Roche group Genentech's application to use Lucentis for the treatment of myopic choroidal neovascularization (mCNV) has been approved by the US Food and Drug Administration, giving patients the chance to access the first anti-vascular endothelial growth factor (VEGF) therapy for the condition.
mCNV is a complication of severe near-sightedness that can lead to blindness, believed to affect around 41,000 people in the US.
In those with the condition, new, abnormal blood vessels grow directly into the retina which can break and leak blood or fluid into the retina, possibly causing irreversible central vision loss.
Lucentis (ranibizumab injection) is designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.
In the Phase III RADIANCE study, treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy (vPDT); at three months, average visual acuity gains were more than 12 letters versus 1.4 letters, respectively.
Also, treatment with both Lucentis and vPDT was generally well-tolerated, with very low incidences of ocular and non-ocular serious adverse events reported.
The approval marks the fifth for Lucentis, which is already on the US market for wet age-related macular degeneration, macular oedema after retinal vein occlusion, diabetic macular oedema (DME), and diabetic retinopathy in people with DME.