The European Medicines Agency approved a new indication for Novartis’ Lucentis® (ranibizumab) as a treatment for patients with visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO and central RVO). Approval was based on data from two pivotal Phase III studies, BRAVO in BRVO patients, and CRUISE in CRVO patients, which confirmed that treatment using Lucentis resulted in early and sustained improvement in vision at six months.
The BRAVO study showed that some 60% of BRVO patients treated with monthly Lucentis gained at least 15 letters of visual acuity at six months, compared with 29% of participants treated according to current standard practice. Forty-eight percent of Lucentis-treated CRVO patients in the CRUISE study gained at least 15 letters of visual acuity at six months compared with just 17% of those in the control cohort.
Lucentis is an antibody fragment targeting VEGF. The drug is currently approved in some 85 countries for the treatment of age-related macular degeneration and in over 30 countries for treating visual impairment due to diabetic macular edema. Genentech has commercial rights to the drug in the U.S. Lucentis is already approved in the U.S. for the treatment of macular edema following RVO. Novartis retains exclusive rights to the drug in the rest of the world.