FDA approves Genentech’s Lucentis (Ranibizumab injection) prefilled syringe
First anti-VEGF prefilled syringe FDA-approved to treat people with wet age-related macular degeneration and people with macular edema after retinal vein occlusion
November 22, 2016
By Tan Hui Wen
Genentech, a member of the Roche Group, recently announced that the U.S. Food and Drug Administration (FDA) approved the Lucentis (ranibizumab injection) 0.5 mg prefilled syringe (PFS) as a new method of administering the medicine. Like the Lucentis 0.5 mg vial, the 0.5 mg PFS is approved to treat people with wet age-related macular degeneration (AMD) and macular edema after retinal vein occlusion (RVO). The Lucentis PFS is the first syringe prefilled with an anti-VEGF medicine FDA-approved to treat two eye conditions.
“The FDA approval of the Lucentis prefilled syringe marks a new milestone in our ongoing commitment to people affected by vision-threatening eye diseases,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “With the PFS, physicians will have a new option for administering Lucentis to the hundreds of thousands of people in the U.S. diagnosed with either wet AMD or macular edema after RVO.”
The Lucentis PFS 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 can immediately attach the injection needle to the syringe and adjust the dose prior to administration.
The Lucentis 0.5 mg PFS is expected to be available in early 2017.