FDA Approves First Implantable Miniature Telescope to Improve Sight of AMD patients

The U.S. Food and Drug Administration  announced July 6 it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage age-related macular degeneration (AMD).

Surgically implanted in one eye, the IMT is a small telescope that replaces the natural lens and provides an image that has been magnified more than two times.

AMD, a condition that mainly affects older people, damages the center of the retina (macula) and results in a loss of vision in the center of the visual field. About 8 million people in the United States have AMD and nearly 2 million of them already have significant vision loss, according to the National Eye Institute. AMD can make it difficult or impossible to recognize faces or perform daily tasks such as reading or watching television.

"This innovation has the potential to provide many people with an improved quality of life," said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The IMT is available in two models: one that provides 2.2 times magnification and another 2.7 times magnification. The IMT is designed to magnify and project images onto a healthy portion of the retina. The IMT is intended to be implanted in only one eye; the non-implanted eye is used for peripheral vision.

The IMT is used in patients ages 75 years and older with stable severe to profound vision impairment (when vision impairment has not changed over time) caused by blind spots (bilateral central scotoma) associated with end-stage AMD. These patients also have evidence of a visually significant cataract.

Patients agree to undergo training with an external telescope with a low vision specialist prior to implantation to determine whether adequate improvement in vision with the external telescope can be obtained and to verify if the patient has adequate peripheral vision in the eye that would not be implanted. Patients also agree to participate in a post-operative visual training program.

In a 219-patient, multi-center clinical study of the IMT, 90 percent of patients achieved at least a 2-line gain in either their distance or best-corrected visual acuity, and 75 percent of patients improved their level of vision from severe or profound impairment to moderate impairment.

Because the IMT is a large device, implantation can lead to extensive loss of corneal endothelial cells (ECD), the layer of cells essential for maintaining the clarity of the cornea, and chronic endothelial cell loss. The chronic rate of endothelial cell loss is about 5 percent per year. Significant losses in ECD may lead to corneal edema, corneal decompensation, and the need for corneal transplant. In the study, 10 eyes had unresolved corneal edema, with five resulting in corneal transplants. The calculated five-year risk for unresolved corneal edema, corneal decompensation, and corneal transplant are 9.2 percent, 6.8 percent and 4.1 percent, respectively.

To ensure that the risks of IMT implantation are sufficiently and consistently communicated to patients, the FDA and the manufacturer created detailed labeling, including an Acceptance of Risk and Informed Decision Agreement, which patients must complete prior to IMT implantation. The agreement provides a guide for patients and their physicians to discuss the risks associated with IMT implantation. Patients should be given adequate time to review all of the information regarding the IMT.

As a condition of FDA approval, the manufacturer, VisionCare Ophthalmic Technologies Inc. of Saratoga, Calif., must conduct two post-approval studies. In one study, VisionCare must continue follow-up on the subjects from its long-term follow-up cohort for an additional two years. Another study of 770 newly enrolled subjects will include an evaluation of the endothelial cell density and related adverse events for five years after implantation.

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Harvard Study Shows Folic Acid, B Vitamins in Animi-3(R) May Prevent Vision Loss

/PRNewswire/ -- A new study by researchers at Harvard Medical School has found that combining essential B vitamins, including B6, B12, and folic acid, lower risk of developing age-related macular degeneration (AMD), one of the leading causes of vision loss among older Americans. These ingredients, which are formulated in combination with key omega-3 fatty acids and phytosterols, are also contained in the prescription supplement Animi-3, which is actively being prescribed by physicians to address deficiencies in these nutrients.

In the randomized, double-blind clinical trial, more than 5,000 women with heart disease, and at least three risk factors for cardiovascular disease, were given vitamins B6, B12, and folic acid over a seven-year time period. At the end of the trial, approximately 34 percent of the women had a lower risk of developing any type of AMD, while 41 percent had a lower risk of more severe forms of AMD.

"What's interesting here is the study authors note the correlation between age-related macular degeneration and cardiovascular disease," said nutritional expert Dr. Barbara Levine, Weill Cornell Medical College. "I recommend patients with nutritional deficiencies speak to their physicians about Animi-3, which is formulated with these essential B vitamins and DHA, the most important omega-3 fat, to address various conditions, including heart disease, arthritis, eye health, and depression."

"DHA is highly concentrated in the retina of the eye, which is one of the reasons why a DHA deficiency may be important to vision," added President Jack Schramm, PBM Pharmaceuticals, Inc., the makers of Animi-3. "Animi-3 delivers DHA as well as B6, B12, and folic acid. Studies continue to suggest that DHA, along with a combination of vitamins B6, B12, and folic acid, can address deficiencies in these nutrients associated with eye problems, including dry eye and macular health."

Each capsule of Animi-3 contains 500 mg of omega-3, (350 mg of DHA), 200 mg of phytosterols, 1 mg of folic acid, 12.5 mg of B6, and 12 mcg of B12.

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