Paul Sternberg, M.D., implants a new timed-release drug delivery system into patient Darius Doyle's eye during surgery Monday. Doyle suffers from uveitis, a chronic inflammatory disease of the eye.
Photo by Dana Johnson
New implant helps ease chronic eye inflammation
Vanderbilt University Medical Center is the first in the region to implant a device called Retisert, a drug-delivery method that will treat a chronic inflammatory disease of the eye called uveitis.
Retisert is the first FDA-approved implant for this condition that affects nearly 180,000 people nationwide. Posterior uveitis refers to the inflammation of the uvea, which is in the back portion of the eye. Uveitis primarily affects people between the ages of 20 and 50 and is one of the leading causes of blindness in the nation.
Steroid treatment is the traditional therapy. Patients use either eye drops, injections into the infected site or oral treatment or a combination of the various therapies. In cases where steroids have not been effective, Methotrexate, an anticancer drug, is used.
“There is a limited number of patients for whom this new treatment will be applicable,” said Paul Sternberg, M.D., director of the Vanderbilt Eye Institute. “For those patients whose condition could not previously be controlled with standard therapy, this new implant will provide an option for them. This is a therapy that will have a liberating effect on their quality of life.”
U.S. Army Sgt. Darius Doyle, 35, the first patient in the region to undergo the procedure, hopes the implant will put an end to his excruciating routine of hourly eye drops and eye injections.
“I've had this condition since 1993,” Doyle said. “I first used steroid drops a few times a day, but now I'm using them every hour or more. Over the course of having this condition I grew tired of the regimen. I was burned out and just quit using any therapies.
“It's hard to keep it going because it interferes with every aspect of your life. I became really discouraged.”
But pressure from family and friends to restart the therapies also led him to Sternberg in March.
“Right now, I am totally in support of anything that can improve my vision,” Doyle said. “I definitely can't see it getting any worse by having this procedure done. I have already lost so much freedom because of it.”
Retisert is capable of releasing a set dose of steroids over a 30-month period. The miniscule device, created by Bausch and Lomb, will be implanted behind the eye and is not detectable by the patient.
A study of the device showed a significant decrease in the recurrence of uveitis from 40 percent to 54 percent pre-implant over a 34-week period to 7 percent to 14 percent post-implant for the same duration.
The use of additional therapies decreased from about 47 percent to 63 percent at time of implantation to about 5 percent to 10 percent at three weeks post implantation. The improvement in visual acuity also improved in 19 percent to 21 percent of patients at 34 weeks post implantation.
The implant, 3 mm by 2 mm by 5 mm, contains .59 milligrams of steroid.
Sternberg said the prototype of the device, the vitrasert, was first created in the 1990s to treat patients with viral retinitis, a common AIDS-related eye disorder. With the introduction of a cocktail drug called HAART, the retinitis was frequently controlled and the implant was only rarely needed.
“But the scientists who created the vitrasert technology began looking at other drugs that could benefit from a sustained-release delivery system into the eye,” said Sternberg. “Because of the wide use of the vitrasert, experienced retinal surgeons can implant this new device.”
Although there are side effects of the implant, including the possible development of cataracts and glaucoma, both have surgical treatments.
The biggest cause for concern comes from the cost of the device. At $18,000, many insurance companies will question the need.
“This is a big ticket item for insurance providers and it will be challenging to get insurance companies to cover it,” Sternberg said. “We try to demonstrate the money saved by not being on the eye drops and other medications.
“The quality of life issue is a big piece that we convey to providers. There is no price on that. We also hope to see this new technology make a huge difference in about 90 percent of patients with uncontrolled uveitis.”
Sternberg said improvements should be noticeable within three weeks following surgery.
“With the creation of this sustained release therapy, we hope to see similar devices for disorders like glaucoma and macular degeneration.”
Sternberg is George W. Hale Professor and Chair of Ophthalmology and Visual Sciences.