Novartis’ Lucentis gets EU approval to treat pathologic myopia

7th July 2013 (Last Updated July 7th, 2013 18:30)

The European Commission has approved Novartis’ Lucentis (ranibizumab) for the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (myopic CNV).

The European Commission has approved Novartis' Lucentis (ranibizumab) for the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (myopic CNV).

First launched in 2006 and developed by Genentech and Novartis, the ophthalmology drug Lucentis is a humanised therapeutic antibody fragment that restricts biologically-active forms of vascular endothelial cell growth factor-A (VEGF-A).

The latest approval is the fourth for the drug in the EU, where it is already licensed to treat wet age-related macular degeneration (AMD), visual impairment due to diabetic macular edema and for visual impairment due to macular edema secondary to retinal vein occlusion.

Novartis Pharmaceuticals global development head Tim Wright said: "We expect that the use of Lucentis will significantly change the treatment of myopic CNV, as it is the first and only licensed treatment that has been proven to restore vision in patients with visual impairment due to myopic CNV."

In the Novartis-sponsored twelve-month Radiance clinical trial in patients with myopic CNV, ranibizumab 0.5 mg demonstrated efficacy and safety by providing rapid and superior improvement in visual acuity against verteporfin photodynamic therapy.

Novartis said that with a median of two injections of Lucentis, a 14-letter visual acuity gain was observed in the first year on average. More than 60% of patients in the Radiance study did not require injections after six months, and about 70% experienced a decrease in CNV leakage and intraretinal edema.

Lucentis is marketed by Genentech in the US and Novartis in the rest of the world.

Pathologic myopia or myopic CNV is a common eye complaint among working-age adults, which can leave patients with severe vision loss after five years.