FDA Approves Lucentis for Myopic Choroidal Neovascularization

Source: Genentech

Thursday, January 05, 2017 | FDA Approval/Clearance , Genentech


Genentech announced that the FDA has approved Lucentis (ranibizumab) 0.5 mg for the treatment of patients with myopic choroidal neovascularization (mCNV). Lucentis is the first FDA-approved anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV in the United States, according to a company news release. 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 3 RADIANCE study, which demonstrated that treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy (vPDT). At 3 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,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in the 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.”

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.

About the RADIANCE Study

RADIANCE is a phase 3, 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 prespecified retreatment criteria and the third group received treatment with vPDT.

At month 3, the Lucentis groups 1 and 2 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 1 and 2 were comparable. Adverse events were similar to those seen in other Lucentis trials.

 


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