Novartis has received an approval from the European Commission for its Lucentis (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV).
Lucentis is a humanized therapeutic antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor-A (VEGF-A).
The first anti-VEGF therapy, Lucentis is intended to save the eye sight and is given license for four indications in the EU.
The treatment of myopic CNV starts with a single injection, and further injections are based on an individualized regimen, according to the European label.
The retreatment depends on the vision and anatomical changes, and the patients are to be monitored every month for about initial two months and then at least quarterly check up has to be performed up to one year.
A clinical trial in patients with myopic CNV, Radiance demonstrated that Lucentis offered rapid and better improvement in visual acuity compared to the current licensed standard of care, Visudyne (verteporfin PDT).
Novartis Pharmaceuticals Development global head Tim Wright said this fourth indication for the company's ophthalmology drug, Lucentis, shows how far it has come since it was first launched in 2006.
"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," Wright added.