Swiss pharma giant Roche said Monday it will sell in the United States a drug that treats a diabetes-related illness linked to blindness after getting the regulatory green light.
The US Food and Drug Administration's (FDA) decision means that Roche can take Lucentis to the US to treat diabetic macular oedema (DME), a condition that causes swelling, blurred vision and blindness in people with diabetes.
In a statement Roche called the development the "first major treatment advance in more than 25 years for (the) sight-threatening condition."
"For the first time, Americans with diabetic macular oedema will have access to an FDA-approved medicine shown to help many patients rapidly regain substantial amounts of lost vision," said Hal Barron, global product development director at Roche.
Lucentis is described by Roche as the "first and only FDA-approved medicine" to help those with the condition, which is otherwise treated with limited success by laser surgery.
Nearly 26 million Americans have diabetes which is the principal cause of blindness in America, Roche said in a statement.
More than 560,000 have related macular oedema and one in 10 people with diabetes will get DME during their lifetime, the Basel-based manufacturer added.
According to Swiss market analysts Helvea, sales of Lucentis could reach $1.6 billion (1.3 billion euros).
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