Novartis approved for Japanese DME patients

Novartis has confirmed a fourth indication for Lucentis (ranibizumab) has received approval from Japanese regulatory bodies.

The drug is used in the treatment of patients with diabetic macular edema (DME), which is one of the leading causes of diabetes-related vision loss and is the first medicine of its kind to significantly improve vision in Asian patients.

In 2013, it generated sales of $2.38 billion (1.42 billion pounds) for Novartis, even though rights are shared with Roche subsidiary Genentech, which co-developed the product.

"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 of Novartis Pharmaceuticals. 

He added the latest approval will mean Japanese DME patients have access to a drug that has unsurpassed efficacy and an exemplary safety profile across multiple indications.

The approval of Lucentis was based on results from the REVEAL Phase III trial.