The US Food and Drug Administration (FDA) has approved ranibizumab injection (Lucentis, Genentech), 0.5 mg, for the treatment of myopic choroidal neovascularization (mCNV), the company has announced.
Ranibizumab is the first FDA-approved anti-vascular endothelial growth factor therapy for mCNV.
The approval was based on results of the phase 3 RADIANCE study, a randomized, double-masked, active-controlled study comparing the efficacy and safety of ranibizumab against verteporfin photodynamic therapy (vPDT) in 276 patients with visual impairment due to mCNV.
The study demonstrated that treatment with ranibizumab (0.5 mg) provided superior visual acuity gains compared with vPDT. At 3 months, average visual acuity gains for patients treated with ranibizumab were more than 12 letters, compared with 1.4 letters for those treated with vPDT. Adverse events were similar to those seen in other trials of ranibizumab.
Affecting an estimated 41,000 people in the United States, mCNV is a vision-threatening complication of pathologic myopia.
"Myopic choroidal neovascularization often strikes adults in the prime of their lives, and can lead to severe vision loss or blindness," Sandra Horning, MD, Genentech chief medical officer and head of global product development, said in a news release.
"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," she said.
In addition to mCNV, ranibizumab is FDA-approved for the treatment of patients with wet age-related macular degeneration, macular edema after retinal vein occlusion, diabetic macular edema, and diabetic retinopathy in people with DME. Its safety and efficacy have been studied in more than 9000 patients, across 9 pivotal and 24 clinical trials, the company notes.
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Cite this: FDA Clears Ranibizumab for Myopic Choroidal Neovascularization - Medscape - Jan 06, 2017.
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