Swiss drug maker Novartis has received broader approval from the European Commission for eye drug Lucentis, which is used to treat patients with visual impairment caused by diabetic macular oedema.
Lucentis is the first licensed therapy to significantly improve vision in patients with visual impairment due to diabetic macular oedema.
Approval was based on data from two Novartis-sponsored clinical trials, RESTORE and RESOLVE, which showed that Lucentis was superior in providing rapid and sustained visual acuity gain versus sham (dummy) therapy or laser therapy, the current standard of care.
Gabriele E Lang, a professor at University of Ulm, University Eye Hospital in Germany, said that Lucentis-treated patients began to recover their vision eight days after the first injection on average, and vision improvement was maintained at one year.
"The vision improvement for many of these patients was clinically significant, meaning that they regained the ability to carry out day-to-day activities such as driving," Lang said.
Lucentis is currently licensed in more than 85 countries for the treatment of wet age-related macular degeneration.