U.S. drugs regulators gave the nod to a wider use for Roche Holding AG's eye drug Lucentis, for diabetic patients with a vision-robbing eye condition.
Lucentis is already sold for two other eye ailments, but the U.S. Food and Drug Administration's approval makes it available for people with diabetic macular edema (DME), the most common cause of blindness in people of working age.
The once-monthly injection is now the only FDA-approved drug specifically targeted at DME. But a highly promising candidate from Regeneron Pharmaceuticals Inc may be not too far behind.
DME is a swelling of the retina that occurs in diabetics who suffer from retinopathy, the most common eye disease for people with diabetes that involves damaged blood vessels leaking fluid into the retina. It causes blurred vision and severe vision loss.
In 2010, about 3.9 million adults diagnosed with diabetes reported trouble with their vision, the FDA said.
DME has long been treated by laser, which stops blood vessel leakage and can slow vision loss but rarely leads to vision improvement. The FDA said insulin, which helps people with diabetes control their blood sugar, is also approved for DME as better-controlled diabetes reduces the likelihood of vision loss.
In clinical trials, Lucentis, made by Roche unit Genentech, helped people see at least 15 extra letters on an eye chart. People were also generally able to sustain the improvement in vision for at least 24 months, but they have to continue taking the drug to maintain the benefits.
"Today's approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease," said Dr. Renata Albrecht, director of the FDA's ophthalmology products division.
The FDA approved only the 0.3 mg dose of Lucentis, though a higher dose was also tested. The FDA said the 0.5 mg dose showed no extra benefit in vision.
(Reporting by Anna Yukhananov; Editing by Leslie Gevirtz and John Wallace)
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