Novartis announced the European approval of Lucentis (ranibizumab) for preterm infants with retinopathy of prematurity (ROP), making it the first and only licensed pharmacological treatment for this indication.
The approval is based on the landmark RAINBOW study, showing Lucentis is an efficacious and safe treatment for infants with ROP.
The standard of care treatment for ROP, laser surgery, destroys diseased retinal tissue responsible for elevated vascular endothelial growth factor (VEGF), whereas pharmacological therapy, Lucentis, directly targets and reduces VEGF .
Lucentis (0.2 mg) 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 EU .
“Everyone deserves the best start in life, so Novartis has reimagined what is possible in the treatment of ROP for this particularly vulnerable patient group,” Dirk Sauer, Development Unit Head, Novartis Ophthalmology, said in a Novartis statement. “The European Commission decision to approve Lucentis in this indication gives clinicians the first and only licensed alternative to laser therapy in the treatment of preterm infants with ROP in the EU. We look forward to providing pediatric retinal specialists with a new therapeutic option for preterm infants with ROP.”
- Clinicaltrials.gov. (2018). RAINBOW Study: Ranibizumab Compared With Laser Therapy for the Treatment of Infants Born Prematurely With Retinopathy of Prematurity – Study Results – ClinicalTrials.gov. [online] Available at: https://clinicaltrials.gov/ct2/show/results/NCT02375971 [last accessed 04/09/19]
- Mintz-Hittner, H., Kennedy, K. and Chuang, A. (2011). Efficacy of Intravitreal Bevacizumab for Stage 3+ Retinopathy of Prematurity. New England Journal of Medicine, 364(7), pp.603-615
- Novartis Europharm Limited. Lucentis (ranibizumab): Summary of Product Characteristics. Available from: DATA ON FILE