03.21.18

FDA Approves Lucentis 0.3 mg Prefilled Syringe for Diabetic Macular Edema and Diabetic Retinopathy

Source: Genentech

Genentech announced that the FDA has approved the Lucentis (ranibizumab) 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 FDA-approved medicine to treat all forms of diabetic retinopathy in people with or without diabetic macular edema (DME). Diabetic retinopathy is the leading cause of blindness among working age adults and affects nearly 7.7 million people in the U.S. The Lucentis 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.

“Diabetic retinopathy is a serious condition that affects millions of people in the U.S.,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a company news release. “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 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 Lucentis PFS, physicians snap off the syringe cap, attach the injection needle to the syringe and adjust the dose prior to administration.

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

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

Related Content