DURHAM, N.C. (WNCN) — A Durham man was a patient in a clinical study for a treatment that was recently approved by the FDA to treat a leading cause of blindness.

On Feb. 17, the FDA approved SYFOVRE as the first and only treatment for Geographic Atrophy (GA), an advanced dry form of age-related macular degeneration (AMD).
It’s a leading cause of blindness that impacts more than one million people in the U.S. and five million people around the world, according to Apellis Pharmaceuticals, Inc.
The global biopharmaceutical company announced the FDA’s approval in a news release.
It comes after clinical studies of SYFOVRE — an injection in the eye.

The FDA approved SYFOVRE for all patients with GA, with dosing flexibility every 25 to 60 days — either monthly or every other month.
Trials in the Triangle
Part of the data in the clinical studies came from right here in the Triangle.
Dr. Eleonora Lad, director of Ophthalmology Clinical Research and associate professor of Ophthalmology at Duke University, served as the lead investigator for one of the studies.
She said most people will develop GA if they live long enough, and over time it will affect the center of the vision.
“It’s a huge deal,” she explained. “This would be the first available treatment to slow disease progression for this area of huge unmet clinical need. It would represent a game-changer, a beginning of a new treatment era for these patients.”
Lad describes it as an inflammatory condition of tissues responsible for vision. She said the treatment addresses inflammation at its core, and prevents further progression and worsening over time.
“I believe the treatment works better and better over time,” she said. “It’s an important message to convey to the patients. for chronic disease [like this one], you need to stay on the treatment chronically, and over time the benefits will increase.”
For Bob, it’s personal

One of Lad’s patients in the trial, Bob Normandin, lives in Durham.
He told CBS 17 he was diagnosed with GA seven years ago.
“I was extremely angry. When I tell you, I’m still angry,” he said.
Because of the diagnosis, he said his retirement did not go as planned. He had to give up several hobbies he was passionate about — tennis, bowling and genealogy.
“The whole time you’re working and you’re planning, you’re planning for your retirement. You’re planning to say ‘ok, when I retire I want to do this.’ But when you start losing your sight, you can’t do it anymore,” Normandin explained.
Though he uses tools to help him see, he sought out the clinical study and signed up to have SYFOVRE administered to his right eye.
“When you get to the point when there’s an ailment in your body and there’s a solution to help that ailment stop or slow down… unless you’re nuts, you’re going to do it,” he told CBS 17.

He said the injection is not as painful as one might think, and doctors numb the eye so it only feels like pressure.
He’s grateful the treatment will give him more time to visit Saratoga, New York, where he was born and raised.
“We’re going to try and get back up there this year, because I love the Adirondack Mountains. Lake Placid, that area and everything else. And I want to see it before I can’t anymore,” Normandin said.
Now that the FDA has approved the drug, he plans to get it in his left eye as well.

He also encourages anyone with GA to talk to their doctor and seek treatment.
Why is it called Geographic Atrophy?
The term ‘geographic’ refers to the shape of the lesion that affects the back of the eye, also known as the retina.
“It has a shape that’s a geographic map-like shape,” Dr. Lad explained. “Atrophy means thinning or degeneration in the dry form of age-related macular degeneration.”
Will insurance cover the treatment?
Lad said the decision of whether insurance companies will cover the treatment rests with the companies themselves, just like all drugs.
However, she said the retina community as a whole is in agreement that this is the beginning of a new treatment era for this patient population that had no available treatments prior.
“We are optimistic that the payers would cover this,” Dr. Lad said.
How do I know if I have GA?
Lad said the first symptom of geographic atrophy is the distortion of straight lines, difficulty reading, and difficulty driving at night.
She said people experiencing this will have a gradual loss of central vision and patches of blind spots or pieces where vision is missing.
As GA progresses, she said the blind spots because larger and deeper, causing more difficulty with vision.
Lad recommends a good eye exam for all adults every year, especially those over age 50.
She said anyone who thinks they have GA should contact their doctor.