The U.S. Food and Drug Administration (FDA) has approved Lucentis (ranibizumab injection) for the treatment of a condition called macular edema that occurs after another blinding condition known as retinal vein occlusion (RVO). RVO is a leading cause of blindness in elderly people. The FDA approval comes after review of the results from two major clinical trials showing significant improvement in vision in patients with RVO who receiving Lucentis. People treated with monthly Lucentis injections showed sustained vision improvement during the 6-month study. The beneficial effects were seen as early 1 week after start of treatment in some patients.
The two studies, called BRAVO and CRUISE compared changes in best-corrected visual acuity (BCVA)—a key vision indicator—at 6 months in patients who received Lucentis or sham injections (placebo). In the BRAVO study, 61% of patients in the Lucentis arm gained 15 or more letters in BCVA at 6 months, compared with 29% in the placebo arm. In the CRUISE study, 48% and 17% of patients experienced improvement in the Lucentis and placebo arms, respectively. No new safety events were observed in either study.
RVO affects more than 1 million people in the United States, and is the second-most common cause of vision loss due to retinal vascular disease, which can develop over a long period of time or occur suddenly. RVO occurs when the normal blood flow through a retinal vein becomes blocked, causing swelling (edema) and hemorrhages in the retina, which may result in vision loss.
Lucentis inhibits a key protein, vascular endothelial growth factor (VEGF), involved in new blood vessel growth (angiogenesis). In RVO, the proliferation of leaky capillaries behind the retina lead to swelling and thickening of the macula, which is the portion of the eye responsible for fine, detailed central vision. Inhibiting the growth of these tiny blood vessels reduces swelling of the macula, leading to improvement in vision.