26 July 2019 - Positive opinion is based on the landmark Phase III RAINBOW trial, which showed that Lucentis (ranibizumab) is an efficacious, safe and well-tolerated treatment for infants with retinopathy of prematurity.

Novartis today announced that the CHMP of the EMA has recommended approval of Lucentis (ranibizumab 10 mg/ml) for the treatment of preterm infants with retinopathy of prematurity (ROP). ROP is a rare eye disease but a leading cause of childhood blindness.

Lucentis, if approved for this indication, will be the first and only pharmacological therapy indicated for ROP in this vulnerable patient population.

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