Company will submit a marketing approval application to the FDA by the end of 2018.
Age-related macular degeneration (AMD) is one of the leading causes of the loss of eyesight among older Americans, with more than 2 million suffering from the disease in the country (and 20–25 million globally), according to the National Eye Institute.
Two of the key drugs on the market for AMD are Eylea (aflibercept) from Regeneron and Lucentis (ranibizumab) from Genentech/Novartis. Both are biologics that are injected into the eye.
Novartis is developing a newer drug that it hopes will outperform Eylea in the market. Also a biologic, brolucizumab has the benefit of being injected into the just once every three months compared with once every two months (eight weeks) for Eylea.
Early clinical results suggested that brolucizumab gives results that are “no worse than” Eylea with respect to the treatment of AMD. These results have recently been confirmed () in two two-year late-stage trials. These trials also confirmed that retinal thickness and retinal fluid were reduced more effectively with brolucizumab than Eylea.
With these additional positive results in hand, Novartis is expected to submit a market application to the U.S. Food and Drug Administration for brolucizumab in AMD. The company could potentially receive approval in 2019.
