FDA Approves Genentech’s Lucentis (Ranibizumab) Prefilled Syringe

Source: Genentech

Friday, October 14, 2016 | Product Releases , Genentech


Genentech announced that the FDA approved the Lucentis (ranibizumab) 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,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a company news release. “With the PFS, physicians will have a new option for administering Lucentis to the hundreds of thousands of people in the US 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 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.


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