Great news for Regeneron Pharmaceuticals came in the shape of unanimous backing from a panel of US regulatory advisors for its eye drug Eylea, taking the drug a giant step closer to market approval.
Eylea (aflibercept), which is also known as VEGF Trap-Eye, has been backed by the US Food and Drug Administration's Ophthalmic Drugs Advisory Committee as a treatment of the neovascular form of age-related macular degeneration, a leading cause of blindness.
The submission was based on positive results from two Phase III trials, known as VIEW 1 study and VIEW 2, which showed that all regimens of Eylea met the primary endpoint of showing non-inferiority compared to the current standard of care, Genentech's Lucentis (ranibizumab).
If approved, it is widely believed that Eylea could become a hot contender for market share, particularly as the drug can be given every two months (following loading doses) while Lucentis is administered monthly, making it more convenient for patients.
"The positive recommendation by the advisory committee is an important step toward providing wet AMD patients with a new treatment option that could potentially reduce the burden that exists with current therapies," commented George Yancopoulos, president of Regeneron Research Laboratories.
Regeneron's partner Bayer HealthCare submitted an application to market the drug in Europe this month, and the companies are also developing Eylea for the treatment of central retinal vein occlusion, diabetic macular edema, and other eye diseases and disorders.