Roche (SIX: RO, ROG; OTCQX: RHHBY) have announced the FDA approval of Lucentis (ranibizumab injection) 0.3mg for the treatment of diabetic macular edema (DME). The approval of the successful Genentech drug follows on from the results of two identically-designed parallel, double masked, sham treatment control Phase III trials (“RIDE” and “RISE”) conducted in a total of 759 patients. In their press release, Roche heralded the regulatory approval as the “first major treatment advance in more than 25 years for [the] sight-threatening condition” of DME.
Genentech / Roche obtain approval for Lucentis to treat DME
- by swdadmin