A Brighter Horizon for Dry Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is an eye disease that leads to vision loss and can cause blindness. The dry form affects 80% of individuals with AMD.

It tends to progress more slowly than the wet type but leads to a subsequent loss of visual acuity. In dry AMD, drusen can form below the macula over time, causing a progressive loss of central vision.

Until recently, apart from nutritional advice, there was no suitable intervention before the patient developed the wet form of AMD.

Several studies have recently shown encouraging results treating eye disease, such as AMD with a technique known as photobiomodulation (PBM).

The process is not a heat therapy but is more akin to photosynthesis in plants or 'Physiotherapy for the eye'.

Light, in the far red and near-infrared spectral range, can stimulate the cells, which lead to a cascade of photochemical reactions. This may facilitate the repair of damaged tissue in the retina and promote function.

The original study (LightSite 1) was undertaken in Canada with patients given 9 treatments over a 3 to 4 week period. The patients were tested before treatment and the 1 month after treatment and the majority had intermediate to advanced AMD.

Results, 50% of PBM treated patients showed an improvement of 5 or more letters, with 92% of patients with no Geographical Atrophy at the start responding. At the same time contrast sensitivity improved and in a group of patients, drusen volumes were seen to fall.

A second study (LightSite 2) was set up in Europe, with the UK, France, Germany, Italy, and Spain taking part using a similar regime of 9 treatments in 3 to 4 weeks. While interrupted by Covid which reduced the recruitment of patients, the interim results have been similarly striking.

These patients were at an earlier stage in the disease and had better vision to begin with however 35% of PBM treated patients had 5 or more letters of improvement. At the same time the growth rate of Geographical Atrophy was decreased by 44% at 10 months.

Another study from America (The ElectroLight Study) assessed the patients for visual acuity, contrast sensitivity and Electroretinography (ERG) of the visual function.

Interim analysis showed a 47.8% improvement in Acuity of 10 to 14 letters and an improvement in contrast sensitivity. At the same time the patients showed an improvement in function over time with the ERG parameters.

The Valeda Light Delivery System is the first approved treatment for Dry Age-Related Macular Degeneration (Dry AMD) using Photobiomodulation. Dry AMD is the leading cause of central vision loss in the elderly. Without treatment, Dry AMD can progress as you age, leading to vision loss.

Dry AMD gradually impacts your vision through the following:

Loss of vision: As AMD progresses, your central focus may become smudged, distorted or lost. This impacts driving, recognizing faces, reading, watching TV, and other aspects of your life.
Loss of contrast: It becomes more difficult to see textures and contrasts. This can cause difficulty with navigation uneven walkways and stairs leading to an increased risk of falling.
Impaired depth perception: Difficulty with properly judging distances can lead to accidents and falls.
Poor tolerance for changing light levels: Difficulty with adjusting to changing light levels and worsening glare.
Need for brighter light levels: More light may be needed for daily activities such as reading, cooking and other everyday tasks.

How can the Valeda Light Delivery System help?

Valeda uses Photobiomodulation (PBM) to apply specific wavelengths of light to the eye. Clinical studies have shown that Valeda can improve visual outcomes.

In the aging eye, cells may become sick, leading to loss of function and cell death. PBM works by stimulating energy production within the cells of the eye and improves their ability to perform their roles. Healthy cells are essential for good eye health.

Although PBM is currently used as a therapy in other diseases and conditions, Valeda is the first device designed specifically for dry AMD treatment.

The earlier Dry AMD is diagnosed and monitored by an eye care professional, the better the results will be in treating the disease and preserving your vision. An eyecare professional can determine how frequently you need to be seen for check-ups and treatments based on your unique vision history.

Who is suitable for the Valeda Treatment?

Valeda is indicated for use in the treatment of dry age-related macular degeneration (AMD) patients with vision impairment. Those individuals receiving treatment should have a doctor diagnosis of Dry AMD. The stage of Dry AMD may impact the benefits of the treatment. Your doctor will discuss your diagnosis and treatment plan with you.

Who is NOT suitable for the Valeda treatment?

As a precaution, patients have not been tested and should not be treated with Valeda if they have any known reactions to light exposure, or if they have a history of light-activated central nervous system disorders (e.g. epilepsy, migraine). In addition, patients should not receive treatment within 30 days of using any photosensitizing medications (e.g. topicals, injectables) before consulting with their physician.

What's involved with the Valeda treatment? Do I need any special preparation?

If you wear glasses or contact lenses, you will be asked to remove them prior to receiving treatment. Your eyes will not be dilated for the Valeda treatment. You will be seated comfortably at the Valeda Light Delivery System. The person administering the treatment will guide you through each step of the treatment which takes less than 5 minutes. Treatment for both eyes will take less than 10 minutes.

Clinical trials have shown benefits in visual function following treatment 3 times a week for 3-4 weeks. This is the recommended treatment protocol with Dry AMD. In a recent clinical study, patients received no more than 3 treatments a week and no more than one treatment in a 24 hour period. If you miss a treatment, it is recommended to make up the session within the 3-4 week treatment series period.

What are the clinical benefits of the Valeda treatment?

Treatment with Valeda improves benefits in overall visual function including improvement in vison when scored on the eyechart and improved detailed vision. Photographic imaging also shows improvement in scans of the eye when assessed for drusen (protein deposits that are observed in the diseased eye).

What are the potential side effects of the Valeda treatment?

Photobiomodulation (PBM) is a low level light based therapy that helps cells improve their function. PBM has been used in many different diseases and disorders for decades with a positive safety profile. In clinical trials in dry AMD patients, the use of light therapy has also shown to be safe. Valeda is designed to be eye safe. There have been no treatment-related side effects noted in previous studies with the Valeda.

What can I expect during and after the Valeda treatment?

It is well known that looking at bright light can produce an afterimage. Another name for this is photobleaching, where the cells the "see" that specific colour become fatigued. For example, if you look at red light, those colours may fade after treatment and you will see more of the opposite colour (i.e. green). This phenomenon may be seen immediately following treatment and will recover in a couple of minutes. You will be able to partake in normal activities following the treatment.

What if I have cataracts?

Patients can receive the Valeda treatment if they have cataracts.