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Saturday, September 22, 2018

Novartis: to file for new Lucentis indication in retinopathy of prematurity


* In the Phase III RAINBOW study, despite marginally missing statistical
significance for the primary endpoint of demonstrating superiority of
Lucentis(®) to laser surgery, Lucentis  was shown to be an efficacious, safe
and well-tolerated treatment for infants with ROP [1]
* Laser surgery, the current standard of care for ROP in infants, destroys
diseased retinal tissue responsible for elevated vascular endothelial growth
factor (VEGF) whereas Lucentis is an anti-VEGF that directly targets and
reduces VEGF[2]
* With 80% of patients achieving treatment success with 0.2mg Lucentis versus
66% with laser, these data are clinically relevant[1]
* Novartis plans to file ex-US for a new indication in ROP to bring
transformative treatment to premature infants facing severe vision loss –
the first anti-VEGF product to seek an ROP indication

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