A new drug that could help more than 128 million Americans read without the need for glasses has been submitted to the Food and Drug Administration for approval.
The examination eye drop – called AGN-190584 – is expected to be approved by the end of this year. According to a statement released last week by Allergan Eye Care, an AbbVie company.
The eye drops are a pilocarpine solution used to treat the symptoms of presbyopia, an age-related condition that, according to the Mayo Clinic, results in a gradual loss of the eyes’ ability to focus on nearby objects.
It’s a natural, albeit annoying part of aging, said Dr. Robert S. Bailey, chief of cataract and primary eye care services at Wills Eye Hospital in Philadelphia.
“It happens from the age of 10 and then you gradually lose that ability to focus until you are 70, when you lose the ability completely,” he said. Most patients notice it in their mid-40s.
Presbyopia is caused by the loss of elasticity in the lens of the eye, which makes it more difficult to change shape when shifting focus from objects that are far away to closer.
The eye drops do not treat the cause of presbyopia, but rather help treat its symptoms. Instead of aiming at the lens of the eye, the drops shrink the pupils of the eyes and create a pinhole effect that increases the depth of field.
“When you have a camera and you make the aperture small (and let in little light) the depth of field – or the distance things are in focus – is much greater than if you open the camera,” Bailey explained. “It gives you more depth of field, not only far away, but closer too.”
The new drug use is based on two randomized studies with 750 participants aged 40 to 55 years in which patients were treated either once daily with the drug or with a placebo for 30 days.
The studies found the eye drops were safe and effective, with participants receiving three more rows on the reading table in low-light conditions than those receiving the placebo. According to test results published by the company in October 2020. The eye drops began to work just 15 minutes after insertion, but reached their maximum effectiveness after about an hour.
Non-serious side effects, which occurred in less than 5% of patients, included headache, red eyes, blurred vision, and some eye pain.
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When FDA clears AGN-190584, it will be the first eye drop to treat presbyopia. However, pilocarpine eye drops have already been approved in higher concentrations for glaucoma patients.
These patients use it about four times a day at a concentration of 4%; Presbyopic patients are only allowed to use it once a day or 1.25% as needed, said Dr. Michael Robinson, Vice President and Head of Global Therapies at AbbVie. Future studies will look at how the drug works when used more than once a day, he added.
“In glaucoma, pilocarpine (pilocarpine) improves the flow of fluid from the eye and lowers intraocular pressure,” he said. “Here (in presbyopic patients) we are using pilocarpine to basically constrict the pupil.”
This could make driving at night dangerous, but the FDA will put warning signs in place after the drug is approved, Robinson said. Other warnings may also include caution when operating heavy machinery, especially in poor lighting conditions.
While the target audience is currently patients with mild to moderate presbyopia in their forties and fifties, the company plans future studies to evaluate the drug in elderly patients. He doesn’t see the eye drops completely replacing the reading glasses, but believes this could be another tool.
“Presbyopia frustrates a lot of people when they need reading glasses,” said Bailey of Wills Eye Hospital. “This is one way of potentially dealing with it.”
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
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