Thanks to the drug, Parnes says he's been able to tell several patients that there's a good chance their vision will improve. Other treatments are available, but they stabilize vision or slow the degeneration, although many patients continue to lose vision.
"It's the first time I can say to people, 'I may be able to help you and make you see better'," Parnes says.
"It's a breakthrough therapy," says Dr. George A. Williams, a retinal surgeon ophthalmologist and chairman of the Department of Ophthalmology at William Beaumont Hospital in Royal Oak, Mich. "It's the first therapy that we've had in which we expect patients to have visual improvement and it's clearly the best-available therapy."
A cause of blindness
Macular degeneration is the most common form of legal blindness in the U.S. Caucasian population, says Parnes, an ophthalmologist and vitreo-retina specialist in Hagerstown.
Lucentis helps patients who have recently been diagnosed with wet macular degeneration, which occurs when abnormal blood vessels grow in the center of the retina and break or bleed, causing a rapid loss of central vision. Researchers aren't sure what causes the abnormal blood vessel growth. It might be the body's attempt to repair damage from dry macular degeneration, Parnes says. People with wet macular degeneration first have the dry variety, though not everyone with the dry variety develops the wet type, Parnes says.
The key to improving damaged vision is catching wet macular degeneration early, Williams says. Wait too long and scarring can occur. At that point, Parnes says, Lucentis can't help.
Other treatments
Originally, wet macular degeneration was treated with a laser used to destroy abnormal blood vessels, but sometimes damage caused by the laser made vision worse, Parnes says.
Then in 2000 a photodynamic therapy was approved by the FDA that involved injecting Visudyne into the arm. A cold laser light directed into the eye activates the drug, causing the blood vessels to shrink over time. However, improved vision occurred in fewer than 10 percent of patients, experts say.
Only 15 percent of patients with wet macular degeneration were candidates for the treatment, Parnes says. The majority of patients treated with photodynamic therapy continued to slowly lose vision.
In December 2004, the FDA approved Macugen (generic name: pegaptanib), made by Eyetech Pharmaceuticals, which helped 6 percent to 10 percent of patients achieve significant vision improvement, experts say.
The drug has a long track record of being well tolerated by patients and, like photodynamic therapy, is still used, experts say.
While Lucentis was still in clinical trials, showing promise, Dr. Phil Rosenfeld in Miami got the idea to treat wet macular degeneration patients with Avastin (generic name: bevacizumab), Parnes and Williams say. Avastin had been approved for colon cancer patients, but not for macular degeneration. The drug restricts the blood supply to tumors; for wet macular degeneration, Rosenfeld found that the drug could reduce blood vessel growth in people and leakage from the vessels.
Doctors can use a product for an off-label use to treat a patient, but the manufacturer cannot advertise a drug to be used that way, FDA spokeswoman Megan Moynahan says.
A new tool
When Lucentis was approved, it gave new hope to people diagnosed with wet macular degeneration within the last six to 12 months. Here was an FDA-approved option that, according to two studies, gave recently diagnosed patients a 33 percent to 40 percent chance of improved vision, Parnes says. That could mean three lines of improvement on the eye chart.
For people diagnosed within the past year, there was hope the medicine could prevent further vision loss.
Parnes says 95 percent of patients treated monthly for a year with Lucentis maintained their vision for more than one year, compared to 60 percent in the control group who received a placebo injection.
Like Macugen and Avastin, Lucentis is injected into the eye, Parnes says.
Help with costs
Some doctors still offer Avastin to patients because of the cost difference, Parnes says. Avastin costs about $50 or less a dose, whereas Lucentis costs about $2,000 a dose. Both drugs are made by Genentech, from whom Parnes says he has received no funding.
