Novartis’ eye drug Lucentis gains fourth indication approval in Europe

July 5 2013 | By Márcio Barra

In a press release launched today, Novartis announced that the EU has approved Lucentis (Ranibizumab) as the  first effective treatment of sight problems caused by choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV).

CNV is the most common vision-threatening complication of high myopia, with approximately 90% of affected patients younger than 50 years old eventually developing severe vision loss after five years.

Data for the approval came from the Novartis sponsored RADIANCE trial, where lucentis showed an average 14-letter visual acuity gain in the first year with a median of two injections, compared with the current standard of care, Visudyne® (verteporfin PDT), from Valeant Ophthalmics,  and over 60% of patients did not need any further injections after six months,

“This fourth indication for our pioneering ophthalmology drug, Lucentis, shows how far we have come since it was first launched in 2006,” Tim Wright, Novartis’ global head of development, following the approval. Furthermore, Lucentis is “the first and only licensed treatment that has been proven to restore vision in patients with visual impairment due to myopic CNV”.

In Europe, Lucentis is already approved for the treatment of wet age-related macular oedema, diabetic macular oedema and for visual impairment caused by macular oedema secondary to central or branch retinal vein occlusion.

Lucentis biggest completion is Eylea (aflibercept), from Bayer, which received approval from the UK’s NICE in March this year for wet age-related macular degeneration (AMD), like lucentis did back in 2008. Eylea has a lower frequency of treatment that Lucentis –  given monthly for three consecutive doses, followed by one injection every two months in the case of Eylea versus one injection per month for three consecutive months, followed by a phase in which patients are monitored for visual acuity every month at a hospital, where a further dose can be administered if needed for Lucentis.

Lucentis is an antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor-A (VEGF-A).Binding of VEGF-A to its receptors leads to endothelial cell proliferation and neovascularisation, as well as vascular leakage, leading to wet AMD and other ocular diseases such as diabetic macular edema (DME) and retinal vein occlusion (RVO).

Read the press release

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