The US Food and Drug Administration (FDA) has cleared Genentech's Lucentis 0.3mg (ranibizumab injection), a recombinant humanised monoclonal antibody fragment (lacking an Fc region) designed to treat diabetic macular edema (DME).
The approval of Lucentis in DME was based on Genentech's parallel, double-masked, three-year Phase III RIDE and RISE trials, which were sham-treatment controlled for 24 months.
A total of 759 patients were randomised into three groups to receive monthly treatment with 0.3mg Lucentis (n=250), 0.5mg Lucentis (n=252) or sham injection (control group, n=257).
Lucentis 0.5mg once monthly was approved by the FDA for treatment of wet age-related macular degeneration (AMD) in 2006 and for macular edema following retinal vein occlusion (RVO) in 2010, according to the company.
The results demonstrated that patients who received 0.3mg Lucentis experienced significant, early (day seven) and sustained (24 months) improvements in vision.
Vision improvements observed in patients treated with Lucentis at 24 months were maintained with continued treatment through 36 months.
Pooled safety analysis of RIDE and RISE at 24 months showed that the ocular safety of Lucentis in patients with DME was generally consistent with that established in patients with wet AMD and RVO (through 36 months).
The rate of arteriothromboembolic events at 36 months was 10.8% for patients in the 0.3mg treatment group (control period ended at 24 months), while the rate of stroke in DME patients at 24 months was 1.2%, 0.3mg versus 1.6%, control. At 36 months the rate of stroke was 2% for this treatment group.
Genentech chief medical officer and global product development head Hal Barron said, "We developed Lucentis to treat diseases of the eye and are pleased to have received this third US indication to help a new population of people whose eyesight may be affected by diabetes."