Novartis to File for New Lucentis (Ranibizumab) Indication in Retinopathy of Prematurity (ROP)
Novartis announced results from a phase 3 study of Lucentis (ranibizumab) versus laser surgery (the current standard of care) in premature infants with retinopathy of prematurity (ROP). Unlike laser surgery, which damages eye tissue and can be associated with significant complications such as high myopia, Lucentis pharmacologically targets and reduces the elevated intraocular level of vascular endothelial growth factor (VEGF), which is the underlying cause of the condition, according to Novartis.
Although the RAINBOW phase 3 study marginally missed statistical significance for the primary endpoint (P=0.0254, as opposed to the significance level of P=0.025), the difference in treatment success between the Lucentis 0.2mg and 0.1mg groups compared to laser surgery (80%, 75% and 66.2% respectively) is nevertheless considered clinically relevant by Novartis. Based on the favorable benefit-risk profile, Novartis plans to file for a new indication for Lucentis for the treatment of ROP to support this rare but important patient population.
“Laser surgery, the current standard of care, works by destroying the tissue in the eye that contributes to the elevation of VEGF. While it is an effective treatment, there is a clear unmet need for innovative ways to treat ROP without destroying retinal tissue,” Professor Andreas Stahl, Senior Physician in Retinal Surgery and Head of the Angiogenesis Research Group at the Eye Center, University of Freiburg, Germany, said in a company news release. “Lucentis demonstrated in the RAINBOW study that it is an efficacious and well tolerated option for the treatment of ROP that may offer new hope to parents of this vulnerable patient population.”
“The RAINBOW study is part of our ongoing commitment to addressing the most urgent needs in eye care. We look forward to filing outside the US for an indication in ROP, which may bring us one step closer to reimagining care for these premature infants,” said Dirk Sauer, Development Unit Head, Novartis Ophthalmology.