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A device that transmits light into the eye can improve the vision of people with a primary form of vision loss known as age-related macular degeneration (AMR). The US Food and Drug Administration (FDA) has decided Monday (November 4).

AMR progressively damages the center of the retina, the light-sensing region at the back of the eye. Recent data suggest that this condition affects about 19.8 million Americans age 40 and over. The disease comes in two forms – dry AMR and wet AMR – the former being more common, compensating about 70% to 90% of cases. However, despite its community, there have been no effective treatments for dry AMR.

Now, the FDA has announced that it will allow a device called the Valeda Light Delivery System to be used as a dry AMR treatment.

“Today’s action brings to market the first therapeutic option for adult patients with dry AMD,” Dr. Malvina Eydelmandirector of the Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices at the FDA’s Center for Devices and Radiological Health, said in the announcement.

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The device, made by LumiThera, contains three light-emitting diodes, better known as LEDs. These diodes emit light of different wavelengthscorresponding to the yellow, red and near-infrared portions of the electromagnetic spectrum. There is evidence to suggest that these wavelengths have an effect on the retina’s mitochondria, the powerhouses of its cells.

Mitochondria malfunction in dry AMR, and previous research has suggested that this type of light exposure can enhance the plants’ ability to make fuel and repair damage. At the same time, it can cause mitochondria to release chemicals that boost blood flow to the retina while reducing inflammation, according to The Macular Societya UK charity.

The LED device has been tested in a clinical trial involving 100 people with early or intermediate stage dry AMR. Of these subjects, 91 eyes were treated with the Valeda Light Delivery System and 54 received sham treatment. Participants received either this treatment or a placebo three times a week for three to five weeks, and then this pattern was repeated every four months for two years.

On average, the treated eyes could see at least five more letters on the eye chart than they had before treatment, roughly equivalent to a full line on the chart. These improvements were seen halfway through the study and again at the end of the study, so the improvement appears to last at least that long.

Additionally, compared to untreated eyes, a smaller percentage of treated eyes progressed to the most advanced stage of RAM—by only about 7% get worse compared to 24% of the placebo group.

Normally, as AMR progresses, clumps of protein and fat called drusen form under the retina. Increasing or more abundant drusen is considered a hallmark of AMR because it coincides with retinal cell degradation. In the treated eyes, any lumps that were present did not appear to increase in size, while they grew larger in the untreated eyes.

Based on this data, the FDA has cleared the Valeda Light Delivery System to be marketed as a way to help improve vision in certain patients with dry AMD.

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“The results supported the overall safety benefits of treating dry AMD earlier,” Dr. Glenn Jaffe from Duke University School of Medicine, which was involved in the trial, said in a statement from LumiThera. In other words, the device can help most in the early stages of dry AMR, before permanent vision loss occurs.

This article is for informational purposes only and is not intended to provide medical advice.

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