Roche's blockbuster Lucentis nabs fourth FDA approval
- In addition to its other three indications, Lucentis is now FDA-approved for the treatment of diabetic retinopathy (DR) in patients with diabetic macular edema (DME).
- For this indication, Lucentis is injected once monthly and is intended to be used in conjunction with lifestyle and other pharmacolgic interventions to control blood sugar.
- Phase 3 studies involve 79 patients with DME, treated over a two-year period. Patients with DME treated with Lucentis saw significant improvements in their DR, comapred with those not treated with Lucentis.
No doubt about it, Lucentis is a bona fide contributor to Roche's bottom line, with 1.84 billion in sales for the fourth quarter of 2014. In 2012, when it became the first drug approved for treatment of DME, Lucentis had already racked up two other approvals, including wet age-related macular degeneration in 2006 and macular edema in 2010. The underlying mode of action that drives its therapeutic value is inhibition of vascular endothelial growth factor.