Novartis To File For New Lucentis Indication In ROP

(RTTNews) - Novartis (NVS) announced results from Phase III study of Lucentis (ranibizumab) versus laser surgery at the 18th Congress of the European Society of Retina Specialists (EURETINA) in premature infants with retinopathy of prematurity.

Novartis announced that it plans to file ex-US for a new indication in ROP to bring transformative treatment to premature infants facing severe vision loss -the first anti-VEGF product to seek an ROP indication

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.

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

With 80% of patients achieving treatment success with 0.2mg Lucentis versus 66% with laser, the data are clinically relevant, the company noted.