Genentech announced the FDA approved Lucentis for the treatment of myopic choroidal neovascularization, the fifth FDA-approved indication for the drug.
In the phase 3 RADIANCE study, Lucentis (ranibizumab) provided an average visual acuity gain of more than 12 letters for patients with myopic CNV after 3 months of treatment, compared with 1.4 letters for those treated with verteporfin photodynamic therapy. The randomized, double-masked, active-controlled study compared the safety and efficacy of ranibizumab and verteporfin PDT in 276 patients with myopic CNV, according to a company press release.
Patients in the study were randomized into three treatment groups: Two groups received ranibizumab injections guided by prespecified re-treatment criteria, and the third group received verteporfin PDT. Efficacy was comparable between the ranibizumab groups, and adverse events were similar to those in other ranibizumab trials, according to the release.
“With Lucentis, people with [myopic CNV] now have a new FDA-approved treatment option that has been shown to provide a significant improvement in vision in a clinical study,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in the release.
Lucentis was previously approved to treat wet age-related macular degeneration, macular edema after retinal vein occlusion, diabetic macular edema and diabetic retinopathy in patients with DME.