Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that Lucentis® (ranibizumab injection) was
approved by the U.S. Food & Drug Administration (FDA) for treatment of
diabetic macular edema (DME), an eye condition in people with diabetes
that causes blurred vision, severe vision loss and sometimes blindness.
Diabetes is now the leading cause of new cases of blindness in American
adults and DME is estimated to affect more than 560,000
Americans with the disease.
Lucentis is the first and only FDA-approved medicine for DME, a
condition for which the standard of care has not changed significantly
in more than 25 years. To date, the standard of care in the U.S. for DME
has been laser surgery, which slows the rate of vision loss and helps
stabilize vision, but has demonstrated only limited ability to restore
"For the first time, Americans with diabetic macular edema will have
access to an FDA-approved medicine shown to help many patients rapidly
regain substantial amounts of lost vision," said Hal Barron, M.D., chief
medical officer and head, Global Product Development. "We developed
Lucentis to treat diseases of the eye and are pleased to have received
this third U.S. indication to help a new population of people whose
eyesight may be affected by diabetes."
"This approval is an important advancement in the fight against
blindness for people with diabetes," said David M. Brown M.D., Retinal
Specialist at The Methodist Hospital, Houston Texas, and clinical trial
investigator. "Now that it will be available, Lucentis therapy can begin
to make a difference in the lives of our patients with DME."
Lucentis 0.5 mg once monthly was first approved by the FDA for treatment
of wet age-related macular degeneration (AMD) in 2006 and for macular
edema following retinal vein occlusion (RVO) in 2010. Lucentis 0.3 mg
once monthly was approved for DME, and physicians can order immediately
with shipments expected to begin August 15.