Genentech, a member of the Roche Group recently announced that the U.S. Food and Drug Administration (FDA) approved Lucentis® (ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy. The most common cause of vision loss in people with diabetes, diabetic retinopathy is the leading cause of blindness among adults aged 20 to 74 and affects nearly 7.7 million people in the U.S. With this approval, Lucentis becomes the first and only FDA-approved medicine to treat diabetic retinopathy in people who have been diagnosed either with or without diabetic macular edema (DME), a complication of diabetic retinopathy that causes swelling in the back of the eye.
The FDA granted Lucentis Priority Review for the treatment of diabetic retinopathy without DME based on an analysis of the Diabetic Retinopathy Clinical Research Network’s Protocol S study. This NIH-funded study compared Lucentis treatment to panretinal laser treatment in diabetic retinopathy patients both with and without DME. In the analysis that supported this approval, patients with and without DME in the Lucentis group experienced improvements in the severity of their retinopathy. Adverse events were consistent with those seen in previous studies.
“Diabetic retinopathy is the leading cause of vision loss among working-aged adults in the U.S. between the ages of 20 and 74. We are very pleased that Lucentis is now FDA-approved to treat retinopathy in people with and without DME,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “In multiple clinical studies, Lucentis demonstrated a significant improvement of patients’ diabetic retinopathy, and it is the first and only anti-VEGF therapy approved to treat all forms of diabetic
retinopathy.”
Priority Review Designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. The FDA previously granted Lucentis Breakthrough Therapy Designation for diabetic retinopathy in 2014 based on the pivotal RIDE and RISE Phase III clinical trials. Breakthrough designation is intended to expedite the development and review of medicines with early evidence of potential clinical benenfit in serious diseases and to help ensure that patients receive access to medicines as soon as possible.
The longer a person has diabetes, especially if it is poorly controlled, the higher the risk of developing diabetic retinopathy and vision loss. Diabetic retinopathy occurs when blood vessels in the retina become damaged. This can cause vision loss or distortion when the abnormal vessels leak blood or fluid into the eye.
About Lucentis
Lucentis is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.
Lucentis is FDA-approved for the treatment of patients with wet age-related macular degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy and myopic choroidal neovascularization (mCNV).
Outside the U.S., Lucentis is approved in more than 110 countries to treat patients with wet AMD, for the treatment of DME, and due to macular edema secondary to both branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO) and visual impairment due to choroidal neovascularization (CNV).
Lucentis important safety information
Patients should not use Lucentis if they have an infection in or around the eye or are allergic to Lucentis or any of its ingredients. Lucentis is a prescription medication given by injection into the eye and it has side effects. Some Lucentis patients have had detached retinas and serious infections inside the eye. If the eye becomes red, sensitive to light, or painful, or if there is a change in vision, patients should call or visit an eye doctor right away.
Some patients have had increased eye pressure before and within one hour of an injection.
Uncommonly, Lucentis patients have had serious, sometimes fatal problems related to blood clots, such as heart attacks or strokes. Fatal events were seen more often in patients with diabetic macular edema and diabetic retinopathy with Lucentis compared with patients who did not receive Lucentis. Serious side effects include inflammation inside the eye and, rarely, problems related to the injection procedure such as cataracts. These side effects can make vision worse. The most common eye-related side effects are increased redness in the white of the eye, eye pain, small specks in vision and increased eye pressure. The most common non-eye-related side effects are nose and throat infections, headache, lung/airway infections, and nausea.
Source: drugs.com