FDA approves drug to treat diabetic macular edema
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 todays 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 diabetes, 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 Genentechs 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 eye chart 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 blood vessels 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 vision, severe vision loss and sometimes blindness.
Nearly 26 million Americans have diabetes, which has become the leading cause of new cases of blindness 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.
Provided by The Methodist Hospital System
- Researchers find no difference in drugs for macular degeneration Oct 01, 2010 | not rated yet | 0
- FDA panel unanimously backs Regeneron eye drug Jun 17, 2011 | not rated yet | 0
- Cheaper eye drug proves as good as pricier one Apr 28, 2011 | not rated yet | 0
- Comparative-effectiveness study confirms new treatment for diabetic macular edema Apr 27, 2010 | not rated yet | 0
- Avastin and Lucentis are equivalent in treating age-related macular degeneration Apr 30, 2012 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
Pressure-volume curve: Elastic Recoil Pressure don't make sense
May 18, 2013 From pressure-volume curve of the lung and chest wall (attached photo), I don't understand why would the elastic recoil pressure of the lung is...
If you became brain-dead, would you want them to pull the plug?
May 17, 2013 I'd want the rest of me to stay alive. Sure it's a lousy way to live but it beats being all-the-way dead. Maybe if I make it 20 years they'll...
MRI bill question
May 15, 2013 Dear PFers, The hospital gave us a $12k bill for one MRI (head with contrast). The people I talked to at the hospital tell me that they do not...
Ratio of Hydrogen of Oxygen in Dessicated Animal Protein
May 13, 2013 As an experiment, for the past few months I've been consuming at least one portion of Jell-O or unflavored Knox gelatin per day. I'm 64, in very...
Alcohol and acetaminophen
May 13, 2013 Edit: sorry for the typo in the title , can't edit I looked around on google quite a bit and it's very hard to find precise information on the...
Marie Curie's leukemia
May 13, 2013 Does anyone know what might be the cause of Marie Curie's cancer
- More from Physics Forums - Medical Sciences
More news stories
Europe's medicines watchdog said Friday the benefits of acne drug Diane-35, also widely used as a contraceptive, outweigh the risk of developing blood clots in the veins—when correctly prescribed.
Medications May 17, 2013 | not rated yet | 0
Singapore's Agency for Science, Technology and Research (A*STAR) and Switzerland's Cytos Biotechnology AG today announced that the first healthy volunteer has been dosed in a Phase 1 clinical trial with their ...
Medications May 17, 2013 | 5 / 5 (1) | 0
(Medical Xpress)—An aspirin a day may not always keep heart disease away, say two University of Florida cardiologists. But a new algorithm they have developed outlines factors physicians should weigh as ...
Medications May 16, 2013 | 3.5 / 5 (2) | 0 |
(HealthDay)—The U.S. Food and Drug Administration has approved new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) in an effort to cut down on daytime drowsiness that could be a hazard ...
Medications May 15, 2013 | not rated yet | 0
Researchers at the University of Wisconsin have identified a potential new risk factor for obstructive sleep apnea: asthma. Using data from the National Institutes of Health (Heart, Lung, and Blood Institute)-funded Wisconsin ...
3 hours ago | not rated yet | 0 |
A new study looking at sleep-disordered breathing (SDB) and markers for Alzheimer's disease (AD) risk in cerebrospinal fluid (CSF) and neuroimaging adds to the growing body of research linking the two.
4 hours ago | not rated yet | 0 |
The hunt for an HIV vaccine has gobbled up $8 billion in the past decade, and the failure of the most recent efficacy trial has delivered yet another setback to 26 years of efforts.
8 hours ago | not rated yet | 0
In their quest to learn more about the variability of cells between and within tissues, biomedical scientists have devised tools capable of simultaneously measuring dozens of characteristics of individual ...
4 hours ago | 5 / 5 (1) | 0 |
Scientists at Johns Hopkins have turned their view of osteoarthritis (OA) inside out. Literally. Instead of seeing the painful degenerative disease as a problem primarily of the cartilage that cushions joints, ...
4 hours ago | 5 / 5 (1) | 0 |
The devastating effect of Alzheimer's disease on bilingual people has been thrown into focus in Canada, where the sudden loss of a second language can leave sufferers feeling like strangers in their own country.
6 hours ago | not rated yet | 0