Phase III trials showed that antibody improves visual acuity rather than just stabilizing disease.
The EC has cleared Novartis’ intraocular antibody therapy Lucentis® (ranibizumab injection) for the treatment of visual impairment caused by diabetic macular edema (DME). Approval was granted on the basis of two trials, Restore and Resolve, which showed that injection of the VEGF-neutralizing antibody-fragment either as monotherapy or in combination with standard of care laser therapy was more effective than laser treatment alone at improving visual acuity.
Novartis points out that while laser therapy can provide stabilization of vision in DME patients, it generally doesn’t improve vision. In contrast, Lucentis is the first therapy licensed to improve both vision and vision-related quality of life.
Lucentis is separately available in over 85 countries, including Europe, for the treatment of wet age-related macular degeneration (wet AMD). The drug has been developed for the U.S. market by Genentech, where it is approved for the treatment of wet AMD, and macular edema following retinal vein occlusion (RVO). The firm is also carrying out two Phase III studies, Rise and Ride, in patients with DME. It says these results are expected in 2011. Novartis has exclusive rights to develop Lucentis in the rest of the world, and has filed for European approval of the drug in the treatment of visual impairment due to macular edema secondary to RVO.
Novartis reported Lucentis sales of $398 million in the third quarter of 2010 (to September 30), up 22% at constant currency rates. Sales over the first nine months of 2010 were $1,139 million, up 30%. Although Novartis doesn’t market Lucentis in the U.S., the drug was still its third best-selling pharmaceutical in the third quarter of 2010 and the full nine-months period, behind the hypertension drug Diovan/Co-Diovan, and the chronic myeloid leukemica therapy Gleevec/Glivec.
U.S. sales of Lucentis by Genentech, meanwhile, reached $697 million in the first half of 2010 (to June 30), up 27% in local currency on the previous year’s first half, according to parent firm Roche. Lucentis was Roche’s 8th best-selling drug during the 2010 period, even though Genentech only markets the treatment in the U.S.