FDA Approves New Indication for Eye Drug Lucentis

Fifth agency nod since drug’s 2006 launch

The FDA has approved ranibizumab (Lucentis, Genentech) 0.5-mg injection for the treatment of patients with myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. Ranibizumab is the first FDA-approved anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV in the United States. This is the fifth FDA-approved indication for ranibizumab since the medication was launched in 2006.

Ranibizumab is designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in angiogenesis and in the hyperpermeability (leakiness) of the vessels.

In the U.S., ranibizumab is approved for the treatment of patients with wet age-related macular degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy in people with DME, and myopic choroidal neovascularization (mCNV). The safety and efficacy of ranibizumab have been studied in more than 9,000 patients in nine pivotal and 24 clinical trials.

The new FDA approval was based on results from the phase 3, randomized, double-blind, active-controlled RADIANCE trial, which compared the efficacy and safety of ranibizumab injection (0.5 mg) with that of verteporfin photodynamic therapy (vPDT) in 276 patients with visual impairment due to mCNV. The patients were randomly assigned to three treatment groups: two groups of patients received ranibizumab injections guided by prespecified retreatment criteria, and the third group received treatment with vPDT.

At month 3, the two ranibizumab groups had a mean change in best-corrected visual acuity (BCVA) of +12.1 and +12.5 letters from baseline, respectively, demonstrating a statistically significant improvement compared with the vPDT group, which had a mean BCVA change of +1.4 letters from baseline.

Pathological myopia causes the eye to grow too long from front to back, resulting in nearsightedness. In mCNV, new, abnormal blood vessels grow directly into the retina. These vessels may break and leak blood or fluid into the retina, which can cause irreversible central vision loss. Symptoms of mCNV include spots of central blurred or distorted vision, a sudden worsening of central vision, or difficulty distinguishing colors.

Approximately 41,000 people in the U.S. are believed to be affected by mCNV. People with pathological myopia who are between the ages of 45 and 64 are more likely to develop mCNV, and the condition affects more women than men.

Source: Genentech; January 5, 2017.

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