Age-Related Macular Degeneration (AMD) is the leading cause of blindness in persons over 50 throughout the western hemisphere. But despite the prevalence and severity of the disease, there is no approved treatment for over 90% of those suffering from AMD. The primary risk factor for (AMD) is growing older.
A person’s chances of developing AMD are about 2% at age 50; 11% between ages 65 and 74; and 25% to 30% after age 74. Other risk factors include a family history of the disease, smoking; high blood pressure and atherosclerosis.
As Dry AMD advances, there is an increase in the number and size of sub-retinal deposits known as drusen, and there is marked degradation of macular cells, leading to blurring of central vision. With continuing degeneration, blurred spots become blind spots, creating a pitted visual field. 15-20% of Dry AMD patients will experience degeneration over their entire macula, a sub-condition known as geographic atrophy.
Approximately one in ten AMD cases develop into the Wet form. In Wet AMD, new blood vessels grow in the macular region. These blood vessels are very fragile and prone to breaking, which subsequently results in retinal scarring and permanent vision loss. While Dry AMD progresses over months, Wet AMD can render significant changes in weeks or even days, and typically has devastating effects: 85% of persons with Wet AMD lose all central vision.
ScyFIX is currently in FDA clinical trials with a microcurrent device that, if successful, could provide sight-saving treatment to millions of AMD patients. The ScyFIX Micro-Current Stimulation (MCS) device delivers tiny yet precise amounts of electrical current into the eyes. The MCS device works at very low power levels, delivering a dosage measured in millionths of an ampere. Electricity enters the eye through a patch placed over the eyelid, with a corresponding patch on the hand to complete the circuit. Research suggests that ScyFIX’s electrical stimulation approximates the level of electrical activity present in a healthy eye, stimulating recovery in diseased or dormant cells.
Treatment history shows ScyFIX therapies stop visual degeneration in 95% of AMD cases and improve vision in 80% of cases. For Dry AMD, there are currently no approved therapies. If MCS treatment passes FDA approval, it would be a highlyeffective, non-invasive option for Wet AMD, and a landmark development for the previously untreatable Dry AMD.
Currently, most treatments for the Wet condition require invasive, costly, complex procedures. Traditional therapies involve using needles to deliver a pharmacological preparation into the eye or cutting the eye and draining the vitreous fluid to perform surgical operations on the retina. The ScyFIX MCS therapy, by comparison, is much more patient friendly. The MCS unit is easy to use and treatments can be self-administered at home. The procedure is painless, has no know side effects, and produces results within the first few treatments.
ScyFIX 600 device is being used outside of the US based on its approval by Australian, Canadian, and European regulators. The 600 is also deployed in many non-European countries that allow usage based on the CE Mark approval. A next generation device, the ScyFIX 650, has finished design and bench-testing stages and is now being used in FDA clinical trials.