The European Commission has approved ranibizumab (Lucentis) for visual impairment due to choroidal neovascularization not associated with AMD or pathologic myopia.
The label expansion was based on the results of the Novartis sponsored MINERVA study, which investigated ranibizumab for of visual impairment due to CNV of idiopathic origin, or associated with uveitis, central serous chorioretinopathy, angioid streaks, trauma, tumor, and retinal or macular dystrophies.
The 12-month, double masked multicenter study randomized 178 patients to intravitreal ranibizumab (0.5 mg) or sham injection at baseline. Patients were followed monthly. At 2 months, treatment was provided as needed.
A significantly higher proportion of patients who received ranibizumab showed VA gains of ≥10 letters by month 2 compared to those given sham treatment, and results were maintained to month 12.
In addition, patients on ranibizumab displayed significantly greater rates of complete resolution of intraretinal or subretinal fluid. At month 6, patients who were able to cross-over to ranibizumab also showed anatomic and functional improvement
"With this approval, Lucentis is the only treatment available for a wide range of CNV conditions," said Novartis CEO Paul Hudson. “We are dedicated to bringing new innovations to the market, as we are aware that there is still high unmet medical need for patients with retinal diseases."
Lucentis is now the only treatment approved for this indication in the EU, applicable in all 28 member states as well as Iceland, Liechtenstein and Norway. According to the company, submissions for this indication have been filed in 11 other countries, including Switzerland, Australia, Indonesia and Brazil.