Genentech's Lucentis gets FDA approval for use in the treatment of wet AMD

US biotechnology firm Genentech says that the Food and Drug Administration has approved Lucentis (ranibizumab injection) for the treatment of neovascular (wet) age-related-macular degeneration. The product, which is a humanized immunoglobulin G1 kappa isotype antibody, was developed in collaboration with Swiss major Novartis and is designed to inhibit the activity of human vascular endothelial growth factor (VEGF), which is thought to play a critical role in the angiogenesis.

Lucentis maintains and improves vision

The approval is based on data from two pivotal Phase III studies, MARINA and ANCHOR (Marketletter July 25, 2005), which showed that monthly treatment, 0.5mg administered via intraocular injection, allowed 95% of those treated with the biologic to maintain their visual acuity (measured using the Early Treatment of Diabetic Retinopathy eye chart), compared with 62.2% of the control group who received a sham injection.