Novartis' Lucentis first drug approved in EU for myopic choroidal neovascularization

The European Commission has granted Swiss drug major Novartis (NOVN: VX) a new indication for Lucentis (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV). This follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) earlier this year (The Pharma Letter May 31).

This makes Lucentis, specifically designed for the eye and proven to save sight, the first anti-VEGF therapy licensed for four indications in the European Union, the company noted. Analysts at Credit Suisse put an ex-USA (where Roche sells the drug) net present value for Lucentis across all indications of 5.02 Swiss francs (6% of total) for Novartis. Lucentis generated first-quarter 2013 sales of $596 million.

Pathologic myopia often affects working-age adults and is a major cause of vision loss worldwide, with 1%-3% of the general population. CNV is the most common vision-threatening complication of high myopia. In patients with untreated myopic CNV the long-term prognosis is poor with around 90% of affected patients developing severe vision loss after five years. The resulting visual loss from myopic CNV which usually affects people younger than 50 years old has a profound effect on productivity, financial status, career expectations, and quality of life in working-age individuals.