FDA approves drug to treat diabetic macular edema

August 13, 2012

The U.S. Food and Drug Administration today announced its approval of Lucentis (ranibizumab injection) for the treatment of diabetic macular edema, or DME, an eye condition in people with diabetes that causes blurred vision, severe vision loss and sometimes blindness. A retinal specialist at The Methodist Hospital in Houston, Texas, was one of the lead investigators in the research that led to today’s FDA approval.

The drug 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 usual resort in the United States has been laser surgery, which slows the rate of vision loss and helps stabilize vision, but has demonstrated only limited ability to restore lost vision.

“This approval is an important advancement in the fight against blindness for people with ,” said David M. Brown M.D., retinal surgeon at Methodist. “Now that it will be available, Lucentis therapy can begin to make a difference in the lives of our patients with DME.”

Diabetes is 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.

The FDA first approved Lucentis for treatment of wet age-related macular degeneration in 2006 and for macular edema following retinal vein occlusion in 2010. Brown and his research team were integrally involved in the research that led to these FDA approvals as well.

The approval of Lucentis in DME was based on manufacturer Genentech’s Phase III trials, RIDE and RISE, two identically-designed, parallel, double-masked, three-year clinical trials, which were sham-treatment controlled for 24 months. A total of 759 patients were randomized into three groups to receive monthly treatment with 0.3 mg Lucentis (n=250), 0.5 mg Lucentis (n=252) or sham injection (control group, n = 257). In the studies, treatment with Lucentis demonstrated improved clinical outcomes including substantial visual gain for many DME patients. Results showed patients who received 0.3 mg Lucentis experienced significant, early (Day 7) and sustained (24 months) improvements in vision.

More patients who received Lucentis were able to read at least three additional lines (15 letters) on the at 24 months; had average vision gains exceeding two lines (10 letters) on the eye chart at 24 months; and were significantly more likely to maintain their vision (lose < 15 letters on the eye chart) at 24 months.

DME is swelling of the macula, the central part of the retina responsible for sharp, central vision. DME begins with diabetes, which can cause damage to in the eye over time. When this happens, a patient is said to have diabetic retinopathy, the most common diabetic eye disease. The damaged blood vessels can leak blood and fluid, causing swelling and blurred , severe and sometimes blindness.

Nearly 26 million Americans have diabetes, which has become the leading cause of new cases of in adults aged 20-74. Among Americans aged 40 years and older, more than 4.2 million have diabetic retinopathy.

Lucentis is a prescription medicine for the treatment of patients with wet AMD, macular edema following RVO and DME. Lucentis is a recombinant humanized monoclonal antibody fragment (lacking an Fc region). Lucentis is the first VEGF inhibitor specifically designed for use in the eye to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.

Explore further: Avastin and Lucentis are equivalent in treating age-related macular degeneration

Related Stories

Avastin and Lucentis are equivalent in treating age-related macular degeneration

April 30, 2012
At two years, Avastin (bevacizumab) and Lucentis (ranibizumab injection), two widely used drugs to treat age-related macular degeneration (AMD), improve vision when administered monthly or on an as needed basis, although ...

Study finds Avastin and Lucentis are equally effective in treating AMD

April 28, 2011
Researchers are reporting results from the first year of a two-year clinical trial that Avastin, a drug approved to treat some cancers and that is commonly used off-label to treat age-related macular degeneration (AMD), is ...

Recommended for you

Drug for spinal muscular atrophy prompts ethical dilemmas, bioethicists say

December 11, 2017
When the Food and Drug Administration approved the first drug for people with spinal muscular atrophy a year ago, clinicians finally had hope for improving the lives of patients with the rare debilitating muscular disease. ...

FDA's program to speed up drug approval shaved nearly a year off the process

December 7, 2017
Speeding the pace at which potentially lifesaving drugs are brought to market was a rallying cry for Donald Trump as a candidate, and is a stated priority of his Food and Drug Administration commissioner, Dr. Scott Gottlieb. ...

Dangers of commonly prescribed painkillers highlighted in study

December 6, 2017
Commonly prescribed painkillers need to be given for shorter periods of time to reduce the risk of obesity and sleep deprivation, a new study has revealed.

Viagra goes generic: Pfizer to launch own little white pill

December 6, 2017
The little blue pill that's helped millions of men in the bedroom is turning white. Drugmaker Pfizer is launching its own cheaper generic version of Viagra rather than lose most sales when the impotence pill gets its first ...

Surgery-related opioid doses can drop dramatically without affecting patients' pain

December 6, 2017
Some surgeons might be able to prescribe a third of opioid painkiller pills that they currently give patients, and not affect their level of post-surgery pain control, a new study suggests.

Four-fold jump in deaths in opioid-driven hospitalizations

December 4, 2017
People who end up in the hospital due to an opioid-related condition are four times more likely to die now than they were in 2000, according to research led by Harvard Medical School and published in the December issue of ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.