CHMP recommends Lucentis to treat preterm infants with retinopathy of prematurity

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (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.

The European Commission will review the CHMP opinion and is expected to deliver its final decision within three months. Lucentis, if approved for this indication, will be the first and only pharmacological therapy indicated for ROP in this vulnerable patient population. The submission is based on the randomized controlled clinical study, RAINBOW, which demonstrated that Lucentis is efficacious, safe, and well-tolerated for infants with ROP.

Laser surgery, the current standard of care, works by destroying the tissue in the eye that is responsible for the elevation of VEGF and can be associated with significant complications such as myopia and high myopia. While it is an effective treatment, there is a clear unmet need for innovative ways to treat ROP without destroying retinal tissue. Unlike laser surgery, Lucentis pharmacologically targets and reduces the elevated intraocular level of VEGF, the underlying cause of ROP. If approved in the EU, Lucentis (0.2 mg dose) will be indicated for the treatment of preterm infants with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease.