Novartis gets CHMP nod for Lucentis treatment for retinopathy of prematurity

Novartis International AG / Novartis receives positive CHMP opinion for Lucentis® treatment in preterm infants with retinopathy of prematurity (ROP), a disease causing visual impairment and blindness . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• Lucentis (ranibizumab), if approved in the EU for this indication, will be the first and only pharmacological therapy for ROP in these vulnerable infants
• 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 ROP[1]
• Standard of care treatment for ROP, laser surgery, destroys diseased retinal tissue responsible for elevated vascular endothelial growth factor (VEGF) whereas injectable Lucentis is a pharmacological therapy that directly targets and reduces VEGF[2]

https://www.marketscreener.com/NOVARTIS-9364983/news/Novartis-receives-positive-CHMP-opinion-for-Lucentis-treatment-in-preterm-infants-with-retinopath-28963737/