A groundbreaking study published in the New England Journal of Medicine shows two drugs -- Avastin and Lucentis -- currently used to treat the "wet" form of macular degeneration work equally well at improving vision in patients with this common eye disease.
This is good news for consumers of health care, particularly Medicare beneficiaries, as the cost of Avastin is typically under $100 a dose whereas Lucentis costs more than $2,000 a dose.
Age-related macular degeneration is the leading cause of blindness in the U.S., affecting more than 2 million Americans age 50 and older. This long-awaited clinical study offers ophthalmologists and patients better treatment options in the management of this, at times, devastating disease.
The study, led by Dr. Dan Martin of the Cleveland Clinic, compared bevacizumab (Avastin) and ranibizumab (Lucentis) in the treatment of neovascular, or "wet," macular degeneration -- in which abnormal blood vessels grow under the macula, the part of the eye responsible for central and reading vision. Both drugs inhibit the growth and leakage of these abnormal vessels. The study treatment protocols were the same for patients receiving either drug. In both groups of patients vision improved in 25 to 34 percent of the treated eyes, and more than 90 percent of affected eyes were protected from further vision loss.
Avastin was originally developed to treat cancer and is FDA-approved for intravenous administration. Based on the knowledge that Avastin inhibited the growth of abnormal blood vessels, ophthalmologists began to inject tiny amounts of the drug into the eye as an "off label" treatment for wet macular degeneration. The results have been extraordinary.
Since then thousands of patients have benefited from Avastin intraocular injections. Lucentis, almost chemically identical to Avastin, was approved by the FDA in 2006 for use in the eye as a treatment for wet AMD.
Even though Avastin is not FDA-approved for macular degeneration it has become the "standard of care" as it is the more frequently used drug.
Both drugs are sold by the same pharmaceutical company, Genentech. Not surprisingly, Genentech has been trying to encourage physicians and patients to choose their FDA-approved drug Lucentis. Most eye MDs have been resistant to this pressure because of the cost.
It is not uncommon for physicians to use a drug "off-label" if the medicine has been shown safe and effective. The results of this study show that Avastin and Lucentis are "equals" in the treatment of macular degeneration.
For reasons yet unknown, some macular degeneration patients may not respond to one drug but get positive results with the other. Ophthalmologists need the flexibility to use either medication when trying to decide what is best for patients.
Eye MDs and their patients have been grateful for the availability of both drugs. In recent years these medications have improved the quality of life for many patients.
Fortunately, local residents who need intraocular injections for the treatment of wet macular degeneration can be treated here in Walla Walla. At Eye and Laser Physicians, for example, we routinely do these treatments in our office.
When receiving these injections for the first time most patients are surprised at how little discomfort they experience. The injections are usually repeated every six weeks for a few months and then the patient is monitored closely. The study also provides clearer guidance on treatment schedules. However, it is still not possible to predict exactly how many injections a particular patient might ultimately need.
The American Academy of Ophthalmology worked closely with Dr. Martin and his team, the National Eye Institute and the Centers for Medicare & Medicaid Services to help lay the foundation for this study and for further research.