Genentech announced the U.S. Food and Drug Administration (FDA) approved the Lucentis (ranibizumab injection) 0.3 mg prefilled syringe (PFS) as a new method of administering the medicine to treat all forms of diabetic retinopathy. In April 2017, Lucentis 0.3 mg became, and remains, the first and only FDA-approved medicine to treat all forms of diabetic retinopathy in people with or without diabetic macular edema (DME), a complication of the eye disease that causes swelling in the back of the eye. Diabetic retinopathy is the leading cause of blindness among working age adults and affects nearly 7.7 million people in the U.S. The Lucentis 0.3 mg PFS is now the first syringe prefilled with an anti-vascular endothelial growth factor (VEGF) agent FDA-approved to treat both diabetic retinopathy and DME.
“Diabetic retinopathy is a serious condition that affects millions of people in the U.S.,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Today’s approval of the Lucentis 0.3 mg prefilled syringe reinforces our commitment to advancing therapy for those impacted by this vision-threatening disease.”
The Lucentis 0.3 mg PFS, which is made of borosilicate glass and is packaged in a single-use sterile, sealed tray, allows physicians to eliminate several steps in the preparation and administration process, including disinfecting the vial, attaching a filter needle, drawing the medicine from the vial using the needle, removing the filter needle from the syringe and replacing with an injection needle. With the Lucentis PFS, physicians snap off the syringe cap, attach the injection needle to the syringe and adjust the dose prior to administration.
The Lucentis 0.3 mg PFS is expected to be available in the second quarter of 2018.
The Lucentis 0.5 mg PFS, FDA-approved in October 2016, is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV).
Diabetic retinopathy is the most common cause of vision loss in people with diabetes, which affects approximately 30 million people in the U.S. 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.
Diabetic macular edema (DME), which affects approximately 750,000 people in the U.S., is one of the vision-threatening complications of diabetic retinopathy, in which chronic damage occurs to the fine blood vessels of the retina, the light-sensitive tissue at the back of the eye necessary for good vision.
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 following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV).
Lucentis was developed by Genentech, a member of the Roche Group. The company retains commercial rights in the U.S. and Novartis has exclusive commercial rights for the rest of the world.
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).