Biologics license applied for wet AMD treatment

Mar 11, 2011

A Biologics License Application (BLA) for VEGF Trap-Eye treatment of neovascular age-related AMD has been submitted to the US Food and Drug Administration (FDA) by Regeneron Pharmaceuticals.

A Biologics License Application (BLA) for VEGF Trap-Eye treatment of neovascular age-related AMD has been submitted to the US Food and Drug Administration (FDA) by Regeneron Pharmaceuticals.

The request also includes a Priority Review to shorten the length of time between the submission of the BLA to FDA implementation. This would cut the time under the prescription drug user fee act (PDUFA) from ten months to six months.

Dr Leonard S. Schleifer, President and CEO of Regeneron, said: "There have been significant advances in the treatment of wet AMD in recent years. However, the need for monthly intravitreal injections to obtain optimal vision gains has resulted in a significant burden for physicians, patients and their carers."

The VEGF Trap-Eye BLA is based on successful results from two randomized, double-masked Phase III trials, VIEW 1 in the US and VIEW 2 worldwide. Every 2 months, 2 mg of VEGF Trap-Eye treatment was administered after three loading doses and the results were compared to those obtained with the present treatment of monthly 0.5 mg ranibizumab doses.

Dr Schleifer added: "Patients treated with VEGF Trap-Eye 2 mg every 2 months, following three loading doses, could be dosed with fewer injections over one year without compromising efficacy."

x