The FDAâ€™s decision follows the EUâ€™s decision last month to similarly expand the scope of the drugâ€™s approval to include more specific causes of vision loss and blindness.
Ranibizumab (Lucentis/Genentech) has been approved by the US Food and Drug Administration (FDA) for the treatment of myopic choroidal neovascularization (mCNV), the drugâ€™s maker announced today. The decision makes it the first anti-vascular endothelial growth factor (VEGF) to be approved for the treatment of the condition in the United States.
Ranibizumab, an injection previously approved for the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), performed well enough in clinical trials for mCNV to earn the FDAâ€™s blessing. In the phase 3 RADIANCE trial, patients receiving ranibizumab regained 12 letters of visual acuity at three months, compared to less than two letters in a group receiving verteporfin photodynamic therapy. The study included 276 patients and two ranibizumab groups, both of which showed 12 or more letters of progress.
Choroidal neovascular membranes (CNVM) are new blood vessels that grow in the choroid and leak into the retina, which can lead to blindness and myopia. CNVM are commonly associated with wAMD and are typically painless, but can cause serious and irreversible vision loss.
Genentechâ€™s press release cites a 2016 study published in Opthalmology claiming that mCNV impacts as many as 0.017% of adults in the United States, or about 41,000 people. The conditionâ€™s rarity lies in the fact that it really is two conditions: myopia, or nearsightedness cause by the eye being longer than it is tall, and CNVM.
Ranibizumab, and other anti-VEGF drugs, are thought to work by inhibiting a key protein responsible for the growth and permeability of new blood vessels. Side effects in the RADIANCE trial were reportedly consistent with those found in previous studies of the drug. The FDAâ€™s decision follows the EUâ€™s decision last month to similarly expand the scope of the drugâ€™s approvals to include more specific causes of vision loss and blindness.