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Ranibizumab, a vascular endothelial growth factor, or VEGF inhibitor, has been approved to treat diabetic retinopathy in patients with diabetic macular edema, the Food and Drug Administration announced on Feb 6.
This approval “gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. A 0.3-mg dose is administered by intravitreal injection once a month (roughly every 28 days), according to the updated prescribing information.
Approval was based on two studies of 759 patients, which found that after 2 years of treatment, those treated with ranibizumab had significant improvements in the severity of diabetic retinopathy, compared with controls. Bleeding of the conjunctiva, eye pain, floaters, and increased intraocular pressure were the most common adverse effects associated with treatment; endophthalmitis and retinal detachments were the most serious adverse effects, according to the FDA.
Ranibizumab was first approved in 2006, for neovascular (wet) age-related macular degeneration, followed by diabetic macular edema, and macular edema following retinal vein occlusion. It is marketed as Lucentis, by Genentech, a member of the Roche group. “The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation,” according to the prescribing information.
Ranibizumab, a vascular endothelial growth factor, or VEGF inhibitor, has been approved to treat diabetic retinopathy in patients with diabetic macular edema, the Food and Drug Administration announced on Feb 6.
This approval “gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. A 0.3-mg dose is administered by intravitreal injection once a month (roughly every 28 days), according to the updated prescribing information.
Approval was based on two studies of 759 patients, which found that after 2 years of treatment, those treated with ranibizumab had significant improvements in the severity of diabetic retinopathy, compared with controls. Bleeding of the conjunctiva, eye pain, floaters, and increased intraocular pressure were the most common adverse effects associated with treatment; endophthalmitis and retinal detachments were the most serious adverse effects, according to the FDA.
Ranibizumab was first approved in 2006, for neovascular (wet) age-related macular degeneration, followed by diabetic macular edema, and macular edema following retinal vein occlusion. It is marketed as Lucentis, by Genentech, a member of the Roche group. “The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation,” according to the prescribing information.
Ranibizumab, a vascular endothelial growth factor, or VEGF inhibitor, has been approved to treat diabetic retinopathy in patients with diabetic macular edema, the Food and Drug Administration announced on Feb 6.
This approval “gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. A 0.3-mg dose is administered by intravitreal injection once a month (roughly every 28 days), according to the updated prescribing information.
Approval was based on two studies of 759 patients, which found that after 2 years of treatment, those treated with ranibizumab had significant improvements in the severity of diabetic retinopathy, compared with controls. Bleeding of the conjunctiva, eye pain, floaters, and increased intraocular pressure were the most common adverse effects associated with treatment; endophthalmitis and retinal detachments were the most serious adverse effects, according to the FDA.
Ranibizumab was first approved in 2006, for neovascular (wet) age-related macular degeneration, followed by diabetic macular edema, and macular edema following retinal vein occlusion. It is marketed as Lucentis, by Genentech, a member of the Roche group. “The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation,” according to the prescribing information.
