January 6, 2017
FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) for Myopic Choroidal Neovascularization
- First anti-vascular endothelial growth factor (VEGF) therapy approved to treat patients with myopic choroidal neovascularization (mCNV) in the U.S., a condition that can lead to blindness
- Myopic CNV is a complication of severe near-sightedness and most commonly affects people between ages 45 and 64
- Granted Priority Review by the FDA
- Fifth FDA-approved indication for Lucentis since its launch in 2006
South San Francisco, CA — January 5, 2017 —
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Lucentis® (ranibizumab injection) 0.5 mg for the treatment of patients with myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. Lucentis is the first FDA-approved anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV in the U.S. This is the fifth FDA-approved indication for Lucentis since the medicine was launched in 2006.
This approval is based on the results of the Phase III RADIANCE study, which demonstrated that treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy (vPDT). At three months, average visual acuity gains for patients treated with Lucentis were more than 12 letters, compared to 1.4 letters for those treated with vPDT.
“Myopic choroidal neovascularization often strikes adults in the prime of their lives, and can lead to severe vision loss or blindness,” said Sandra Horning, M.D., 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.”
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.1
Myopic CNV is believed to affect approximately 41,000 people in the U.S.2 and is a vision-threatening complication of pathological myopia or severe nearsightedness.1 People with pathological myopia, who are between the age of 45 and 64 are more likely to develop mCNV,2 and the condition affects more women than men.2
About the RADIANCE Study
RADIANCE is a Phase III, randomized, double-masked, active-controlled study comparing the efficacy and safety of Lucentis (0.5 mg) versus verteporfin photodynamic therapy (vPDT) in 276 patients with visual impairment due to myopic choroidal neovascularization (mCNV). Patients were randomized into three treatment groups: two groups of patients randomized to Lucentis received injections guided by pre-specified retreatment criteria and the third group received treatment with vPDT.
At month 3, the Lucentis groups I and II 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 over the vPDT group III, which had a mean BCVA change of +1.4 letters from baseline. The efficacy between groups I and II were comparable. Adverse events were similar to those seen in other Lucentis trials.