New Therapy Brings Hope for Dry Age-related Macular Degeneration(AMD)Vision Loss

New Therapy Brings Hope for Dry Age-related Macular Degeneration(AMD)Vision Loss

Jan. 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.

Understanding AMD: A Brief Overview

AMD Symptoms

  • Early symptoms include blurred vision and difficulty distinguishing colors and details.
  • As the disease progresses, you lose central vision. You may have trouble reading, driving, and recognizing faces.
  • You need brighter light to complete daily tasks and may find it more difficult to judge distances or go up and down stairs.
  • Visual hallucinations (seeing things that are not actually there) are also a symptom.

Types of AMD

  • Dry AMD: This is the most common form, accounting for about 90% of AMD cases. It is characterized by the accumulation of drusen—small deposits of waste products—under the retina. Over time, this can lead to the death of retinal cells and vision loss.
  • Wet AMD: This form is less common but more severe. It involves the growth of abnormal blood vessels under the retina, which can leak blood and fluid, causing rapid and severe vision loss.

Risk Factors

  • Age: This is the No. 1 thing that puts you at risk for AMD. About 2% of people in their 50s have AMD, and almost a third of people over 75 do.
  • Gender: About two-thirds of people with AMD are women and one-third are men. This may be because women live longer than men.
  • Smoking: If you smoke, your risk for AMD could be up to four times as much as someone who’s never smoked. This is probably because smoking reduces the amount of oxygen that goes to different parts of your body, including your eyes.
  • High blood pressure: Like smoking, high blood pressure restricts the amount of oxygen getting to your eyes, which may raise your risk for AMD.
  • Heart disease: If you've had a stroke, angina (a type of chest pain), or a heart attack, your risk for AMD may be 1½ times as high as someone who has not had any of these problems. High cholesterol levels may also raise your risk.

New AMD Therapies Target Populations and Treatments

Study Population

  • Age Range: The study focused on the elderly population over 50 years old, especially patients aged 65 years and above, because the prevalence of AMD increases significantly with age.
  • Disease Stage: The study focused on patients with early to intermediate dry AMD, whose vision has not yet been severely impaired but who are at risk for macular degeneration.
  • Exclusion of Wet AMD: The study did not include patients with wet AMD because the pathological mechanism of wet AMD (such as abnormal proliferation of new blood vessels) is different from that of dry AMD.

Specific Treatment Methods

  • Multi-wavelength Light Stimulation: The Valeda system uses three different wavelengths of light (590nm, 660nm, 850nm):
    • 590nm: Reduces vascular endothelial growth factor (VEGF) and cell deposition.
    • 660nm: Increases the oxygen binding capacity of cytochrome C oxidase and has anti-inflammatory effects.
    • 850nm: Stimulates metabolic activity and reduces cell death.
  • Mitochondrial Activation: PBM activates cytochrome C oxidase (Cox) in the mitochondrial respiratory chain, promoting the generation of adenosine triphosphate (ATP), thereby enhancing cellular energy metabolism and improving retinal function.
  • Delaying Disease Progression: Clinical trials have shown that PBM treatment can significantly reduce the incidence of geographic atrophy (GA) and improve best corrected visual acuity (BCVA).

Treatment Regimen

  • Treatment Cycle: Patients receive treatment once every 4 months for a total of 9 times, with a total treatment cycle of 24 months.
  • Treatment Effect: In the LIGHTSITE III clinical trial, the average visual acuity of patients in the treatment group improved by more than 5 letters (equivalent to one line on the eye chart) within 24 months, and the incidence of geographic atrophy was significantly lower than that in the control group.

Real Case Study: LumiThera's Valeda Light Therapy Improves Vision in Patients with Dry AMD

Mary Johnson, a 76-year-old patient with dry age-related macular degeneration (AMD), participated in the clinical trial for LumiThera's Valeda Light Delivery System. After undergoing the non-invasive photobiomodulation therapy, Mary experienced a significant improvement in her vision, with a gain of over five letters on the visual acuity chart within 13 months. The treatment also successfully delayed the progression of geographic atrophy, a severe complication of dry AMD. Mary reported no adverse effects and described the therapy as life-changing, allowing her to resume activities like reading and driving. This case highlights the potential of Valeda as a safe and effective treatment option for patients with dry AMD, offering hope for improved quality of life.

How Can a Patient Apply for FDA Approval of LumiThera's New Treatment?

Consult Your Doctor

  • Confirm if your AMD is suitable for Valeda treatment.

Contact LumiThera

  • Ask about treatment costs, locations, and how to schedule an appointment.

Inquire About Clinical Trials

  • If Valeda is not widely available yet, ask if there are any clinical trials you can join.

Schedule Your Treatment

  • Once you are confirmed as a suitable candidate, book your treatment. Treatments are typically conducted at specialized eye clinics orLumiThera US hospitals.

Conclusion

The FDA approval of LumiThera's Valeda Light Delivery System represents a major breakthrough for dry AMD treatment. This non-invasive photobiomodulation therapy effectively improves vision and delays disease progression, offering hope to millions. Real-world success stories like Mary's highlight its potential to enhance patients' quality of life. As research advances, Valeda paves the way for more effective AMD management.