Regeneron files wet AMD drug

Regeneron Pharmaceuticals has submitted a biologics licence application to the US Food and Drug Administration (FDA) for VEGF Trap-Eye for the treatment of wet age-related macular degeneration (AMD).

Regeneron said it has requested a priority review for the drug. Priority review status, which is reserved for drugs that have the potential to offer major advances in treatment, shortens the target review time to six months from the standard 10 months.

The company believes that VEGF Trap-Eye provides a significant treatment advance over existing therapies in that it can be injected into the eye every two months, rather than on a monthly basis. Regeneron's phase III studies showed that, after three initial loading doses, dosing with VEGF Trap-Eye every two months produced comparable efficacy to monthly injections of Roche's Lucentis (ranibizumab), which won US approval for wet AMD in 2006 after a six-month priority review.

Regeneron is conducting the global development programme for VEGF Trap-Eye in partnership with Bayer HealthCare, which has the rights to market the product outside of the US. The partnership deal, under which Regeneron has retained exclusive US rights, calls for the companies to share equally in any profits outside the US. Bayer HealthCare has said that it plans to submit European regulatory applications for the drug in the first half of this calendar year.

Wet AMD, in which new blood vessels grow beneath the retina and leak blood and fluid, is the leading cause of blindness for people over the age of 65 in the US and Europe, according to the companies.

In addition to wet AMD, Regeneron and Bayer are developing VEGF Trap-Eye as a potential treatment for central retinal vein occlusion, diabetic macular edema, myopic choroidal neovascularisation, and other eye diseases and disorders.