The European Commission has granted Healthcare products major Novartis International AG (NVS) a new indication for Lucentis to treat patients with visual impairment due to choroidal neovascularization or CNV secondary to pathologic myopia. The company said this makes Lucentis the first anti-VEGF therapy licensed for four indications in the European Union. Pathologic myopia often affects working-age adults and is a major cause of vision loss worldwide, with 1-3% of the general population.
CNV is the most common vision-threatening complication of high myopia. In patients with untreated myopic CNV the long-term prognosis is poor with around 90% of affected patients developing severe vision loss after 5 years.
RADIANCE, the Novartis-sponsored study in patients with myopic CNV, demonstrated that Lucentis provides rapid and superior improvement in visual acuity compared with the current licensed standard of care, Visudyne. The pivotal trial showed that there is an average 14-letter visual acuity gain in the first year with a median of 2 injections and over 60% of patients in RADIANCE did not need any further injections after 6 months.
According to Novartis, rapid visual acuity gains were achieved after only a single Lucentis injection and over 70% of patients treated with Lucentis in RADIANCE experienced a reduction in CNV leakage and intraretinal edema, with central retinal thickness being significantly reduced from as early as month one.
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