FDA has expanded the approved use of ranibizumab (Lucentis, Genentech) to treat diabetic retinopathy in patients with diabetic macular edema (DME).
Diabetic retinopathy (DR) is a disorder of the retinal vasculature that occurs in patients with long-standing diabetes. Early on, DR is characterized by vascular occlusion and dilations and later can progress into DME, a condition in which fluid leaks into the center of the macula, the part of the eye where sharp, straight ahead vision occurs. The fluid makes the macula swell, causing blurred vision. In some cases of DR with DME, abnormal new blood vessels grow on the surface of the retina. If these blood vessels break, severe vision loss or blindness may occur.
Lucentis is a humanized monoclonal antibody fragment which inhibits human vascular endothelial growth factor A (VEGF-A) from binding to its receptors thereby suppressing the growth of new blood vessels in the eye and effectively slowing vision loss.
Lucentis is available as a once a month intravitreal injection and is only for use by ophthalmologists trained in the specialized administration techniques. It is intended to be used along with appropriate interventions to control blood sugar, blood pressure and cholesterol.
“Diabetes is a serious public health crisis, affecting more patients every year,” said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in 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.”
Lucentis was granted breakthrough therapy designation for the treatment of DR with DME, indicating that the drug may demonstrate a substantial improvement over available therapies for patients with serious conditions. The drug was also approved under the FDA’s priority review program, which provides an expedited review of drugs with the potential to be a significant improvement in the safety or effectiveness in the treatment of a serious condition.
The drug’s safety and efficacy in the treatment of DR with DME were established in 2 clinical trials involving 759 participants who were treated and followed for 3 years. In both studies, participants treated with Lucentis showed significant improvement in the severity of their DR at 2 years compared to patients who did not receive the drug.
The most common side effects associated with the use of Lucentis include bleeding of the conjunctiva, eye pain, floaters, and increased intraocular pressure. Serious side effects include infection within the eyeball and retinal detachment.
Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.