FDA approves lucentis to treat diabetic retinopathy

By Caribbean Medical News Staff
The most common eye disease among diabetics is called Diabetic Retinopathy (DR) which usually leads to blindness in adults in the United States.
According to the Centre for Disease Control and Prevention (CDC), diabetes (type 1 and type 2) affects more than 29 million people in the United States and is the leading cause of new blindness among people ages 20 to 74 years.
These statistics led the U.S. Food and Drug Administration (FDA) to take swift action and expand the approved use for Lucentis (ranibizumab injection) 0.3 mg to treat diabetic retinopathy (DR) in patients with diabetic macular oedema (DME). The drug is administered as an injection into the eye once a month. It is intended to be used in conjunction with the appropriate diabetic protocols: controlling cholesterol, blood sugar and blood pressure.
Two clinical studies were done involving 759 participants who were treated and monitored for three years. The studies were done in order to determine the drug’s safety and efficacy to treat patients with DR. In the two studies, participants being treated with Lucentis showed significant improvement in the severity of their DR at two years compared to patients who did not receive the medication.
Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Centre for Drug Evaluation and Research said: “Diabetes is a serious public health crisis, affecting more patients every year. Today’s approval gives patients with diabetic retinopathy and diabetic macular oedema the first significant therapy to treat this vision-impairing complication.”
Previously, the FDA had approved Lucentis to treat DME and macular oedema secondary to retinal vein occlusions, both of which cause fluid to leak into the macula resulting in blurred vision. Lucentis is also approved to treat wet (neovascular) age-related macular degeneration (AMD), a condition in which abnormal blood vessels grow and leak fluid into the macula.
Some common side effects may include: bleeding of the conjunctiva, the tissue that lines the inside of the eyelids and covers the white part of the eye; eye pain; floaters; and increased pressure inside the eye (intraocular pressure). Serious side effects include infection within the eyeball (endophthalmitis) and retinal detachments. People experiencing any of these side effects are urged to contact their physician.