Novartis to file for new Lucentis (ranibizumab) indication in retinopathy of prematurity (ROP), a rare disease in premature infants that often leads to blindness - Seite 2

"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. 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," said Professor Andreas Stahl, Senior Physician in Retinal Surgery and Head of the Angiogenesis Research Group at the Eye Center, University of Freiburg, Germany.

Retinopathy of prematurity affects premature infants in both developed and developing countries, with an estimated 23,800 to 45,600 infants newly diagnosed with irreversible vision impairment from ROP each year[3]. Caused by the abnormal development of retinal blood vessels in premature infants, disease progression is due to high levels of a growth factor called VEGF[6]. After premature birth, high VEGF levels can cause an infant's blood vessels in the retina to develop abnormally, which may lead to structural abnormalities such as retinal detachment, resulting in vision loss or blindness[4],[6].

"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.

About Lucentis
Lucentis (ranibizumab injection), the first anti-vascular endothelial cell growth factor (anti-VEGF) therapy licensed for ophthalmic use, revolutionized the treatment of nAMD and has helped reduce blindness due to nAMD by 50% in several parts of the world. More than a decade of innovation and six indications (nAMD, DME, BRVO, CRVO, mCNV and other CNV) later, Lucentis continues to preserve and resolve vision for patients around the globe. We continue to investigate the possibility of Lucentis to transform the treatment of even the youngest, most vulnerable patients.