January 7, 2011 / 6:59 AM / 9 years ago

UPDATE 1-Novartis sight drug gets broader EU approval

* Drug show to approve vision in DME patients * EC approval in line with EMA recommendation ZURICH, Jan 7 (Reuters) - Swiss drugmaker Novartis AG NOVN.VX said on Friday the European Commission has approved broader application of its Lucentis drug to treat visually impaired patients, giving sales of the drug a potential boost.

The EU approved the drug for the treatment of patients with visual impairment caused by diabetic macular edema (DME), a major cause of blindness in working-age populations in most developed countries.

“Lucentis is the first licensed therapy to significantly improve both vision and vision-related quality of life in patients with visual impairment due to DME,” Novartis said in a statement.

The approval of Lucentis was based on data from two Novartis-sponsored clinical trials which showed Lucentis provided more rapid and sustained visual acuity gain versus sham (dummy) therapy or laser therapy, the current standard of care.

The EU approval is in line with a recommendation from the European Medicines Agency last October.

Novartis, the maker of high blood pressure drug Diovan, said Lucentis is currently used to treat wet age-related macular degeneration in more than 85 countries. (Editing by Mike Nesbit)

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