Novartis to file for new Lucentis® (ranibizumab) indication in retinopathy of prematurity (ROP), a rare disease in premature infants that often leads to blindness
(WorldNews Switzerland)

In the Phase III RAINBOW study, despite marginally missing statistical significance for the primary endpoint of demonstrating superiority of Lucentis® to laser surgery, Lucentis was shown to be an efficacious, safe and well-tolerated treatment for infants with ROP [1] Laser surgery, the current standard of care for ROP in infants, destroys diseased retinal tissue responsible for elevated vascular endothelial growth factor (VEGF) whereas Lucentis is an anti-VEGF that directly targets and reduces VEGF[2] With 80% of patients achieving treatment success with 0.2mg Lucentis versus 66% with laser, these data are clinically relevant[1] Novartis plans to file ex-US for a new indication in ROP to...