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Novartis receives approval for new Lucentis indication
Novartis has been granted approval for Lucentis to be marketed in Europe as a treatment for visual impairment due to diabetic macular edema (DME).
The European commission has ratified the drug, which is already approved for use against wet age-related macular degeneration, based on positive data from the Restore and Resolve clinical trials.
Results from these studies have demonstrated that Lucentis can help to deliver better rates of rapid and sustained visual acuity improvement than either placebo or laser therapy, the current standard of care.
It represents the first licensed drug to deliver better vision and vision-related quality of life to DME sufferers.
"Our continued investment in the clinical development of Lucentis means that another group of patients who are at risk of losing their eyesight will have the option of a licensed therapy," said David Epstein, division head of Novartis Pharmaceuticals.
Last month, Novartis received European marketing approval for its drug Tasigna to be utilised as a chronic myeloid leukaemia therapy.
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