Genentech’s Lucentis gets FDA approval for myopic choroidal neovascularization

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.

Global Product Development chief medical officer and head Sandra Horning, M.D. said: “Myopic choroidal neovascularization often strikes adults in the prime of their lives, and can lead to severe vision loss or blindness.

“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.

Myopic CNV is believed to affect approximately 41,000 people in the U.S. and is a vision-threatening complication of pathological myopia, or severe nearsightedness. People with pathological myopia who are between the age of 45 and 64 are more likely to develop mCNV, and the condition affects more women than men.