Novartis gets fourth indication, DME, for Lucentis in Japan

Swiss drug major Novartis (NOVN: VX) says it has received approval from Japanese regulatory bodies for a fourth indication for Lucentis (ranibizumab): the treatment of patients with diabetic macular edema (DME), a leading cause of vision loss among patients with diabetes.

Laser therapy, the current standard of care in Japan, has provided stabilization of vision in many patients, but generally does not improve vision. Lucentis is the first licensed therapy to significantly improve vision in Asian patients with visual impairment due to DME. The drug generated full-year 2013 sales of $2.38 billion for Novartis, which has rights to market Lucentis outside the USA, where these are vested with Roche subsidiary Genentech, which co-developed the product with Novartis.

"Lucentis has previously been shown to be an effective treatment, improving vision loss and vision-related quality of life for patients with DME," said Tim Wright, global head of development, Novartis Pharmaceuticals. "Now Japanese patients living with DME have access to Lucentis, a drug with an unsurpassed efficacy and safety profile across multiple indications," he noted.