BRIEF—New EU approval for Novartis' Lucentis

Swiss pharma giant Novartis has gained European Commission approval for Lucentis (ranibizumab) in preterm infants with retinopathy of prematurity (ROP), which has come through much sooner than the company expected.

The approval is based on the landmark RAINBOW study, showing Lucentis is an efficacious and safe treatment for infants with ROP, a rare eye disease but a leading cause of childhood blindness.

Lucentis (0.2mg dose) is indicated in preterm infants for the treatment of ROP with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease, making it the only approved pharmacological therapy for this indication in the European Union.