FDA. US: The U.S. Food and Drug Administration today expanded the approved use
for Lucentis (ranibizumab injection) 0.3 mg to treat diabetic
retinopathy (DR) in patients with diabetic macular edema (DME).
Diabetic
retinopathy is the most common diabetic eye disease and is a leading
cause of blindness in adults in the United States. According to the
Centers for Disease Control and Prevention, diabetes (type 1 and type 2)
affects more than 29 million people in the United States and is the
leading cause of new blindness among people ages 20 to 74 years. In
2008, 33 percent of adults with diabetes aged 40 years or older had some
form of DR. In some cases of DR with DME, abnormal new blood vessels
grow on the surface of the retina. Severe vision loss or blindness can
occur if the new blood vessels break.
Lucentis is administered by a
physician as an injection into the eye once a month. It is intended to
be used along with appropriate interventions to control blood sugar,
blood pressure and cholesterol.
“Diabetes is a serious public
health crisis, affecting more patients every year,” said Edward Cox,
M.D., M.P.H, director of the Office of Antimicrobial Products in the
FDA’s Center for Drug Evaluation and Research. “Today’s approval gives
patients with diabetic retinopathy and diabetic macular edema the first
significant therapy to treat this vision-impairing complication.”
The
drug’s safety and efficacy to treat DR with DME were established in two
clinical studies involving 759 participants who were treated and
followed for three years. In the two studies, participants being
treated with Lucentis showed significant improvement in the severity of
their DR at two years compared to patients who did not receive an
injection.
The most common side effects include bleeding of the
conjunctiva, the tissue that lines the inside of the eyelids and covers
the white part of the eye; eye pain; floaters; and increased pressure
inside the eye (intraocular pressure). Serious side effects include
infection within the eyeball (endophthalmitis) and retinal detachments.
The
FDA granted Lucentis for DR with DME breakthrough therapy designation.
The FDA can designate a drug a breakthrough therapy at the request of
the sponsor if preliminary clinical evidence indicates the drug may
demonstrate a substantial improvement over available therapies for
patients with serious or life-threatening conditions. The FDA also
reviewed the new use for Lucentis under the agency’s priority review
program, which provides for an expedited review of drugs that
demonstrate the potential to be a significant improvement in safety or
effectiveness in the treatment of a serious condition.
The FDA
previously had approved Lucentis to treat DME and macular edema
secondary to retinal vein occlusions, both of which cause fluid to leak
into the macula resulting in blurred vision. Lucentis also is approved
to treat wet (neovascular) age-related macular degeneration (AMD), a
condition in which abnormal blood vessels grow and leak fluid into the
macula.
Lucentis is marketed by South San Francisco, California-based Genentech, a subsidiary of Roche.
The
FDA, an agency within the U.S. Department of Health and Human Services,
promotes and protects the public health by, among other things,
assuring the safety, effectiveness, and security of human and veterinary
drugs, vaccines and other biological products for human use, and
medical devices. The agency also is responsible for the safety and
security of our nation’s food supply, cosmetics, dietary supplements,
products that give off electronic radiation, and for regulating tobacco
products.