New studies show that a drug approved this summer to treat age-related macular degeneration not only prevents vision loss but improves the sight of patients who suffer from this eye discorder, which occurs when the macula, or central portion of the retina, breaks down and hinders the ability to decipher fine details.
"This is a remarkable step forward," said Dr. Frederick Ferris, clinical director of the National Eye Institute at the National Institutes of Health.
The studies were published today in the New England Journal of Medicine.
Age-related macular degeneration, or AMD, is the No. 1 cause of vision loss and legal blindness in adults. One in three people will be touched by it by the time they reach age 75, and experts expect a virtual AMD epidemic as the population ages.
The disease gradually destroys a person's sharp central vision so that daily activities, such as driving and reading, become impossible. Recognizing faces also becomes difficult. But treatment is available for some.
The FDA approved a drug to treat the more advanced form of AMD, known as wet AMD, last June. Between 10 and 15 percent of AMD patients have this form.
Researchers gave monthly injections of the drug ranibizumab, or Lucentis, to nearly 500 patients with AMD and gave sham injections to about 200 more patients.
After two years, nearly 95 percent of the patients who received Lucentis saw more clearly than they did when the study began. The researchers measured visual acuity by asking patients to read letters off a doctor's eye chart.
The Lucentis patients could read more letters off the chart after they took the drug. Doctors said the finding is something to celebrate.
"Patients have done incredible with this drug. It is like nothing we have ever seen before," said Dr. Peter Kaiser at the Cole Eye Institute at Ohio's Cleveland Clinic.
Kaiser is the author of the studies published today and has been an investigator in all the Lucentis trials.
But the patients who did not take Lucentis saw the letters on the eye chart less clearly after two years. Their vision actually got worse over the course of the study.
The study authors concluded that Lucentis not only prevents vision loss but makes vision better.
Before Lucentis became available, some doctors treated wet AMD with the cancer drug bevacizumab, sold as Avastin.
Some still prescribe Avastin for AMD, even though that use is considered "off-label" because the FDA has not approved Avastin to treat AMD.
Without the FDA approval for AMD, most insurers won't pay for it to treat that disorder.
"FDA approval is required for most insurance companies to cover the cost," said Dr. Richard Bensinger, spokesman for the American Academy of Ophthalmology.
"Therefore Avastin is not covered by most plans."
Doctors said Lucentis really works, and since it has an FDA stamp of approval, most health plans will cover it. But Lucentis is significantly more expensive than Avastin.
"Companies will pay $1,500-$2,000 for the Lucentis rather than the $40-$80 for Avastin," said Bensinger.
"This means that if the patient is insured, the insurance coverage will be for the larger bill. If the patient is uninsured, Avastin is likely to be used."
The extra cost of Lucentis isn't something to sneeze at.