Lucentis returns positive results from DME trial
Genentech has released positive results from its Phase III ‘Rise’ trial of Lucentis (ranibizumab) for the treatment of diabetic macular edema (DME), which causes swelling of the retina and can lead to blindness. The company, a wholly owned subsidiary of Swiss drug maker Roche, says the drug provided ‘rapid and sustained improvement in vision’ compared with placebo. Swelling in the retina was reduced, and patients were able to read more easily. The results were presented at the 34th annual meeting of the Macula Society in Florida, US.
After 24 months, 45 per cent of patients (56 out of 125) given 0.3mg doses of Lucentis could read at least 15 additional letters on the eye chart than they were able to at the start of the study, compared with 18 per cent of patients (23 out of 127) given placebo. But – as seen in previous trials – patients in the Lucentis group were more prone to certain side-effects, the most serious of which were infection, tearing of the retina and cataracts caused by trauma.
The results follow the recent decision by the UK National Institute for Health and Clinical Excellence (Nice) to withhold recommendation of Lucentis for the treatment of DME in the first draft of its guidance. Nice assesses drugs on behalf of the UK National Health Service, taking into consideration their cost. Lucentis is vascular endothelial growth factor (VEGF) inhibitor approved for the treatment of age-related macular degeneration (AMD) and other eye conditions. In Europe, it is marketed by Novartis. (more…)