JAN 06, 2017
The FDA has approved intravitreal ranibizumab (Lucentis) for treatment of myopic choroidal neovascularization (mCNV).
Currently approved for 4 other indications in the US, ranibizumab is the first anti-VEGF agent FDA approved for mCNV.
Approval was based on results from a phase 3 trial that demonstrated mCNV patients receiving ranibizumab (0.5 mg) showed superior visual gains at 3 months compared with those receiving verteporfin photodynamic therapy (vPDT) (12 letters vs. 1.4).
“Myopic choroidal neovascularization often strikes adults in the prime of their lives, and can lead to severe vision loss or blindness,” said Sandra Horning, MD, Genentech’s chief medical officer and head of global product development. “With Lucentis, people with this condition now have a new FDA-approved treatment option that has been shown to provide a significant improvement in vision in a clinical study.”
Myopic choroidal neovascularization is a rare disease that typically presents in severely near-sighted individuals between ages 45 and 64. Previous treatments, including vPDT, laser photocoagulation and surgery may help stabilize vision but often cannot improve it.