The US Food and Drug Administration (FDA) approved Lucentis (ranibizumab injection) for treating diabetic eye disease, known as diabetic macular edema (DME), which can cause blindness in people with diabetes.
For diabetics with good sugar control, Lucentis is administered once a month as an injection into the eye. This drug had previously received FDA approval as a treatment for certain types of age-related macular degeneration.
The FDA reviewed two clinical studies, RIDE and RISE. Each tested the safety and effectiveness of Lucentis as a treatment for diabetic macular edema. In the studies, patients who received doses of 0.3 mg of Lucentis for 24 months were able to read more lines and letters on an eye chart than those in the control group.
Researchers observed significant improvements in macular edema. Further, retinopathy (damage to the retina) was more likely to improve for patients treated with ranibizumab, and these patients were less likely to undergo macular laser procedures.
Based on these studies, researchers concluded that Lucentis improves vision and reduces the risk of further vision loss for patients with DME, with low rates of side effects.
The most commonly reported side effects for patients who received the drug included: headaches, dry or itchy eyes, teary eyes, a feeling that something was in the eye, nausea and back pain.