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.
Researchers said the findings challenge the universal endorsement of paracetamol as the first choice painkiller for lower back pain.
The 39-year-old Sheik Umar Khan, hailed as a "national hero" by the health ministry, was leading the fight to control an outbreak that has killed 206 people in the West African country
Shanghai food watchdog said it sealed more than 1,000 tonnes of suspected meat products from OSI in China, and a further 100 tonnes of products from a range of its customers.
Children in Syria are at greatest risk as routine immunisation has been disrupted and many health centres are severely damaged after more than three years of conflict
151 people who came into direct contact with the victim were also placed in quarantine.
Viruses that spread through air - such as flu viruses for example - are far more likely to spread swiftly and widely in human populations
TV report that showed workers picking up meat from a factory floor, as well as mixing meat beyond its expiration date with fresh meat
Religious leaders to preach in their churches and mosques for a change of attitude towards the disease
The three people in the latest reported cases had "mild symptoms" and have fully recovered after being treated with antibiotics, the department said, adding that they are no longer contagious.
A state landmark, Mount Rainier last erupted in the 19th century. It is widely expected to erupt again, according to the U.S. National Park Service.
The new vaccine will help save the lives of hundreds of thousands of South Sudanese children.
Food security became a hot topic after record high grain prices in 2008 marked the start of a period of volatility.
An agreement by the court with the advocate general's opinion would have significant repercussions on employers as they could be required to make special adjustments for morbidly obese employees
Steroid-containing inhalers' potential effect on children's growth is a source of worry for parents and doctors
The hole was found near the Bovanentsky gas field, leading to speculation that it could have been caused by an underground explosion.
A team at McGill University developed a pill that cures a form of blindness that usually affects newborns.