FDA Approves 0.3-mg Prefilled Syringe for Lucentis Administration

Option approved to treat all forms of diabetic retinopathy in people with or without diabetic macular edema

The FDA has approved the ranibizumab injection (Lucentis, Genentech) 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 ranibizumab 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.

The ranibizumab 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 ranibizumab PFS, physicians snap off the syringe cap, attach the injection needle to the syringe, and adjust the dose prior to administration.

The ranibizumab 0.3-mg PFS is expected to be available in the second quarter of 2018.

The ranibizumab 0.5-mg PFS, FDA-approved in October 2016, is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Source: Genentech; March 21, 2018.