Lucentis, a vascular endothelial growth factor (VEGF) inhibitor, was first approved by the US Food and Drug Administration for the treatment of neovascular (wet) age-related macular degeneration (AMD) in June 2006.
It was also approved by the FDA for macular edema following retinal vein occlusion (RVO) on June 2010.
Lucentis was approved in 2011 for treatment of visual impairment due to DME in Europe, where it is marketed by Novartis.
The multicentre, randomized, double-masked, sham injection-controlled, Phase III study was designed to assess the efficacy and safety profile of Lucentis in 382 patients with DME.
The primary endpoint of the study revealed that after 24 months, a significantly greater number of patients who received Lucentis were able to read 15 additional letters on an eye chart than they could at the beginning of the study, compared to those who received placebo (sham) injections.
At 24 months, 33.6% of patients who received 0.3mg Lucentis and 45.7% of patients who received 0.5mg Lucentis were able to read 15 more letters on the eye chart than they could read at the start of the study, compared to 12.3% of patients who received sham injections.
Genentech said the key secondary endpoints, which included average eye chart reading scores over time and changes in retinal swelling, met statistical significance.
The safety results were consistent with previous Lucentis Phase III trials and no new significant safety findings were observed.