Regeneron gains US FDA priority review for VEGF Trap-Eye in wet AMD

USA-based Regeneron Pharmaceuticals (Nasdaq: REGN) says that the US Food and Drug Administration has accepted for review the company's Biologics License Application (BLA) for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). The drug is being developed with German major Bayer (BAY: DE), which has rights to commercialize the product outside the USA.

The FDA also granted Regeneron’s request for priority review of its BLA. A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Under priority review, the target date for an FDA decision on the VEGF Trap-Eye BLA is August 20, 2011.

"We are very pleased that the FDA has chosen to grant priority review to VEGF Trap-Eye. We look forward to working closely with the FDA to achieve our goal of bringing a new treatment option that offers a major advance to patients with age-related macular degeneration," said Leonard Schleifer, president and chief executive of Regeneron.