New Therapy Brings Hope for Dry AMD Vision Loss

January 7, 2025 — A new light therapy device could be a game-changer for millions at risk of vision loss. The FDA has approved a first-of-its-kind treatment for dry age-related macular degeneration, a leading cause of blindness in adults over 55.

Developed by LumiThera, Inc., the device showed promising results in a clinical trial, marking it as the first effective therapy for AMD. Approved under the FDA’s “De Novo” process, the treatment offers hope where no similar options existed.

The LumiThera study, done at 10 retinal centers in the United States, assessed the safety and effectiveness of the system on the eyes of 100 people over a 24-month period. The data collected during the trial was then analyzed over a 13-month period.

The trial found that LumiThera’s Valeda Light Delivery System significantly reduced the risk of vision loss and the start of geographic atrophy in dry AMD. More than 58% of the people studied reported improvements in their sight after the therapy.

Geographic atrophy is a treacherous hallmark of late-stage dry AMD, in which cells in the center of the eye’s retina — called the macula — die, which can cause severe vision loss in advanced forms of the disease.

LumiThera’s system is the first treatment authorized by the FDA for vision loss from dry AMD. AMD is a leading cause of irreversible blindness or vision loss in people over 60. Around 20 million people in the United States have AMD, with dry AMD accounting for 90% of diagnosed cases. It’s considered “dry” because it doesn’t involve the growth of abnormal blood vessels, the way the “wet” form of AMD does.

The percentage of people with dry AMD who lose their vision depends on how severe the disease is and whether it becomes the wet form, which is more severe than the dry form. The wet form is marked by blood vessels leaking into the macula and the loss of central vision. Around 10%-15% of dry AMD cases become the wet form.

During a presentation this year at a meeting of the American Society of Retina Specialists, Eleonora Lad, MD, PhD, vice chair of Ophthalmology Clinical Research at Duke University Medical Center, said the treatment — known as “photobiomodulation” (PBM) — is the first to deliver “meaningful effects” in dry AMD.

“This…treatment will have a huge impact on the standard of care of patients with dry AMD because it will allow retina specialists and practitioners to intervene at earlier stages before photoreceptor loss is irreversible, before the late-stage disease,” she said.

Lad was one of many doctors and researchers who headed the clinical trial.

But how does PBM work, and what specifically improved in the eyes of the people in the study to help combat the disease?

Specific Wavelengths of Light Improve Cellular Function

Until now, taking nutritional supplements (vitamin C, vitamin E, lutein, zeaxanthin, zinc, and copper) was among the most common ways of treating dry AMD. The efficacy with this combo of nutritional supplements was established by the Age-Related Eye Disease Study 2 (AREDS2). The supplements help lower the risk of advanced dry AMD and wet AMD.

There are also recently approved eye injections for dry AMD, such as the drugs Syfovre and Izervay, to treat later stages of the disease. But while both Syfovre and Izervay can slow the progression of geographic atrophy by about 14%-20%, patients receiving either drug have a higher risk of getting wet AMD, and the treatments are invasive. The drugs must be injected directly into the middle of the eye around once per month.

PBM works by delivering specific wavelengths of light to the retina that help cells in retinal tissue, increasing energy production by mitochondria in eye cells, decreasing inflammation, and increasing nutrients and oxygen for cells. This improves cell survival in dry AMD and could slow the disease or stop it from reaching later stages.

Several eye disorders may be partly caused by oxidative stress and impaired mitochondrial function. The wavelength of light used in PBM stimulates an enzyme in eye cells that is key to healthy cellular function and vision.

Research has shown that PBM prevents oxidative stress, which damages retinal pigment epithelial cells and could lead to AMD.

More Study Is Needed

PBM has been around for decades and has been promoted as a treatment for dementia, smoking cessation, spinal cord injury, and wound healing, along with AMD.

“Google photobiomodulation or light therapy, and you’ll find it’s supposed to fix everything…people try to sell it for everything, and that’s because they own the equipment, and they’re looking to recoup their costs,” said Jason M. Miller, MD, PhD, a retinal disease specialist at the Kellogg Eye Center at the University of Michigan School of Medicine.

He said more rigorous and larger trials are needed before PBM therapy should gain wider FDA approval.

The FDA’s De Novo approval process is for medical devices that have designs that are unlike others already on the market. To get full approval from the FDA, a new drug or device must be assessed in a clinical trial that involves more people than the 100 or so that LumiThera used in its trial. For example, phase III trials for drugs usually involve 1000 to 3000 people.

Syfovre’s phase III clinical trials involved 1258 patients.

Research has shown that perceptions of visual acuity could also color the study results in a way that distorts the actual effectiveness of treatment, the way the placebo effect works. Some people in studies may simply think their vision is improving because they know they’re getting treatment.

In a 2022 study, researchers showed that people in a trial who were given a placebo with the expectation the treatment would work reported a more favorable response to treatment than those who received a “nocebo” they were told wouldn’t work.

The sensitivity of response to the placebo/nocebo treatments were shown to rely on the expectations caused by the experiment, and the study’s findings provided evidence that “both ocular accommodation and stereoacuity can be influenced by manipulating expectations and belief about the efficacy of an inert treatment.”

“The placebo effect in medicine is just rampant. It accounts for, in some trials, 30% to 40% of an effect.…I would have a hard time buying this device right now. I don’t want to say it’s ineffective, I just want more data,” said Miller.

SOURCES:

Caltrider D, Gupta A, Tripathy, K. Evaluation of Visual Acuity, StatPearls — NCBI Bookshelf, 2024.

Ophthalmology Times: “ASRS 2024: Results of the LIGHTSITE III Study.”

International Journal of Molecular Sciences: “Effect of Photobiomodulation in Suppression of Oxidative Stress on Retinal Pigment Epithelium.”

LumiThera: “LumiThera Obtains FDA Authorization of Valeda Treatment for Dry AMD Patients to Improve Vision.”

National Eye Institute: “Age-Related Eye Disease Studies (AREDS/AREDS2).”

McGill Office for Science and Society: “The Hype Around Photobiomodulation.”

UCL Institute of Ophthalmology: “The Retina and Retinal Pigment Epithelium (RPE).”

Ophthalmic and Physiological Optics: “Manipulating Expectancies in Optometry Practice: Ocular Accommodation and Stereoacuity Are Sensitive to Placebo and Nocebo Effects.”

American Academy of Ophthalmology: “Vitamins for AMD.”