Minneapolis, MN - A new treatment that could delay and potentially reverse blindness has been granted CE Mark approval in the European Union.
The new therapy, developed by ScyFIX, uses microcurrent neuromodulation to help prevent vision loss and can even restore sight in patients suffering from low-vision blindness-related diseases. It is also the first device therapy approval for Retinitis Pigmentosa (RP), a degenerative disease where peripheral vision is lost that can result in total blindness. Approvals for the treatment of other blindness-related diseases are expected soon, says the company.
The treatment works by administering a tiny electrical current that stimulates the body’s own healing mechanisms. ScyFIX, based in Minneapolis, says it has been working on the technology for the last seven years.
"The approval of this breakthrough therapy gives hope to the millions of people suffering from low-vision, blindness-causing diseases who have had no therapy options until now," says Thomas W. Harold, founder of ScyFIX and inventor of the ScyFIX 700.
"Patients now report seeing faces of their family members, using mobile phones, reading newspapers and performing day-to-day tasks, which was not possible for them prior to use of the ScyFIX therapy."
RP affects more than two million people worldwide. Since it is degenerative, the condition can often lead to total blindness. But in the study, the visual field - the actual amount the eyes can see - was either expanded or remained stable in 85 percent of patients and actually improved in 63 percent. The ScyFIX 700 was also shown to improve the clarity of vision.
The ScyFIX 700 therapy is available on prescription in all countries that recognize CE Mark. Patients can get the ScyFIX 700 from their ophthalmologist, who will instruct them on the appropriate in-home use.
"ScyFIX will continue to pursue successive regulatory approvals around the world, including the FDA in the United States," said Dr. Darrell DeMello, president of ScyFIX. "This will allow the ScyFIX neuromodulation technology to be used to slow the progression of symptoms for people with devastating blindness-related diseases."
Clinical testing results also show promise for the ScyFIX 700 in the treatment of other vision impairments, including Age-Related Macular Degeneration (ARMD). This condition affects an estimated 50 million people worldwide and has two forms: wet and dry. Wet ARMD occurs in only 10 percent of cases, while the other 90 percent are what is known as Dry ARMD. Once approved, the ScyFIX 700 would be the first approved therapy capable of treating Dry ARMD.