The European Commission has granted Novartis a fourth approval for its eye drug Lucentis, this time to treat patients with visual impairment due to choroidal neovascularisation secondary to pathologic myopia.
The approval is based on the Radiance trial in patients with myopic CNV which showed that Lucentis (ranibizumab) provides rapid and superior improvement in visual acuity compared with the current standard of care, Novartis' own Visudyne (verteporfin). Specifically, there is an average 14-letter visual acuity gain in the first year with a median of two injections and over 60% of patients did not need any further injections after six months.
Pathologic myopia is a major cause of vision loss worldwide, affecting 1%-3% of the general population, and CNV is the most common vision-threatening complication of high myopia. In patients with untreated myopic CNV, 90% develop severe vision loss after five years.
Tim Wright, head of development at Novartis Pharmaceuticals, said that this fourth indication for Lucentis "shows how far we have come since it was first launched in 2006,". He added that it is "the first and only licensed treatment that has been proven to restore vision in patients with visual impairment due to myopic CNV".
Lucentis is licensed for the treatment of wet age-related macular oedema. diabetic macular oedemav and for visual impairment caused by macular oedema secondary to central or branch retinal vein occlusion. Roche's Genentech sells the drug in the USA.