RAINBOW study prompts filing of Lucentis for new indication in ROP

Novartis and Genentech have developed Lucentis (ranibizumab), the first anti-vascular endothelial cell growth factor therapy to secure a license for ophthalmic use. Whilst Genentech holds the rights to the product in the US, Novartis has rights in remaining parts of the world, and plans to file for a new indication in retinopathy of prematurity (ROP), a rare and potentially blinding disease in premature babies, caused by the abnormal development of retinal blood vessels.
225 premature infants with ROP underwent the RAINBOW phase III study which compared the efficacy and safety of two different concentrations of intravitreal Lucentis, which targets and reduces the elevated intraocular level of vascular endothelial growth factor, with laser surgery, the current standard of care, said to damage eye tissue and can be associated with significant complications such as high myopia.
Dirk Sauer, unit head at Novartis ophthalmology, 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.”