Genentech announced that the Food and Drug Administration (FDA) has approved Lucentis (ranibizumab) injection 0.3mg prefilled syringe (PFS) as a new route of administration to treat all forms of diabetic retinopathy. The 0.3mg PFS marks the first approved syringe with an anti-vascular endothelial growth factor (VEGF) to treat all forms of diabetic retinopathy with or without diabetic macular edema (DME).
The 0.3mg PFS strength is made of broncosilicate glass and packaged in single-use tray, which cuts some steps in the preparation and administration process (disinfecting the vial, attaching a filter needle, drawing the medicine from the vial with the needle, removing the filter needle from the syringe, replacing with an injection needle). Clinicians can now snap off the syringe cap, attach the injection needle and adjust the dose prior to administration.
Lucentis is already available as 6mg/mL and 10mg/mL strength solutions for ophthalmic intravitreal injection in single-use vials and as prefilled syringes for the 10mg/mL strength. The 0.5mg PFS was approved in October 2016, for the treatment of neovascular age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV).
Lucentis 0.3mg PFS is anticipated to launch in the second quarter of 2018.
For more information call (800) 821-8590 or visit Lucentis.com.