A new drug that could help more than 128 million Americans read without needing glasses has been submitted to the Food and Drug Administration for approval.
The experimental eye drops – called AGN-190584 – are expected to be approved by the end of this year, according to a statement released last week by Allergan Eye Car, an AbbVie company.
Eye drops are a solution of pilocarpine intended to treat the symptoms of presbyopia, which is an age-related condition that causes the eyes to gradually lose their ability to focus on nearby objects, according to the Mayo Clinic.
It’s a natural, albeit boring, part of aging, said Dr. Robert S. Bailey, chief of cataract and primary eye care at Wills Eye Hospital in Philadelphia.
“It happens from (the age of) 10 years old, and then you gradually lose that ability to concentrate until the age of 70 when you totally lose the ability,” he said. Most patients begin to notice it in their mid-forties.
Presbyopia is caused by the loss of elasticity in the lens of the eyes, which makes it more difficult to change shape when shifting the focus from distant objects to closer objects.
Eye drops do not treat the cause of presbyopia but help treat its symptoms. Instead of targeting the lens of the eyes, the drops make the pupils of the eyes smaller, creating a pinhole effect that increases depth of field.
“If you have a camera and you lower the aperture (and let in) little light, the depth of focus – or how far things are in focus – is much greater than if you open it up.” the camera, ”Bailey explained. “It gives you a greater depth of focus, not only far but also closer.”
The new drug claim is based on two randomized trials of 750 participants aged 40 to 55 where patients were either treated with the drug or with a placebo once daily for 30 days.
The studies found the eye drops to be safe and effective, with participants gaining three more rows on the low-light reading chart compared to those who received the placebo, according to trial results released by the company in October 2020. The eye drops started to work as soon as possible. 15 minutes after placement, but reached peak effectiveness after about an hour.
Non-serious side effects that occurred in less than 5% of patients included headache, red eyes, blurred vision, and eye pain.
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If approved by the FDA, AGN-190584 will be the first eye drops to treat presbyopia. However, pilocarpine eye drops have already been approved at a higher concentration for patients with glaucoma.
These patients use it about four times a day at a concentration of 4%; patients with presbyopia can only use it once a day or on demand at 1.25%, said Dr Michael Robinson, vice president and head of global therapeutics at AbbVie. Future trials will look at how the drug works when used more than once a day, he added.
“In glaucoma, (pilocarpine) improves the flow of fluid from the eye and this lowers intraocular pressure,” he said. “Here (with patients with presbyopia) we use pilocarpine to constrict the pupil.”
It could make nighttime driving dangerous, but the FDA will determine the warning labels after the drug is approved, Robinson said. Other warnings could also include caution when operating heavy machinery, especially in low light conditions.
While the target population is currently mild to moderate presbyopia patients in their 40s and 50s, he said, the company is planning future trials to study the drug in older patients. He doesn’t see eye drops as a complete replacement for reading glasses, but thinks it could be another tool.
“Presbyopia is a frustrating thing for many people in terms of the need for reading glasses,” said Bailey of Wills Eye Hospital. “It’s a potential way to handle it.”
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
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