The idea of putting electrodes on one’s eyelids might cause many to cringe, but ScyFIX of Minnesota is turning this odd concept into a promising treatment for age-related vision loss. The company has spent eight years developing the first micro-current neuromodulation (MCN) device to treat degenerative eye diseases such as macular degeneration. Over 30 percent of older Americans suffer from macular degeneration, an eye disease in which the patient gradually loses their central vision. Ophthalmologists can expect to see more patients with this condition: As Baby Boomers age, experts predict a 50 percent increase in the prevalence of age-related degenerative eye diseases by 2020. There are currently no approved treatments for several of these diseases, including a form of macular degeneration called dry AMD; and retinitis pigmentosa, in which patients lose their peripheral vision. Given this unmet clinical need, even a one percent share of the Dry AMD market would yield an estimated $3.2 billion in revenue.
The ScyFIX 700 device consists of electrodes connected to a neuromodulator that generates electrical impulses using a very precise algorithm of frequencies. Patients apply the electrodes to their eyes twice daily for 20 minutes per session. According to ScyFIX, the device approximates the electrical activity of a healthy human eye. The electrical stimulation releases neural protectors that improve microvascular circulation and nerve function. In clinical trials, the device helped to improve both distant and near visual acuity, contrast sensitivity, and in the case of retinitis pigmentosa, to expand visual fields. Patients also reported increases in brightness, a decrease in fogginess, enhanced color perception, and reduced blind spots. In clinical trials, says CEO Thomas Harold, patients who couldn’t read eye charts up close at the beginning of the trials are now able to read newspapers, use mobile phones, and recognize faces of family members. Patients using the device reported a mild tingling sensation, flashes of light despite closed eyes, or feeling nothing at all. An earlier version of the device has been used in many countries around the world. ScyFIX has submitted for both European CE MARK approval for the new 700 and hopes to get FDA approval in the U.S. before the end of the year. The company is seeking a multi-national distribution partner to assist in commercializing the new ScyFIX 700 worldwide.
Related video: Thomas Harold, CEO and Founder of ScyFix.