Genentech, a member of Roche Group, has obtained clearance for its Lucentis 0.3 mg (ranibizumab injection) from the US Food and Drug Administration (FDA).
Lucentis 0.3 mg is a recombinant humanized 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 randomized into three groups to receive monthly treatment with 0.3 mg Lucentis (n=250), 0.5 mg Lucentis (n=252) or sham injection (control group, n=257).
Lucentis 0.5 mg once monthly was approved by the FDA for treatment of wet age-related macular degeneration in 2006 and for macular edema following retinal vein occlusion in 2010, according to the company.
The results demonstrated that patients who received 0.3 mg Lucentis experienced significant, early (Day 7) 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).
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 U.S. indication to help a new population of people whose eyesight may be affected by diabetes."
