An exciting new treatment is about to hit the market for those with diabetic retinopathy (DR). The U.S. Food and Drug Administration has approved a drug called Lucentis to treat DR in patients with diabetic macular edema (DME). This is the first treatment approved in the United States for patients with DR and DME.
DME is a buildup of fluid in the macula—part of the retina that provides most of our detailed vision abilities—because of leaking blood vessels. Those that have DME also have DR, a disease in which the blood vessels in the retina are damaged, resulting in vision impairment.
Diabetic retinopathy is the most common eye disease in diabetics. According to the Centers for Disease Control and Prevention, DR is “the leading causes of blindness in adults.”
Because of DR’s rising rate and the added complication of DME, doctors, patients and pharmaceutical companies alike want to find a treatment that works.
Lucentis works in treating DR with DME by slowing the creation of new, mal-shaped blood vessels. In studies leading to the drug’s approval, participants showed significant improvement in the severity of their DR and had ideal high visual acuity after two years of injections. Lucentis was administered to the participants via an injection into the eye once a month from a doctor.
Because of the success for these clinical trials, the FDA granted Lucentis “breakthrough therapy designation” and “priority review,” which indicates that the clinical evidence demonstrated substantial improvement in the treatment of DR with DME.
“Diabetes is a serious public health crisis, affecting more patients every year,” commented Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication.”
The use of Lucentis comes with some caveats, however. The drug should be used alongside interventions to control blood sugar, blood pressure and cholesterol, to stall DR and improve vision. In addition, common side effects include eye pain, floaters, bleeding of the conjunctiva and increased eye pressure. Serious possible side effects are infection in the eyeball and retinal detachments.
Lucentis has previously been approved to treat macular edema following retinal vein occlusions (RVO) and wet age-related macular degeneration (wet AMD). It was also the first drug to be approved for treating DME. “While there are various options for treating diabetic macular edema, before today none were approved showing improvement in retinopathy,” explained Dr. Sandra Horning, chief medical officer at Roche, the Swiss pharmaceutical company behind Lucentis.
Lucentis can treat the original source of the problem, the DR itself. Hopefully with this new medication available, we will see increased vision abilities in those with diabetes.