BRIEF — US approval for pre-filled syringe 0.3mg dosage of Lucentis

The US Food and Drug Administration (FDA) has approved the Lucentis (ranibizumab injection) 0.3mg prefilled syringe (PFS) as a new method of administering the medicine to treat all forms of diabetic retinopathy.

In April 2017, Lucentis 0.3mg became, and remains, the first and only FDA-approved medicine to treat all forms of diabetic retinopathy in people with or without diabetic macular edema (DME), a complication of the eye disease that causes swelling in the back of the eye.

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.

PFS options are now FDA-approved for all Lucentis indications.

Lucentis was developed by Genentech, a member of the Roche group. The company retains commercial rights in the USA and Novartis has exclusive commercial rights for the rest of the world.