Novartis's Visudyne use extended in EU

Novartis Ophthalmics has been granted approval in the European Union tomarket Visudyne (verteporfin) for a new indication, the treatment of subfoveal choroidal neovascularization secondary to pathologic myopia, a severe eye disorder that can result in a progressive loss of vision. Visudyne is already approved in the EU for CNV caused by age-related macular degeneration.

Analysts at Swiss broker Sarasin note that EU approval for the new indication has come earlier than anticipated and will give an added boost to this product, which is marketed via a 50:50 joint venture with QLT. The new indication affects around 50,000 patients a year worldwide, and will help push the product towards its peak sales potential of 1 billion Swiss francs ($586 million) a year, they note.

Moreover, the expanded use cements Visudyne's position in the market in advance of competing products, notably Pharmacia's tin ethyl etiopurpurin, which is scheduled for launch in the second half of 2002. In the USA, Novartis and QLT have received an approvable letter from the Food and Drug Administration for CNV secondary to pathological myopia, and have submitted additional information on the drug to answer outstanding questions at the agency.