November last year.
Both the VIEW 1 and VIEW 2 studies showed that in patients with wet AMD all regimens of VEGF Trap-Eye, including a once every two month dose, met the primary endpoint of non-inferiority compared to standard therapy of Roche's Lucentis (ranibizumab) dosed once monthly.
Regeneron submitted a regulatory application for the drug in the US in February and received priority review, with a decision from the FDA expected by August 20.
Bayer, which will market VEGF Trap-Eye outside the US, has indicated it expects peak annual sales of between 250 million euros ($367 million) and 500 million euros ($734 million) for the product.