Genentech files sBLA for Lucentis for diabetic retinopathy

Genentech, the biotech subsidiary of Swiss pharma major Roche (ROG: SIX), has submitted a supplemental Biologics License Application (sBLA) with the US Food and Drug Administrationfor Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy (DR).

DR is the most common diabetic eye disease and leading cause of new cases of blindness in working-age Americans, impacting nearly 7.7 million Americans. With no ocular medications currently approved for DR, this is the first of its kind submission, further demonstrating Genentech’s leadership and commitment to ophthalmology, the company stated.

Lucentis was the first FDA-approved medicine for diabetic macular edema (DME), a major cause of vision loss in people with diabetic retinopathy. It was approved in August 2012, and generated sales of 828 million Swiss francs ($915 million) for Roche in the first half of this year. Outside of the USA, Lucentis is marketed by fellow Swiss major Novartis (NOVN: VX).