FDA approved prefilled syringe version of Lucentis for diabetic retinopathy

The US Food and Drug Administration (FDA) has approved Genetech’s Lucentis (ranibizumab injection) 0.3 mg prefilled syringe as a new administration method for the treatment of all forms of diabetic retinopathy (DR) in patients with diabetic macular oedema (DME).

“Diabetic retinopathy is a serious condition that affects millions of people in the US,” said Dr Sandra Horning, 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 prefilled syringe is made of borosilicate glass and packaged in a single-use sterile, sealed tray. It is the first syringe prefilled with an anti-vascular endothelial growth factor (VEGF) agent FDA-approved to treat both diabetic retinopathy and DME and is expected to be available in the second quarter of 2018.