This article is more than 5 years old. Information may no longer be current.
FDA approves intravitreal ranibizumab for treatment of diabetic macular edema
Click Here to Manage Email Alerts
The U.S. Food and Drug Administration has approved the use of once-monthly 0.3-mg intravitreal ranibizumab for the treatment of diabetic macular edema, according to a press release from Genentech.
Lucentis (ranibizumab, Genentech) is the only medicine approved by the FDA for diabetic macular edema (DME), the release said.
The 0.3-mg dose of ranibizumab was unanimously recommended for approval on July 26 by the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee. Intravitreal ranibizumab has already been approved by the FDA for the treatment of wet age-related macular degeneration and macular edema following retinal vein occlusion.
In clinical trials, 759 patients were given a 0.3-mg dose of ranibizumab, a 0.5-mg dose of ranibizumab or a sham injection.
Patients who received the 0.3-mg dose demonstrated significant improvements in vision as soon as 7 days after treatment, with more ranibizumab-treated patients than control subjects experiencing an increase in vision of three lines or more by month 24, according to the release. Patients also experienced sustained visual acuity from baseline through 24 months, with continued treatment through 36 months.
The most common ocular adverse events associated with the 0.3-mg injection vs. the sham injection were conjunctival hemorrhage, eye pain, foreign body sensation in the eye, vitreous floaters and increased IOP.
“Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema,” Renata Albrecht, MD, director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA press release. “Today’s approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease.”
Perspective
Back to Top
Zachary T. Bloomgarden, MD, MACE
Vascular Endothelial Growth Factor (VEGF) antagonist treatment has found widespread use in the treatment of diabetic macular edema, based on the realization that angiogenesis is under control of a number of cytokines, the response to intravitreal steroids and to antibodies to VEGF both acting by this pathway. The development of new vessels with vascular leakage in the setting of ischemia, with neovascularization leading to production of fragile, structurally abnormal vascular pattern, underlies the pathogenesis of diabetic macular edema. Although laser photocoagulation is effective, it has the disadvantage of being destructive to the retina, particularly when used in the central vision area, while steroids are associated with cataract and glaucoma.
The FDA decision to approve ranibizumab further makes such treatment available, and should help the many thousands of persons with diabetes at risk of vision loss from this complication. Of course, the true long-term approach to treatment of diabetic macular edema is prevention by improving the treatment of diabetes. In an important sense, every person who requires laser treatment or intraocular medication represents a failure of medical care to deliver good and consistent glycemic control.
Perspective
Back to Top
John W. Kitchens, MD
“If you drain the Pacific Ocean, don’t be surprised to find that the islands are connected.” – Judah Folkman
Dr. Folkman’s statement is prophetic when it comes to vascular endothelial growth factor and disease of the eye.
Diabetes is the leading cause of new cases of blindness in people between the ages of 24 and 70 years. The impact of this disease on people in the prime of their working years is life-altering. Vision is a diabetic patient’s lifeline to not only their independence but also their ability to monitor and treat the very disease that robs them of vision.
It is astonishing that it has been more than 25 years since the last large randomized controlled trial, the Early Treatment Diabetic Retinopathy Study, that had a major impact on the way we approach diabetic retinopathy.
The U.S. Food and Drug Administration approval of Lucentis (ranibizumab, Genentech) for diabetic macular edema is based on the results of the Genentech-sponsored RIDE and RISE studies. These studies not only provided us with another option in the management of diabetic macular edema but also gave us insight into the dosing strategies, retinopathy progression and other important aspects of diabetic eye disease. One very important and often overlooked aspect of these studies is the effect that anti-VEGF therapy has on reducing the progression of retinopathy.
We have also seen impressive results in the Diabetic Retinopathy Clinical Research Network protocol I study. In the protocol I study, ranibizumab was compared with various other treatment modalities including combination therapy, combination therapy with steroids and laser alone. Additionally, the Diabetes Control and Complications Trial to the Early Treatment Diabetic Retinopathy Study produced strong results that have guided our ability to care for these individuals.
The same great man quoted at the beginning of this perspective also noted (about cancer): “We never use the word ‘cure’ because it is far away”. The same is true for ranibizumab. It is not a cure for diabetes or its effects on the eye. However, the FDA approval of ranibizumab for the treatment of diabetic macular edema provides a welcome addition to the arsenal of treatment options for our patients with diabetic macular edema.
Perspective
Back to Top
Stephen A. Brietzke, MD
It is always good to have new treatment options for difficult and sometimes insoluble clinical problems, and the FDA’s recent action to approve ranibizumab (Lucentis, Genentech) intravitreous injection for treatment of diabetic macular edema offers just that. This is a new FDA-approved indication for a drug originally approved for treatment of “wet” age-related macular degeneration in 2006. It is of interest that the United Kingdom’s National Institute for Clinical Excellence (NICE) declined to approve the drug for public funding and widespread use in the UK’s National Health Service, after due consideration 1 year ago, because of what it perceived as unacceptably high cost per quality-adjusted life year gained. In the US, that high cost will no doubt be an issue and doctor and patient acceptance of ranibizumab will likely hinge not only on financial cost, but on the acceptance of sticking a sharp object in the eye on a monthly basis. We should all follow our patients’ tales of tolerability of the treatment, and perceived improvement in vision, as we move forward with this new option in ocular disease treatment.
Click Here to Manage Email Alerts