World Bulletin/News Desk
U.S. drug regulators gave the nod to a wider use for Roche Holding AG's eye drug Lucentis, approving it for diabetic patients with a vision-robbing eye condition.
Lucentis, made by Roche unit Genentech, is already prescribed for two other eye ailments.
The U.S. Food and Drug Administration's approval makes it available for people with diabetic macular edema, or 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. In people affected by DME, damaged blood vessels leak fluid into the retina. This 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. Laser treatment can slow vision loss, but rarely leads to vision improvement.
Insulin, which helps people with diabetes control their blood sugar, is also approved for DME, the FDA said, as better-controlled diabetes reduces the likelihood of vision loss.
In clinical trials, Lucentis helped people see at least 15 extra letters on an eye chart. People were also generally able to sustain the vision improvement 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," said Dr. Renata Albrecht, director of the FDA's ophthalmology products division.
The FDA approved only the 0.3 mg dose of Lucentis, saying a higher dose that was tested showed no extra benefit in vision.
Genentech said it would sell the 0.3 mg dose for $1,170, compared with the $1,950 it charges for the 0.5 mg dose used to treat other eye conditions.
Lucentis is also approved for wet age-related macular degeneration - the leading cause of blindness among the elderly - and for macular edema following retinal vein occlusion (RVO), a swelling or thickening of the part of the retina responsible for central vision.
For macular degeneration, Lucentis has long competed with Regeneron's drug Eylea as well as with Roche's own cancer drug Avastin, which works in a similar manner but for a fraction of the price.
Avastin is not approved for eye disease. But some doctors have cut the cancer treatment into the small doses needed for an eye injection, which costs only about $50.
A U.S. government study last year found the two drugs to be similarly effective for treating macular degeneration.
However, doctors may be more hesitant to use Avastin for patients with diabetes, said Dr. David Brown, a lead investigator for the Lucentis DME trial, and an associate clinical professor at the Methodist Hospital in Houston.
"The sense in the retina community, for whatever reason, is that Avastin doesn't seem to work as well as Lucentis in DME," Brown said.
Roche unit Genentech has also cautioned that Avastin increased the risk of stroke and heart attack in cancer trials, and noted that diabetics are already at much higher risk for serious heart problems.
Alfonso Calvo Rodriguez of Port Isabel, Texas, has had diabetes for about 13 years. He was diagnosed with DME in 2008. Soon, his eyesight made it difficult to drive.
"I would drive with my binoculars next to me, so I could look at the signs or names of streets," he said.
Rodriguez, 57, was forced to have laser surgery to remove blood from his eyes after hemorrhages. His doctor recommended that he enroll in the Lucentis clinical trial at the Methodist Hospital in Houston.
He has been getting monthly injections of the drug for over three years, and said he now needs only glasses to drive.
"I can do just about anything," he said. "I can read. I can work on my computer. I can drive perfectly fine and see the signs on the streets. I'm sure I'd be blind if I didn't have the injections."
The FDA said about 34 percent to 45 percent of those treated with the 0.3 mg dose of Lucentis in clinical trials had vision improvement, compared with 12 percent to 18 percent of those getting no injection.
Common side effects included eye pain, increased pressure inside the eye, and bleeding of the conjunctiva, the tissue that lines the inside of the eyelids and covers the white part of the eye.
Wildlife conservationists have struggled to reverse a decline in numbers of several African species, undermined by ferocious poaching by gangs which mostly ship the ivory to Asia.
Jerald Dennis is feeling stigmatized by his neighbors and has been shunned by his friends
Peru's 2,679 glaciers, spread over 19 snow-capped mountain ranges, are the source of the vast majority of the country's drinking water.
Some 85 percent of people said they thought the disease spread through sneezing or coughing, despite the fact that the World Health Organization regards that type of transmission as unlikely
No approved specific drug or treatment available for battling fatal pandemic virus hitting many West African countries
The death toll so far in the outbreak, first reported in Guinea in March, has reached 4,447 from a total of 8,914 cases, said WHO Assistant Director General Bruce Aylward.
The world's fifth-largest user of nuclear power has around 70 percent, or nearly 9,000 tonnes, of its used fuel stacked in temporary storage pools
The Supreme Council of Health said the infected was a 71-year-old Qatari national who suffered diabetes mellitus, according to the official Qatari news agency
Several airlines have cut flights to the region and there are reports of countries not allowing air ambulances to make refueling stops
A top U.N. official said response to a $1 billion funding appeal had been slow and that a surge in trained healthcare personnel was needed to tackle the crisis
The findings show the pressing need to detect lung cancer before it has shape-shifted into multiple malignant clones.
Second most severe warning issued for extremely heavy smog, air pollution enveloping capital Beijing, Hebei province.
One Ugandan has already died of the virus, which last appeared in the country two years ago killing six people
With already $1 billion invested in alternative sources of production, Sweden plans to produce more using renewable sources.
Each lab would be staffed by a team of three to four experts trained to operate in the worst chemical, biological and nuclear environments
Spanish health officials said four people had been hospitalised to try and stem any further spread of Ebola there after the nurse became the first person in the world known to have contracted the virus outside of Africa.