Novartis has unveiled plans to file ex-US for a new indication for Lucentis (ranibizumab) in retinopathy of prematurity (ROP), a rare disease in premature infants.
ROP is a rare and potentially blinding resulted due to abnormal development of retinal blood vessels in premature babies.
The company has presented data from a Rainbow phase III study of Lucentis versus laser surgery in premature infants with ROP.
According to the company, the 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.
Rainbow is a randomized, open-label, controlled and multicenter study that compared the efficacy and safety of intravitreal Lucentis with laser surgery in 225 patients with ROP.
The trial compared two different concentrations of Lucentis, 0.1mg and 0.2mg, to the current standard of care, laser surgery.
The outcomes of the study have been measured at 24 weeks after beginning the trial, while long-term extension trial is currently underway and expected to be completed by the end of fourth quarter of 2022.
Lucentis pharmacologically is said to target and reduce the elevated intraocular level of vascular endothelial growth factor (VEGF), while laser surgery is expected to damage eye tissue and can be associated with significant complications such as high myopia.
Novartis ophthalmology unit head Dirk Sauer said: “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.”
Lucentis is the first anti-vascular endothelial cell growth factor (anti-VEGF) therapy, which secured license for ophthalmic use.
Lucentis is marketed in over 110 countries, as well as supported by a portfolio of 251 sponsored clinical studies.
Novartis, along with Genentech, has developed Lucentis. Genentech holds the rights to Lucentis in the US, while Novartis has rights in remaining parts of the world.