New EU indication for Novartis's Lucentis
This article was originally published in Scrip
Novartis's Lucentis (ranibizumab) has now received EU approval for a fourth indication: choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV).
The anti-VEGF product is the first licensed therapy to improve vision in patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia. It was first approved in wet AMD and is also already approved for the treatment of visual impairment due to diabetic macular edema and for visual impairment due to macular edema secondary to retinal vein occlusion (RVO), including both branch- and central-RVO. Lucentis was developed with Genentech, which has US commerical rights to the product.
The latest approval was based on the results of the RADIANCE trial which showed that Lucentis provided rapid and superior improvement in visual acuity compared with the current licensed standard of care, Novartis's older photodynamic therapy Visudyne (verteporfin PDT). There was an average 14-letter visual acuity gain in the first year with a median of two injections and over 60% of patients in RADIANCE did not need any further injections after six months.
Novartis hopes that 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 the condition. However, it is likely to have to compete at some point with Bayer/Regeneron's Eylea (aflibercept), which is due to have its first filing in this indication in Asia (where this condition is most common) by the end of the year, based on the promising MYRROR trial data (scripintelligence.com, 6 June 2013).