Novartis announced that first results of the RESTORE Phase III study show that ranibizumab is significantly more effective than laser treatment, the current standard of care, at treating visual impairment due to diabetic macular edema (DME), a serious complication of diabetes. The one year results show that 37% of patients treated with ranibizumab 0.5 mg alone, and 43% of those treated with ranibizumab plus laser therapy, gained a substantial vision improvement of 10 letters or more on an eye-chart compared to 16% of patients treated with laser alone.
Ranibizumab works by neutralizing a protein called vascular endothelial growth factor (VEGF), which is believed to cause abnormal blood vessel growth and leakage beneath the macula.
Ranibizumab has been approved in more than 80 countries for the treatment of wet age-related macular degeneration (AMD) under the brand name Lucentis®. It is not currently licensed in any market for the treatment of visual impairment due to DME. An application for marketing approval in this indication was submitted to EU health authorities in December 2009.