Lucentis®
(ranibizumab)
About Lucentis
Lucentis is an antibody fragment approved for the treatment of neovascular (wet) age-related macular degeneration (AMD). Lucentis is the only approved treatment for wet AMD proven to improve or maintain vision. Wet AMD is characterized by a loss of function in the portion of the eye responsible for central vision and is highly correlated with aging. Lucentis has become the “gold standard” for treating wet AMD and can be used at various intervention points in first-line and second-line therapy. Lucentis is marketed in the United States by Genentech and in the rest of the world by Novartis.
How Lucentis Works
Lucentis binds and inhibits vascular endothelial growth factor-A (VEGF-A), a protein critical to the formation of new, leaky blood vessels in the back of the eye that cause damage to the macula, which contains a high density of photoreceptors responsible for visual acuity.
Current Indications
Lucentis was approved for wet AMD in the US in 2006 and in the EU in 2007. Wet AMD is the leading cause of blindness in persons over 60 years of age in the developed world.
Current Clinical Trials of Lucentis
- Retinol vein occlusion (RVO)—On July 30, 2009 Roche announced that its Phase 3 CRUISE study showed Lucentis improved vision in patients with swelling in the retina (macular edema) due to central RVO. Central RVO is a common cause of vision loss that occurs when blood flow through a retinal vein becomes blocked, by a blood clot for example. On July 2, 2009, results of the Phase 3 BRAVO study were announced showing that Lucentis improved vision in patients with macular edema due to branch RVO. Roche has announced that it expects to file for approval of this new indication in 2010.
- Diabetic macular edema (DME)—DME occurs when the damaged blood vessels leak fluid and lipids onto the macula. The fluid makes the macula swell, which blurs vision. The Phase 3 RIDE and RISE trials are treating patients with Lucentis 0.5mg in 24 monthly injections versus a placebo. The Phase 2 READ-2 trial is treating patients with laser photocoagulation, Lucentis, or a combination of both. The Phase 2 LIME trial is comparing Lucentis versus focal laser treatment.