Second Lucentis Ph III study meets primary endpoint for improved vision in DME patients

Swiss drug major Roche’s (SIX: ROG) subsidiary Genentech says that the second of two Phase III trials evaluating Lucentis (ranibizumab injection) in patients with diabetic macular edema (DME) met its primary endpoint.

Lucentis was approved for treatment of visual impairment due to DME in Europe (The Pharma Letter October 25, 2010). In the USA Lucentis was approved for treatment of neovascular (wet) age-related macular degeneration (AMD) in 2006 and more recently for treatment of macular edema following retinal vein occlusion (RVO) in June 2010. DME is a leading cause of blindness among the working-age population in most developed countries, and there are currently no US Food & Drug Administration approved medications to treat DME.

Fellow Swiss drug major Novartis holds rights to market Lucentis outside the USA. Lucentis, partly due to its high cost, has relatively modest sales, which EvaluatePharma forecasts will by around $1.49 billion for Roche and $1.94 billion for Novartis by 2016 (The Pharma Letter November 22, 2010).