Genentech has secured approval from the US Food and Drug Administration (FDA) for its Lucentis (ranibizumab injection) 0.5mg prefilled syringe (PFS) as a new method of administering the medicine.
Similar to the Lucentis 0.5 mg vial, the 0.5mg PFS has been approved to treat people with wet age-related macular degeneration (AMD) and macular edema after retinal vein occlusion (RVO).
Lucentis PFS is claimed to be the first syringe prefilled with an anti-VEGF medicine FDA-approved to treat two eye conditions.
The PFS enables physicians to avoid various steps in the preparation and administration process.
The steps that can be eliminated include 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.
Lucentis PFS also helps physicians to attach the injection needle to the syringe and adjust the dose prior to administration.
The company plans to commercialize the Lucentis 0.5 mg PFS in early 2017.
Genentech global product development head and chief medical officer Dr Sandra Horning said: “The FDA approval of the Lucentis prefilled syringe marks a new milestone in our ongoing commitment to people affected by vision-threatening eye diseases.
“With the PFS, physicians will have a new option for administering Lucentis to the hundreds of thousands of people in the U.S. diagnosed with either wet AMD or macular edema after RVO.”