FDA approves prefilled ranibizumab syringe for DR

Genentech announced the approval of a single-use syringe prefilled with 0.3 mg of ranibizumab for treating all forms of diabetic retinopathy (DR), with or without diabetic macular edema (DME).

Made from borosilicate glass, the prefilled syringes are packaged in a sterile, sealed tray and allow physicians to eliminate several steps in preparing and administering ranibizumab. Physicians will not need to draw the medicine from a vial, disinfect the vial or attach a filter needle. Genentech expects the syringes to be available in the second quarter of 2018.

The FDA previously approved a single-use 0.5-mg ranibizumab prefilled syringe for treating wet AMD, myopic choroidal neovascularization and macular edema secondary to retinal vein occlusion

“Diabetic retinopathy is a serious condition that affects millions of people in the U.S.,” said Sandra Horning, MD, 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.”